Innovations in technology, economics, policy and scientific discovery occur with such frequency and speed in the fast-changing, hypercompetitive world of life sciences that only the most versatile and far-sighted pharmaceutical and biologics companies can thrive. In a new white paper, Patricia Santos-Serrao, RAC, MasterControl’s director of clinical and regulatory solutions for pharmaceutical, blood, and biologics, sheds light on the top five clinical trends that are sure to have a massive impact on the pharmaceutical and biologics sectors this year.
The paper is drawn from Santos-Serrao’s deep clinical knowledge as a member of the Regulatory Affairs Professional Society (RAPS) and the Drug Information Association (DIA) and more than two decades of professional experience in the regulatory affairs and clinical areas of the pharmaceutical industry. In it, she provides details about recent important clinical and regulatory developments and illustrates how companies can adapt to challenges by making fundamental adjustments to the way they manage clinical research and trials.
The following is a brief rundown of several of the major clinical trends highlighted in the white paper. For in-depth analysis of all five of the major clinical pharma/bio trends to watch in 2018, download the white paper.
Regulatory inspectors are increasingly requesting direct access to trial master file (TMF) documentation during inspections and clinical study audits. This is due in large part to the recent updates to the ICH GCP E6(R2) guideline that address essential documents in clinical trials. Since the amended guidance mandates that documents that are essential to a clinical study “may be subject to, and should be available for, audit by the sponsor’s auditor and inspection by the regulatory authority(ies),”[i] TMF inspection readiness has soared to the top of the priority lists of clinical organizations that hope to maintain regulatory compliance.
The most significant hindrances to TMF inspection readiness arise when clinical documentation is managed in siloed, predominantly paper-based systems that impede study teams’ access and lack a means of accurately measuring status and performance. To counteract these barriers to inspection readiness, Santos-Serrao recommends the implementation of an electronic system expressly designed for TMF management. Specialized eTMF systems provide a variety of benefits, such as: