White Papers are written by organizations to explain a specific business practice, service, product or technology, and provide useful information to readers looking to understand this problem and enhance their job performance. There is no standard subject matter or presentation format but White Papers typically present data supported by facts, figures and statistics to explain the problem and its potential solution. They are generally 2500 words long but can be longer if the topic requires more in-depth discussion, and are written in a narrative voice with no quotes.
White Paper Library
ProEd Regulatory, HGC Regulatory Powerhouse White Paper
Embrace the Opportunities in a Changing FDA Advisory Committee Landscape
Over the past four years, we’ve seen seismic shifts in the conduct of FDA Advisory Committee (AdCom) meetings. Changes already in place and those on the horizon are creating new challenges for sponsors. The biggest challenge has been adapting to the virtual format, which then morphed into a hybrid format, and is now transitioning back to in-person meetings. In addition, sponsors have had to deal with tighter timelines for point-counterpoint briefing documents and shared Q&A with the FDA. These challenges also create opportunities for a productive and transparent dialog with clinicians and regulators.
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Dimensions White Paper
The Role of Digital Tools in Medical Affairs
How the medical affairs function overcomes critical pain points with digital and AI tools: As digital technology has quickly grown, so has the role of medical affairs, a trend that will continue in the future. Medical affairs professionals are no longer solely responsible for medical accuracy but are now driving overall medical strategy and need as much support as possible to carry out these activities efficiently and effectively. Discover why efficiently assigned resources and new technologies are pivotal to the success of medical affairs teams.
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Glemser White Paper
ePI & the Future of Pharma Labels: Reinventing Content Authoring to Improve Patient Outcomes
This guide delves into the profound impact of electronic Product Information (ePI) on the pharmaceutical industry and healthcare ecosystem, exploring how it not only revolutionizes content authoring but also sets the stage for a future where patients are empowered with accessible, personalized, comprehensible information about their health and medications. It also focuses on how AI-powered structured content authoring platforms help equip companies with the tools to streamline and enhance their content-authoring and -management processes, getting them ready for an ePI world.
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IQVIA White Paper
Enhancing Patient Safety: A Paradigm Shift Through Early AI Adoption in Pharmacovigilance Workflows
Traditional PV operations typically start at Case Processing, but the persistent challenge of underreported adverse drug reactions (ADRs) demands a paradigm shift. US FDA’s estimate that only 1%–10% of ADRs reach the FDA Adverse Event Reporting System underscores a need for a more proactive strategy. This paper stems from the FDA Discussion paper on Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products , which highlighted the applications for PV beginning at the Case Processing stage. However, the emphasis on identifying adverse events remains a pivotal precursor to effective processing. Vast unstructured data, often beyond a company’s control, poses a considerable hurdle in this endeavor.
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Glemser White Paper
AI & Global Labeling: How Next-Gen Tools Are Streamlining Structured Component Authoring Effectively and Compliantly
Outside of the physical drug product itself, global labeling plays the most fundamental role in helping pharmaceutical companies deliver safe and effective therapies to the population. But the process behind global labeling—the authoring, editing, collaborating, translating, and publishing of drug labels—is both incredibly complex and time-consuming. This guide explores how AI-powered tools are helping teams simplify and accelerate their in-house authoring workflows, without sacrificing compliance. It also explains how, by using such tools, companies can transform not just the way they work but also the entire “last mile” of the drug development lifecycle.
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Merative White Paper
Adaptive Clinical Trial Success via a Unified Data Management and Acquisition Platform
Adaptive trials—clinical trials whose design allows for planned modifications to one or more trial aspects based on accumulated data—can range from early-phase studies and exploratory trials to studies conducted to satisfy post-marketing commitments. Using adaptive design in an exploratory setting can allow, for example, evaluation of a broad range of doses, regimens, and populations, giving investigators the opportunity to continue evaluating only the most promising possibilities. In short, adaptive designs maximize the trial’s potential and utility based on data gleaned through the study.
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University of Cincinnati White Paper Podcast
Master of Pharmaceutical Sciences in Drug Development Online Program
Drug development is a complex, lengthy, and expensive process requiring extensive training and experience in numerous areas. The University of Cincinnati’s fully online Masters in Pharmaceutical Sciences in Drug Development program—a collaboration between academia, industry, and government—prepares students for the multidisciplinary process of translating a therapeutic concept from lab bench to bedside. “This curriculum provides details that would take an individual working in a particular field a long time to get good exposure to, and what you need to be aware of before you can initiate any human trials, to how you make the best of the opportunity,” explains program director Pankaj Desai, chair of the university’s Pharmaceutical Sciences Division. “Working with human patients is a great privilege. We have to be very mindful of the respect and ethical issues that go along with that.”
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Indegene White Paper Podcast
Digital Tools Building Data Speedway from Bench to Market
How can current clinical data expertise incorporate real-world data (RWD), artificial intelligence (AI), and machine learning (ML) to make research more effective and efficient? “Informed by patient feedback via surveys and other mechanisms, real-world evidence could influence study design and protocol optimization by ensuring hybrid configurations and allowing for diversity, equity, and inclusion,” explains Indegene Head of Enterprise Clinical Ram Yeleswarapu. “From bench to market, discovery leading to the development and launch of safe and effective therapies will get accelerated by AI-ML. This will perhaps reduce or eventually obviate testing in animals and humans and enhance digital twins simulating these behaviors. AI-ML could play a very disruptive role as we look ahead.”
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IQVIA White Paper
Technology’s Role in Addressing Potential Drug Safety Risks
While not all safety data sources are amenable to automation (and human review will always remain a critical component), artificial intelligence (AI) and natural language processing have proven to be effective, when properly applied to the right scenario, in drug safety monitoring. This paper discusses key learnings in applying an AI-enabled safety risk detection system to many different scenarios across multiple therapeutic areas and offers recommendations for developing a robust drug safety monitoring program to better comply with regulatory requirements.
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IQVIA White Paper
Innovative Technologies for Efficient and Effective Label Change Process
Drug labeling has emerged as a vital conduit for relaying essential medication information such as drug names, strengths, indications, contraindications, dosages, and administration instructions to healthcare practitioners and patients. Pharmaceutical companies are exploring innovative technologies to augment (not replace) regulatory professionals for managing and executing label changes. By leveraging the transformative capabilities of artificial intelligence and machine learning, organizations can free up valuable staff time, allowing them to focus on higher-value activities and strategic decision-making.
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Think Company White Paper
Modern HCP Portal Strategies for Pharma Leaders: An Industry Assessment
Today’s top US biopharmaceutical companies are working to improve the digital experience of their HCP portals and implement modern HCP goment strategies—but few leaders have the industry data they need to understand their opportunities in the larger landscape. In this report, Think Company compiled data on 39 HCP portals from the top 20 US pharmaceutical companies to gather insight into who is leading the way in digital maturity, the trends we’re observing in updates over time, and the modern best practices for pharmaceutical leaders who want to better go with HCPs, earn trust, and build their brand reputation.
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IQVIA White Paper
eCTD 4.0 Implementation: Including Understanding of Regional Differences and Benefits
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and other regulatory reports to health authorities around the world. eCTD v3.2 has been the default version for more than 10 years since its release in 2008. The initial draft implementation guidelines for eCTD 4.0 were developed between 2015 and 2016 to improve robustness, flexibility, long-term stability, and a more advanced lifecycle management process. After many years of collaboration with regulatory bodies and industry sponsors, eCTD version 4.0 is finally ready for implementation.
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Salesforce White Paper
The Pharma Technology Playbook
Pharmaceutical companies must continue to drive innovation even in the face of enormous challenges. From increased pressure in drug pricing to reimbursement constraints to the competitive nature of biosimilar products, success depends on a company’s ability to stay agile, increase efficiencies, and do more with less—all while continuing to improve the consumer experience. Learn how an integrated health and life sciences platform can power innovation, drive internal efficiencies, and help deliver the kinds of experiences patients and consumers have come to expect.
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Slope FierceBiotech White Paper
How to Optimize Clinical Supply Chain Management with Slope
Successful clinical trial execution requires orchestrating multiple moving parts, with everything from protocol design and patient visit schedules to lab kits and biological samples needing to seamlessly line up to ensure on-time, on-budget delivery of high-quality data. Today, increasingly complex clinical trials are straining supply chain management. Sponsors can struggle with this complexity, leading to time and budget overruns, compliance issues, increased patient burden, and data integrity problems. This White Paper explains how a sponsor overcame these problems by adopting an eClinical Supply Chain Management platform.
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Appian White Paper
Three Challenges Facing Study Start-Up and the Low-Code Automation Solution
The life sciences industry has been exploring ways to accelerate the study start-up (SSU) process to get products to patients who need them faster for quite some time. However, managing the complex SSU process end-to-end, from study award to first patient in, can be lengthy and complicated. Read this whitepaper to see how a low-code automation platform can help the study start up and the life sciences product lifecycle, including:
Sharing source data
Initiating handoffs between functional areas
The swivel chair effect.
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Hexaware White Paper
Transforming Patient Journey in Clinical Trials
80% of the critical clinical trials in life sciences and pharma organizations get delayed due to patient recruitment issues. Digitally transforming the Life Sciences and Healthcare industry can enhance patients' journeys in clinical trials and, in turn, increase participation, reduce dropouts, and make the trials cost-efficient. Read this whitepaper to know more about:
The challenges in traditional clinical trials
Ways to transform patient journeys through digitization
Effective patient goment strategies.
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Syneos White Paper Podcast
The Power of an End-to-End Drug Development Solution
How can a lifecycle mindset accelerate the discovery, development and delivery of innovative drugs and other therapies? “There's a real competitive landscape out there when it comes to drug development, and it makes sense for everybody in this equation to get the best out of ensuring that a treatment coming to the market has the best chance of getting there,” explains Bharat Chudasama, Vice President, Syneos One® at Syneos Health. “The product development mindset says: We need to get this treatment prescribed. In order for me to get that treatment prescribed, I need to think about if payers are going to be willing to pay for it. In order for those payers to pay for it, they need to be able to see the evidentiary benefit to patients, to the system, in terms of safety and everything else.
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Phlexglobal White Paper
Phlexglobal Guide: Best Practices for RIM Business Process Automation
Regulatory teams at life science companies are finding that effective regulatory information management (RIM) has become critical to operations. The increasing complexity of regulatory processes remains a key obstacle to realizing the full benefits of RIM systems. A recent industry survey of regulatory professionals identified “defining and implementing globally standardized business processes” as their top business challenge. Business process automation designed for life sciences regulatory and incorporated into end-to-end RIM software is emerging as an important enabling technology to meet this challenge.
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Medrio White Paper
Medrio: The Rise of Hybrid Clinical Trials
Although decentralized trials (DCT) existed prior to the pandemic, COVID-19 undoubtedly had a large impact on the rapid adoption of DCT technologies. As global regulators become more accepting of these novel technologies, patients become accustomed to using them, and DCT enters the mainstream lexicon, it’s important to distinguish how and where it will benefit clinical research the most. This paper defines what a hybrid trial is, how it utilizes decentralized technologies, and the reason for mainstream adoption of hybrid clinical trials.
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4G Clinical White Paper Podcast
DTP Emerging as Practical Patient-Centricity
One of the most basic aspects of critical trials, helping patients maintain their therapeutic regimens, was greatly impacted by the travel and social restrictions of COVID-19: Delivering and distributing investigational drugs to maintain the trial while keeping patients and site employees safe in the process. “The pandemic forced everyone to think differently. We were all running a crisis and the main challenge was how to keep patients under treatment. Direct to patient (DTP) means shipping the drug to the patient home, or to patient location according to his choice, instead of having the patient coming to the clinical site. That allows patients to stay at home. There is no need to go anywhere and jeopardize their immune system in a pandemic,” explains Neta Bendelac, Senior Director of Strategy, 4G Clinical.
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Calyx White Paper Podcast
CTMS Key to Unlocking Clinical Data Power
Clinical trial management systems (CTMS), which have historically been large clinical data repository and management systems, are responding to changes in research necessitated by the pandemic. “We demand data to work much harder for us now. We want things to be intuitive and at our fingertips. We firmly believe a CTMS solution shouldn’t be any different. Data needs to work hard to support the client's business, provide a seamless, interoperable solution that users and stakeholders find intuitive and drive the success and velocity of the clinical trial,” suggests Serena Barker, Vice President, eClinical Operations for Calyx. “We see CTMS as just one of a number of important components that now exist in a much more integrated and interoperable system that spans everything from the drug discovery process, trial operations (where the CTMS sits), through sales, marketing enablement, and all the way into manufacturing,” concurs Calyx Vice President of Engineering Stephen Tait.
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dMed Global-Clinipace White Paper Podcast
dMed Global/Clinipace Building Bigger Business Than Both
dMed Global, a full-service clinical contract research organization (CRO) headquartered in China, and Clinipace Incorporated, a full service clinical CRO with US headquarters, announced the merger of the two companies in April 2021. “Western biotech companies increasingly recognize their need for a strategic partner who can stay on the leading edge of fundamental changes in the global clinical landscape,” explains Dr. Lingshi Tan, Founder and Chairman of dMed Global and Global CEO for dMed/Clinipace. “We know that the drug development market in China is growing at greater than 20% a year per annum, and that is almost three times as fast as clinical research in the rest of the world,” says Jason Monteleone, Clinipace CEO who will serve as Chief Business and Strategy Officer for dMed/Clinipace.
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IBM Watson White Paper Podcast
Future of Life Sciences: Vision for Smarter Healthcare
The global pandemic, even with its disruption and tumult, helped the healthcare industry rediscover that necessity is the mother of invention. “It probably catapulted the life sciences industry forward by at least five to ten years.” suggests Lorraine Marchand, Vice President and General Manager, IBM Watson Health. But are we where we should be, and what’s next? Join us to learn how data and technology will shape the future of healthcare, and how IBM Watson Health plans to tackle some of the most critical challenges facing Life Sciences today.
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Matrix Medical Network White Paper Podcast
Decentralization Bringing Research and Patients Closer
As clinical researchers, like other professionals, learned to work virtually and remotely during the pandemic, the biggest impact on clinical trials might be the accelerated adoption of decentralized clinical trials. “A traditional clinical trial is focused very much around research sites and the principle investigators (PI) managing the trial. When thinking about a decentralized trial, it’s really about flipping the lens to fully focus on the participants. Instead of a trial being about a site, and a PI, it becomes about a participant who's actually living and breathing that trial, all day, every day,” explains Thaddeus Wolfram, President, Matrix Clinical Trials. “Equally important is removing or lessening that intimidation and hesitancy of involving or signing up as a participant of a potential trial,” continues Brandi Buzzetta, Director of Account Management, Matrix Clinical Trials.
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NNIT White Paper Podcast
Digital Business Transformation: Technology Plus Culture Equals Innovation
The power of emerging technologies and data (re)use can help organizations transform business processes, respond to rapid market development, and decrease time to market. “Transformation of the business is related to being able to reuse your data and your documents to optimize the process,” explains Michael Agard, NNIT Managing Consultant for US. “Most companies focus on their internal business users, meeting the needs of their requirements. It really takes an outward look to the patients and the investigators: How can we support their journey?” “We see data-driven technology-enabled clinical trial conduct as being core for how we want to use digital technology to improve our clinical development,” continues Franciska Darmer, Advisory Director, Global Head of Clinical, NNIT.
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PPD White Paper Podcast
Achieve Operational Excellence Throughout the Product Lifecycle
As an important tool in developing oncology therapies and COVID-19 vaccines and treatments, the increased visibility of master protocols has added to interest from sponsors pursuing master protocols in other therapeutic areas. “This pandemic required transparency in drug development research outcomes and collaboration between regulators and drug developers. This necessitated rapid global adaptation of innovative trial designs, such as master protocols. Clearly, drug development has shifted based on that successful model,” suggests Pat Mann, Senior Director, Regulatory Affairs, PPD.
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SDC White Paper Podcast
Data Science & Automation Driving Research Science Forward
In clinical research, only one thing is guarded as carefully as the patient – and that is the data that patients help generate. For biometrics clinical research organizations, developing and integrating a data science and automation department into operations is a critical component of modern trial management. How are advances in data science changing research science? “We all recognize clinical trial data hosts a wealth of information, and data science allows us to analyze and present this information enabling us to make more efficient decisions around our protocol development and study execution,” explains Dale Usner, Statistics & Data Corporation (SDC) Chief Scientific Officer and Senior VP of Strategic Scientific Consulting, in this Q&A with SDC Senior VP of Business Development Jim Townsend. “Analyzing historic and current information will be a real benefit towards enabling a robust protocol to be built and executed more expeditiously while retaining high quality.”
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IBM Watson White Paper Podcast
Future of Life Sciences: Vision for Smarter Healthcare
The global pandemic, even with its disruption and tumult, helped the healthcare industry rediscover that necessity is the mother of invention. “It probably catapulted the life sciences industry forward by at least five to ten years.” suggests Lorraine Marchand, Vice President and General Manager, IBM Watson Health. But are we where we should be, and what’s next? Join us to learn how data and technology will shape the future of healthcare, and how IBM Watson Health plans to tackle some of the most critical challenges facing Life Sciences today.
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Medrio White Paper
Medrio’s Patient goment Guide for Sponsors and CROs
In light of the past year, sponsors and CROs must focus now, more than ever, on building patient goment into their study builds from the ground up. This involves applying the patients’ perspective into recruitment and outreach strategies, removing barriers for entry and retention, and creating healthy two-way information exchanges between patients and their clinical teams. But effective, sustainable patient goment goes beyond single-focused solutions for recruitment and retention. This white paper focuses on how sponsors and CROs can put themselves into the mindsets of their patients and find strategic ways to incorporate patient goment into the entire trial lifecycle.
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LARVOL White Paper Podcast
Emerging Trends in Immuno-Oncology Trial Design
Recent approvals of multiple immune checkpoint inhibitors, which help the body target and combat cancer cells, has both changed the standard of care in different cancers and brought cancer research to a critical juncture. “When you want to design a clinical trial and observe benefit for a new drug, you have to take into account all the other treatments given as standard of care for that type of cancer. Overall, we are working in more specific subgroups of the disease, which means automatically smaller cohorts, and the challenge is to monitor not only the treatment you add but all the other treatments given as well,” explains Charlotte Moser, Vice President, Clinical Development, Galera Therapeutics, Inc. “The longer timeline makes clinical trial design in immunotherapy especially difficult, and we still have a lot of work to do in terms of predicting response and how to best use biomarkers,” says Kinisha Gala, Project Owner of Oncology, LARVOL.
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Kinapse White Paper
Document Quality Control Emerges as a Discipline in Its Own Right
Compiling a quality regulatory submission is a basic requirement for biopharmaceutical companies. Poor quality documents could lead to rejection of a regulatory application, requiring significant rework and delays to regulatory decisions. What do we mean by quality in regulatory documentation? Fundamentally, the conclusions drawn from the source data must be robust, but references to source data must also be accurate, and the documents must be free of formatting errors. Investment in a thorough and efficient approach to document QC focused on accuracy, consistency, and style is a “must have” for biopharmaceutical companies.
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Covance Patient Safety White Paper Podcast
Virus Variants No Threat to Vaccine Safety
In early 2021, millions of people began receiving vaccinations to prevent COVID-19 infection. This global rollout of vaccinations in such a relatively short timeframe, complicated by virus variants emerging in many countries, presents enormous and previously unseen challenges to professionals working to ensure the safety of these vaccines. “The virus is still adapting itself to be sure that it can still reproduce although there are many people that are vaccinated,” explains Jerome Premmereur, Head of Global Drug Safety and Pharmacovigilance, Covance Patient Safety Solutions. “So far, so good. When you look at the British one and the British numbers, we identify quickly that when there is nearly only one variant, it is really impacted by the vaccine.” Similar stories in different countries and different vaccines (i.e., Israel and Pfizer vaccine) have also been observed.
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InterSystems White Paper Podcast
Learning Health Systems Creating Virtuous Circles of Care
With so much real-world data available, how can pharmaceutical and healthcare delivery organizations achieve alignment to maximize its value? “Sponsors definitely recognize the value of real-world data, real-world evidence, and they're getting more comfortable working with health systems to find meaningful use cases using the health system data. The desire is there, the capability is there, and people are willing to generate evidence together and help each other on a global scale,” explains InterSystems Physician Executive Dr. Qi Li in this interview with healthcare and technology writer Jack Murtha. “A learning health system is a system that seeks to continuously generate and apply evidence innovation, quality, and value in health care, and the aim of the learning health system is to really enable that continuous, efficient, and rapid cycle of study feedback and then subsequent practice change,” concurs Matthew Stannard, InterSystems Life Sciences Advisor. “This concept of a virtuous circle that provides care, collects data, and then feeds those data back into the care process and continuously improves insights and outcomes is where we see the future headed.”
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ETextRx White Paper
The Extraordinary Problem of Medication Nonadherence in Oncology Patients And How Digital Pills Can Make a Difference
Cancer is often highly treatable due to new therapies, especially oral agents, that have improved outcomes and survival rates, and allow patients to be treated outside the hospital setting. Yet many patients fail to take their medication consistently, despite the potentially dire consequences of not adhering to the prescribed oncology treatment plan. Nonadherence or suboptimal adherence to cancer treatment regimens must be identified early to optimize outcomes. An accurate, safe, and reliable system that patients and clinicians will trust and use can help to get cancer patients back on track.
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Within3 White Paper
How Life Science Companies Can go Stakeholders With a Hybrid Virtual Approach
The COVID-19 pandemic forced life science companies to move many core operations to virtual meetings, from clinical trials to employee training. With an end to the pandemic in sight, many clinical operations teams may wonder whether some of the virtual practices and technologies they’ve adopted should permanently be part of doing business. For most types of work, a hybrid approach combining the best elements of virtual interaction – live and asynchronous – can create efficiency gains and enhance communications across a range of functions in life sciences. Download this white paper to learn more about: The trend towards asynchronous (over-time) virtual goment; the benefits of a hybrid virtual platform to improve communications and efficiency; and
how various pharma functions are improving operations with a hybrid virtual approach.
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Appian White Paper
Achieve Operational Excellence Throughout the Product Lifecycle
Developing, distributing, and monitoring a drug or medical device is an extensive process involving the coordination of people, systems, and substantial amounts of data. Production slowdowns negatively impact the product lifecycle, adding unnecessary costs and keeping valuable products from patients who need them. As industry struggles with inefficiencies and seeks process improvements to better deliver patient value, there’s been a new push for operational excellence. How can organizations achieve operational excellence and deliver the best value to patients? Streamlining end-to-end processes throughout the product lifecycle is the key.
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Framework Solutions White Paper
Establishing a Content Management Process as a Late Stage Company
Due to evolving regulations governing the pharmaceutical industry, expanded use of social media platforms to communicate
key milestone data, and the shift in how content is being utilized, late stage companies have benefited from establishing Content
Management Processes earlier in the drug development lifecycle. This shift has led to the wide-spread adoption of best practices as companies look to harmonize their Content Strategy with their people, process and technology. This white paper provides the reader with a clear understanding of evolving best practices and trends as to how to create a Content Strategy that lays the foundation for the Content Management Process.
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Larvol White Paper Podcast
AI-Assisted Tools for Monitoring Precision Medicine Predictive Biomarkers Landscape
Predictive biomarkers, biological characteristics which identify individuals more likely than others to favorably respond to a therapy, are helping to improve accuracy in precision medicine. “Our database creates a detailed real time platform of reliable insights on biomarkers and biomarker activity, used primarily to stay up to date on cancer biomarkers, and to understand the extent to which they're predictive of drug response,” explains Sabrina Bellisario, Director of Operations, Larvol. “Our newest endeavor is to apply artificial intelligence and algorithmic approaches to actually predict new areas of research for particular biomarkers, drugs and tumors,” continues Larvol Director of Oncology Mark Gramling.
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Cerner White Paper
Leveraging the EHR to Revolutionize Research
The current clinical research enterprise is slow, siloed, inefficient and costly. Translating research into practice is similarly slow and inefficient. Aggregated, standardized, person-centric electronic health record (EHR) data is now available to help provide the needed research-ready data to help power clinical research. A novel, nationwide Cerner Learning Health Network 5M (LHN) has launched that leverages the EHR and a cloud-based data platform to power clinical research across a collaboration of heterogenous health systems.
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ACRO White Paper
Decentralizing Clinical Trials: A New Quality-by-Design, Risk-Based Framework
Innovations in clinical trial design are leveraging emerging mobile technologies and increased connectivity to transcend some limitations of conventional trials by incorporating decentralized, patient-centric approaches. Because of their expertise in clinical trial innovation and clinical trial technology, the clinical research and technology companies of the Association of Clinical Research Organizations (ACRO) have paved the way in designing, executing, and refining decentralized clinical trials (DCTs).
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Indegene White Paper
From Aspiration to Action: Embracing a Customer-Centric Mindset in Medical Affairs Through Digital Transformation
A wealth of data exists around customer experience and digital transformation, but only a few papers focus on the pharmaceutical industry or specifically Medical Affairs. That is why the Medical Affairs Digital Strategy Council has developed tangible and solution-oriented insights on how to embrace a customer-centric mindset driven by digital transformation to improve customer experience. Although Medical Affairs gos with multiple customer groups, this white paper focuses on the customer experience of healthcare professionals.
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Covance White Paper Podcast
Drug Adverse Event Reporting During COVID-19 Lockdown
The global COVID-19 pandemic has brought new urgency and challenges to reporting drug adverse events in clinical trials and the consumer market. "It may well be the case in the months to come that we learn of adverse events which took place during the lockdown but which are only reported at a much later stage," suggests Dr. Thomas Leigh, an Executive Medical Director and Head of the Medical Group within Patient Safety Solutions & Adjudication for Covance. "The pandemic and its effects are significant, and it will be very important for all of us involved in the assessment of safety of medicines to look out for evidence of safety events which perhaps have not previously come to light."
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Covance White Paper Podcast
Automation Improving PV Quality and Compliance
“Safety case processing is probably the largest bundle of effort in a PV department, and some of these robotic and cognitive automation tools today are allowing us to reduce the effort it takes to process a case while also improving both quality and compliance,” explains Dinesh Kasthuril, Director of Client Services, Covance Patient Safety. “When something like cognitive automation can be combined with robotic process automation, we’ll see significant savings and efficiencies.”
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DIA & Salesforce White Paper
Keeping R&D Data and Regulatory Approval Processes Advancing in Alignment
In an era of expiring patents, spiraling costs, and increasing competition, effective therapies must be developed more quickly and efficiently than ever. This white paper examines how pharmaceutical and other life sciences organizations can keep critical data, R&D, and regulatory approval processes advancing in alignment.
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Bayer White Paper
A Grassroots Approach to Creating a Patient goment Movement
Harnessing the passion of employees to involve patients in a meaningful way throughout the drug development process ensures their voices are heard and enables the co-creation of solutions that address patients' needs beyond their symptoms and disease experience. To learn more, download Bayer's white paper on its all-inclusive "Patient Insights & goment" network.
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Rho White Paper
Right-To-Try or Right-To-Ask?
Programs providing seriously ill patients with early access to investigational products are of great interest to the public, but what are the implications to pharmaceutical and biotechnology product companies? This article examines Right-to-Try legislation as well as FDA’s existing expanded access programs from the perspective of companies who are considering providing investigational products to patients with serious or life threatening diseases that have exhausted all other treatment options.
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DIA & Vifor Pharma White Paper
Nanomedicines & Nanosimilars: Implications for Regulators, Payers, and Prescribers
Nanotechnology is a dynamic and evolving scientific field that presents numerous opportunities for forwardthinking developers to create innovative new medicines to address unmet needs, improve diagnostics, and unlock the potential of regenerative medicine. Dozens of nanomedicines are already in clinical use globally, and advances in nanotechnology are contributing to an increase in academic- and industry-led research directed toward developing new nanomedicines for a variety of therapeutic areas.
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Rho White Paper
Seven Essentials for Successful Drug Development
In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. Although all are largely within control of developers, many are often inadequately considered or overlooked. There is no doubt that many companies work diligently to design and conduct only the most scientifically sound clinical studies. The goal of this paper is to remind us of the importance of these essentials so that effective therapies have a greater likelihood of reaching patients.
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DIA Regulatory Affairs Community White Paper
RIM Framework Interim Consensus Paper
The Regulatory Information Management Working Group (RIMWG) of DIA’s Regulatory Affairs Community has identified potential benefits that could be captured from the development of a conceptual framework for Regulatory Information Management (RIM). Such a framework would aid organizations in structuring the complex organizational, informational, and technological issues germane to RIM’s myriad of challenges related to cross-functional global data identification, ownership, quality management, and maintenance. This Consensus Paper chronicles the RIMWG’s discussions, debates, feedback, and decisions made by global RIM stakeholders during framework development.
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Appian White Paper
Next Generation Technology is Driving Life Sciences Innovation in R&D
While advancing medical treatments worldwide, the rapid pace of innovation in the healthcare sector has brought about cost and productivity challenges for the pharmaceutical and biotech industry. Life Science organizations are faced with steadily rising research and development (R&D) costs and an increasing squeeze on revenues. For R&D productivity to increase it will require shorter and more cost efficient processes that integrate information, knowledge, and resources along the medical product development chain while keeping a close eye on the value to patients.
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Indegene White Paper
Intelligent Content Authoring in the Medical Domain
Throughout the drug development process and lifecycle management, digital content is “created” and “consumed” by various cross-functional departments like regulatory, safety, medical, or clinical. The absence of a homogenous platform often leads to delay in bringing the right information to the right person at the right time. Intelligent content authoring (ICA) involves creation of a fully indexed knowledge base derived from source documents, and helps ensure faster time-to-agency, faster time-to-market, and exceptionally high gains in productivity and efficiency in developing medical content.
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ICON White Paper
Special Report: Disruptive Innovation - The Impact
The number of companies working on disruptive innovation has increased substantially over the past few years and investment in this sector is massive. Pharmaceutical companies and CROs need to change how they look at everything they do across the entire spectrum of drug development. By adopting disruptive innovation, interventions can be made at each stage of the clinical development process to radically change and improve the way clinical trials are designed and conducted, to the benefit of the industry and, most importantly, patients.
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PAREXEL White Paper
CAR T-Cell Therapies Pose a New Development Model and Demand New Skill Sets
After two chimeric antigen receptor (CAR) T-cell therapies won FDA approval in 2017 to treat children and young adults with acute lymphoblastic leukemia (ALL) and adults with diffuse large B-cell lymphoma, the American Society of Clinical Oncology hailed CAR T-Cell Immunotherapy as the Advance of the Year. More than 100 companies are now working on CAR T-cell therapies—primarily for hematologic cancers, but also for certain solid tumors—and there has been an explosion in the number of clinical trials registered each year. However, few companies possess all the necessary in-house skills to develop CAR T-cell products.
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Sciformix White Paper
Real World Evidence (RWE) from Clinical Development to Patient Access
Value based payment (VBP) has emerged as an effective strategy to promote the quality and value of medical products, devices or health care services. The goal of any VBP program is to shift from pure volume-based payment, to payments that are related to the desired health outcomes. The transition to VBP has underscored the importance of Real World Evidence (RWE) as a radical approach to bridge the evidence gap for medical products and devices.
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PAREXEL White Paper
Recalibrating Regulatory Strategies to Leverage Evolving Accelerated Pathways in the US and EU
As the push for faster, smarter approvals fathers speed in the US and EU, accelerated pathways (APs) for drug development are evolving. This shifting landscape presents companies with opportunities (streamlined development, more regulatory advice, faster times to market) and risks (smaller clinical data sets, rapidly changing science, reimbursement hurdles). It will require agility and flexibility to reap the benefits while avoiding the pitfalls.
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Saama White Paper
Enterprise Data Analytics: A Competitive Weapon for Life Sciences Companies
Almost all organizations in the pharmaceutical industry are facing increased competition, tighter regulations, shrinking budgets, and similar challenges. Organizations are beginning to realize that they can leverage their data assets to help resolve some of these issues. Leveraging data for analytics to gain actionable business insights is just the next natural progression. This White Paper delves into the changing world of data, technology, and business, to explore the DNA of a future-ready, cloud-centric data analytics enterprise solution.
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G&L Scientific White Paper
Global Trends in the Regulatory Affairs Landscape
Driven by a growing need to reduce costs, cut overheads, increase productivity, scalability and flexibility, outsourcing key regulatory and clinical functions is now commonly viewed as a long-term strategic partnership. Long perceived as a cost-effective solution to managing regulatory budgets, the use of off-shoring locations is now coming under increased scrutiny and its “real-world” cost-effectiveness is being questioned.
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Saama White Paper
Clinical Data Analytics: Disruptive Technology on the Horizon
The amount of data that is generated in life sciences and health care industries is almost incomprehensible. This paper looks at the root cause of the challenges related to data analytics across these industries and explores available clinical data analytics solutions and their viability. After all, for any pharmaceutical company, data is the foundation on which the future success of their business rests.
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Sciformix White Paper Podcast
Quality Adjusted Life Year (QALY)
Health economics plays a crucial role in informing healthcare resource allocation decisions for the reimbursed markets, explains Madhur Garg, Director, Real World Evidence and Market Access, Sciformix Corporation. Health technology assessment (HTA) is often applied to assess the affordability and value of new healthcare technologies like drugs, medical devices, diagnostics, etc. QALY is often employed in the HTA process to quantify and compare health benefits of various treatment options. QALY is a measure of quality and quantity of an individual’s health state and is commonly used in health economics and outcomes research (HEOR).
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OM1 White Paper
From Big Data to Measurable Outcomes: Aligning Stakeholder Needs for Value Based Contracts
Pharmaceutical companies and payers typically have several goals when considering an outcomes-based contract. For pharmaceutical companies, goals may include improving a drug’s position on the preferred drug list of a health plan, accelerating the availability of new treatments on a formulary, reaching an agreement on a reimbursement framework when some longer-term benefits are still unproven, and getting drugs to the market more quickly. For payers, costs are a primary concern, particularly for high-cost new therapies that are unproven in the real world. Payers are also interested in improving allocation of resources towards their members most likely to receive benefit.
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RxSolutions White Paper
Creating a New Standard in Simplifying and Reducing Costs in Clinical Supply Efforts
Supply chain efficiency in the conduct of clinical studies is a critical factor determining part of the overall cost. When appropriate, unblinded clinical study supply optimization can save time and resources and decrease risk by providing a more efficient end-to-end process. The RxStudy Card™ is a sponsor-funded program that allows subjects to acquire their unblinded clinical study supplies through the pharmacy network at no cost.
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Sparta Systems White Paper
Leverage Your Quality Management Software Across Laboratory and Clinical Trial Drug Development
This white paper from Sparta Systems explains the demands of quality management in the preclinical and clinical stages of drug development, the challenges quality assurance professionals and auditors face when managing clinical quality manually, and technology available to automate processes, streamline workflows and increase visibility for greater efficiency, accuracy and safety.
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Sciformix White Paper
Sciformix Accelerator Methodology Delivers Validated Oracle Argus Cloud in Record Time
Due to various reasons, clinical and post-marketing safety data and information are often housed in disparate and/or legacy systems. This makes it difficult to access and view data, make informed decisions, and manage reporting to regulatory authorities. In addition, safety data is managed at different levels of effectiveness, which results in a lack of control. Organizations look to implement a consistent, validated, and secure Best-of-breed safety solution, yet oftentimes they don’t have the resources (money, expertise, etc.) to maintain the infrastructure in-house. The Sciformix Accelerator Methodology can be used to implement a validated, compliant, secure and hassle-fee Oracle Argus Cloud safety solution in record time.
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Lionbridge Life Sciences White Paper
Launching Global Clinical Trials: Best Practices for Efficient and Cost-Effective Translations
The target market for conducting global clinical trials has changed significantly, moving beyond pharmaceutical early adopters to the mainstream marketplace. More and more companies are moving toward ascending regions, such as India and China, to launch global trials, and are naturally looking at the downstream benefits these locations offer. This focus on end-benefits, however, fails to consider the deep challenges of the launch process, and companies who are not yet globally-proficient are likely to underestimate the critical role that translation plays in that effort.
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CRF Health White Paper
Electronic Clinical Outcome Assessments (eCOA): An Introductory Guide
A clinical outcome assessment (COA) measures a patient’s symptoms, as well as his or her mental state, or the effects of a disease or condition on a patient. Some are unobservable concepts, such as pain intensity, moods or feelings, and eating habits. Electronic clinical outcome assessments, or eCOAs, employs technology such as smartphones, tablets, and personal computers to allow patients, clinicians, and their caregivers to directly report outcomes.
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Schulman IRB White Paper
Speeding Study Start-Up in Multicenter Clinical Trials
Managing an efficient, well-organized start-up phase is critical to overall study success. While IRB review is just one element of the study start-up process, the IRB can play a crucial role in reaching key study milestones in multisite clinical trials for sponsors, CROs, and research sites. By partnering early and communicating openly with your IRB, researchers and study sponsors can see a significant reduction in time spent on the initial IRB review process, which can influence and improve overall study start-up timelines and success.
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Patient Focused Medicines White Paper
Collaborative Patient goment: Mapping the Global Landscape
Despite the substantial increase in patient goment (PE) initiatives, there is currently no efficient mechanism for accessing information on what PE activities are ongoing or planned and to identify challenges encountered and lessons learned. An essential first step in developing a meta-framework is to identify and “map” existing initiatives and frameworks, allowing a 360-stakeholder view of the PE landscape. This will provide a platform for identifying gaps and synergies from different stakeholder perspectives and allow those committed to effective PE to learn from good practice by actively sharing experience and to connect.
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Sciformix Whitepaper
Smart Sourcing Strategy: Vendor Selection for Safety & Risk Management Support
Strategic planning, sourcing, and implementation of safety and risk management operations are multi-dimensional activities that require consideration of a multitude of factors. Compliance, quality, and efficiency of safety processes being outsourced is a basic expectation now for more tactical areas of pharmacovigilance (PV) such as call center and case processing due to the maturity of the outsourcing and offshoring environment and processes. This trend has helped sponsors to focus their in-house resources on the strategic elements of safety and risk management while leveraging the service provider’s capabilities.
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DIA-TOPRA White Paper
Report from DIA-TOPRA Adaptive Pathways Workshop: EU Adaptive Pathways: Ultimate Success Will Depend on Industry-Payer Communication
Timely authorization of products expected to cover unmet or high-impact medical needs is vital to support innovation and to improve patient access. The introduction of adaptive pathways is challenging but initiatives such as the EMA adaptive licensing project and recognition of the issues around HTA approval for conditionally-approved products in the EU are helping shape the regulatory framework. The DIA-TOPRA Adaptive Pathways Workshop, June 2015 in Brussels, Belgium, considered how the regulatory hurdles to bringing such products to market could be overcome in order to improve patient access to vital new treatments.
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Clinical Ink White Paper
eSource: Reducing Site Workload for Better, Faster, Safer Clinical Trials
Life science companies are under increasing pressure to execute clinical trials faster with higher quality. As a result, more sponsors and CROs are looking for new ways to better leverage investigative site relationships to improve clinical trial performance. To this end, some clinical organizations have adopted electronic source (eSource) to help improve study quality and efficiency - for both sponsor and site. Unlike traditional electronic data capture (EDC), Clinical Ink's eSource platform SureSource was designed to minimize clinical trial complexity for site users. Clinical Ink's Site Impact Survey provides scientific evidence regarding the impact of SureSource from 517 site users. Results confirm that SureSource significantly reduces workload, lessens queries, and improves data quality compared to paper and EDC.
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Wincere White Paper
Compliance for Mobile Medical Apps
There is not yet a single device that can diagnose, monitor, and treat a patient for every type of health problem without even making physical contact or directly interacting with body molecules. That’s still something of a holy grail in the medical device industry. What we have instead is the birth of the first generation of a new species, burst from the womb of rapidly evolving technology; tens of thousands of medical devices and mobile apps designed for uniquely specific purposes; all working together to lay the collective foundation for what could one day be the ultimate medical utopia. But without discipline, all this forward momentum is for naught. As tempting as it is to run wild with ideas and succumb to the raptures of pure creativity, progress must be tempered by responsibility. Chaos benefits no one.
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MediciGlobal White Paper
Clinical Trial Retention Meta-Analysis: Subjects that are actively or passively enrolled into clinical trials are retained differently
Patient recruitment methods can have a significant effect on the retention of subjects in clinical trials; these effects can result in considerable cost implications. Subjects that actively sought clinical trial involvement through an online pre-screener (in response to online clinical trial advertising) using the Medici Global model, showed 38% lower relative risk of drop out across four studies compared to those who were recruited by sites, with divergence across visits in all four studies. Since increasing sample size is typically associated with an increase in the statistical power of the study, the loss of subjects over the course of a trial can result in missed endpoints and negatively impact the outcome of the study. Engaging subjects that actively seek clinical trial participation results in a reduction of study withdrawals or patient dropout rates; the effect of which eliminates the need for over-enrollment of patients to offset expected retention loss. Increased retention rates accelerate enrollment timelines and result in saving time and money.
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CenterWatch White Paper
New Gains Seen from Patient- and Site-Centric Initiatives
Relationships between drug sponsors and investigative sites have become more effective during the past two years, according to a new CenterWatch survey, as the initiatives top sponsors have implemented in recent years to address site burdens - such as increased protocol complexity and insufficient study support - are beginning to have a positive impact. Significantly, the 2015 CenterWatch Global Investigative Site Survey marks one of the few times in almost two decades that the industry has seen such strong improvement in sponsors narrowing the performance gaps across the attributes sites rate as most important in defining an effective relationship.
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