Whitepapers

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.

Learn about how sponsors and sites can identify and overcome barriers to participation and implement strategies to diversify their clinical trials.

Read this whitepaper to learn about key considerations pharmacovigilance teams examine when evaluating new safety solutions. 

Watch and learn how The McCreadie Group and endpoint experts offer a solution to the current struggles IDS sites and sponsors have been facing.

endpoint’s VP, data and Quality, Cat Hall shares key questions you might be missing that help ensure your IRT provider is focused on quality first.

This session, led by endpoint’s VP of Data and Quality, Cat Hall discusses how efficient clinical trial design strategies that expedite the development of oncology drugs and biologics are necessary.