How Decentralized Trials Accelerate Research and Enable Diversity
August 3rd 2022Decentralized 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.
Risked-Based TMF Quality Review: A Success Story
July 26th 2022A 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.
5 Reasons Your TMF Isn’t Inspection-Ready
July 20th 2022Ensuring 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.
Tissue IHC: Translating Technology into Patient Testing After Biomarker Target is ID
June 8th 2022In 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?
Breaking down the basics of decentralized clinical trials
May 11th 2022Browse 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.
Tips for tailoring eConsent for Optimal Patient Centricity
May 11th 2022Informed 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.
The Next Domino: Automation, AI, and touchless safety case processing
February 15th 2022With 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.
Smarter Signal Management: AI, big data, and predictive analytics
February 15th 2022What 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.