Whitepapers

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.

What if you could predict potential safety issues before clinical development begins? Innovative new signal detection and management approaches have been developed to help clinical trial sponsors, manufacturers, and CROs combat safety-related challenges and provide insight to be used to predict potential safety issues even before clinical development begins. Applying those learnings to their choice of initial research candidates can ultimately mean safer medicines for patients.

The cost and benefits for patients and sponsors in using ePRO versus paper

Site augmentation helps expedite COVID-19 vaccine trial by enrolling over 30,000 study participants in just over three months. 

Download this report to learn how the COVID-19 pandemic impacted the future of the clinical research workforce.

Download this report to learn how the COVID-19 pandemic impacted the future of the clinical research workforce.

Download this report to learn how the COVID-19 pandemic impacted the future of the clinical research workforce.

“If it’s not documented, it didn’t happen.” This is a well known saying to Quality teams in biotechnology. What it means is that every step in the development, clinical, and manufacturing processes needs to be documented or else regulators can’t accept that it happened. In the eyes of the FDA, without documentation, the research, the clinical trials, or the manufacturing process needs to be repeated. This results in added expense, costly delays, and an erosion in trust from regulators, investors, and consumers. In this piece, Egnyte chronicles the nine elements that successful Quality & Compliance teams adopt to keep pace with the speed of discovery. Learn the best practices for an effective quality documentation process.

Drug development has dramatically changed over the past ten years. Specifically when it comes to GxP compliance and validation. Many biopharma companies struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. In this white paper, Egnyte will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

As life sciences companies grow, the regulatory compliance requirements and risks expand as well. These responsibilities extend beyond conventional health-related frameworks (e.g. GxP, HIPAA, etc.) into the realm of data privacy. For high-growth institutions with limited resources & bandwidth, the question arises: what should you do? In this document, Egnyte chronicles some of the regulations affecting the life sciences industry and share 5 activities to help your organization comply with these new and dynamic laws.

Recently there has been an increase and awareness of the long-standing problems with diversity and the inclusion of under-represented populations in clinical research.