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White Papers

What is a White Paper?

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

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.

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.”

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.”

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.

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.

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.

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.

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.

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.

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.”

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.

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.

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.”

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.

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.

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.

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.

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.

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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