Clinical trials are complex, but adding genomics to the equation has the potential to make them even more complicated. However, much of the genetic testing that is now being performed in the clinical space is done before a trial begins. That means companies need to do some thinking before adding a genetic test to the protocol.
This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.
This is part 2 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.
I was recently invited to speak on the subject of fraudulent candidates and fake clinical research associates (CRAs) at the Global 2018 ACRP Conference and was astonished at how many hiring managers were not aware applicant fraudulence exists.
A summary of the clinical relevance of RNA-Seq as well as when and how to use gene expression profiling for biomarker discovery for immunotherapy trials.
Late Phase Research in the Life Sciences segment is undergoing a rapid transformation due to the digitalisation of healthcare and the greater availability of, and access to, Real World Data (RWD). This transformation is arriving not a moment too soon, given the changes anticipated from the Twenty-first Century Cures Act, EMA’s Adaptive Pathways approach, and the increased demand for Real World Evidence (RWE) generated from these RWD. In addition to supporting regulatory decisions, RWE is playing an ever expanding role in developing the product value propositions that are driving reimbursement decisions globally.
Immune repertoire profiling provides better outcomes for immuno-oncology development programs .
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Representatives from research institutions, industry, and FDA discuss guiding principles regarding the selection of adequate RWD sources and appropriate study designs within the regulatory context.
Experts from the realms of regulatory affairs, venture capital and industry discussed the FDA Commissioner’s impact on, and new opportunities for, industry-agency collaboration in the development and regulation of innovative new therapies.
The “International Regulatory Convergence” DIAmond session brought together representatives from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and Health Canada to discuss how regulatory agencies seek to set strategic goals and priorities for various collaborative regulatory initiatives addressing AMR.
Since the launch of myTI—TransPerfect’s mobile experience for the Trial Interactive eTMF—I have heard rave reviews from clinical operations leaders and CRAs. The advantages of mobile technology for clinical operations are generating a lot of excitement, and rightfully so. In my collaboration with study teams during the development, release, and ongoing evolution of myTI, we encountered many thematic pain points that were ripe for a mobile solution.
An overview of the progress that has been made in pediatric drug development.
