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
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 engages 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 Engagement 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 & Engagement" 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 Engagement: Mapping the Global Landscape
Despite the substantial increase in patient engagement (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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