Whitepapers

Curious about mRNA technology and the regulatory requirements for its use in clinical trials? Advarra’s gene therapy research experts respond to commonly asked questions.

How can you tell if your study requires IBC oversight? Start with these common terms found in research protocols requiring IBC review.

Whether used exclusively or as part of a hybrid approach, patient-centric decentralized clinical trial methods enable investigators to more easily recruit and retain a diverse patient population. DCTs cannot, however, yield their full spectrum of advantages without proper planning and attention to detail. This checklist can help guide sponsors and CROs toward a successful trial.

There is a growing body of evidence that hybrid and decentralized clinical trials are here to stay. What was once a nice-to-have is quickly transforming into a must-have. The catalyst for this dramatic shift was the COVID-19 pandemic. To aid sponsors and CROs in fully realizing the benefits of decentralized clinical trial methods moving forward, this whitepaper extracts the lessons learned from the pandemic and their implications for clinical trials now and in the future.

Today, we live in a world where we have the capability to reach anyone, through decentralized clinical trial techniques and we have an ethical obligation to implement them.

In this whitepaper, Science 37's Diversity & Inclusion leaders share strategies on how to achieve diversity in clinical trials in order to adhere to the FDA's Guidance.

Decentralized clinical trials are not an all-or-nothing approach, they encompass a spectrum of hybrid designs that when implemented correctly deliver transformative results.  In this white paper, Science 37 leaders discuss where decentralized research is now, and where we are headed. Experts unveil new—and proven— models and the benefits they deliver, from accelerated patient enrollment and improved experience to real-world representation.

A biopharmaceutical company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. Only later did they discover that the Trial Master File documents were scattered across hundreds of boxes of paper and several hard drives. The company was facing critical submission deadlines and the risk of losing financial incentives related to the product acquisition – with zero insight into potential TMF quality and completeness issues that could lead to a failed inspection and delayed submission. Read the case study, “From Liability to Asset: A TMF Rescue” to discover how Phlexglobal’s unique blend of TMF expertise and services turned a “black box” into an inspection-ready TMF – ahead of schedule.

Ensuring ongoing inspection-readiness of a Trial Master File can present challenges to even the most well-prepared organization - with unforeseen quality or completeness issues cropping up when least expected. To help identify and avoid the most common errors, Phlexglobal’s TMF experts have compiled a handy guide, “5 Reasons Your TMF Isn’t Inspection-Ready (and what you can do to fix it).” You’ll discover the top causes of inspection findings, as well as pragmatic steps to improve inspection-readiness. Want to reduce the uncertainty and risk of an inspection, and be better prepared to pass this critical test when it happens? Download the helpful guide today.

Explore how an integrated approach to the clinical research industry’s technology landscape can remove friction, improve access and diversity, save time, and better serve patients.

In the discovery and investigation of novel biomarkers, tissue immunohistochemistry (IHC) studies are critical, but how do you translate the technology into the clinical laboratory for patient testing once a biomarker target has been identified?

How the industry has changed and what can be expected today

Catherine Hall, VP Product Strategy at endpoint Clinical tells the story of the past of Direct-to-Patient (DTP) logistics and speculates on the future of DTP, and Virtual, Decentralized, and Hybrid clinical trials.

Browse your email, attend a conference or read a journal and you are bound to see terms like ‘digital health’, ‘virtual’, and ‘decentralized clinical trials’. What is all the buzz? Recruitment, retention, diversity, efficiency, safety and accuracy are all factors driving the need for radical innovation. This need is painfully apparent during the current COVID-19 pandemic. We can no longer ‘do the same thing and expect a different result’; it is time to take some giant steps forward.

How to create a seamless experience across eConsent, eCOA and more. Read our whitepaper to learn more!

Informed consent used to take place on lengthy, hard to comprehend paper consent forms, during inperson for patients who were within travel distance to a physical site. Today, we have an easier, more accessible solution called eConsent. Optimize patient access to clinical research with a modern eConsent platform that delivers an engaging, flexible and scalable user experience.

Reduce your Clinical Study Budget by as much as 55% with a CEE based CRO: Whitepaper by Research Professionals CRO.

With the increasing volumes of adverse event reports and stagnant budgets, the time is now for a revolutionary change in drug and device safety case management. A robust management process is necessary for identifying and evaluating adverse events (AE) and reporting them properly to regulators.