Features

Electronic Storage of Work Correspondence – GCP Questions, FDA Answers

March 19, 2018

FDA regulations provide guidance for the handling and storage of electronic records, including email. The regulations do not, however, provide answers for every possible question. FDA’s Office of Good Clinical Practice responds to questions from the public interpreting FDA’s position, offering advice on how to proceed and pointing out key documents and resources that provide more guidance. The following question and OGCP answer regarding the electronic storage of correspondence comes from their website.

Small Biopharma Companies Must Wrestle With Big Safety Data Responsibilities

March 19, 2018

It used to be relatively straightforward to aggregate all safety data from a compound’s trials and send it to the FDA annually, as required. As the sponsor, you either had the data within easy reach in your files, or the one or two CROs you’d outsourced to could easily pull it together. It was simple.

Tufts CSDD: Clinical Trial Startup Process Takes Longer Than 10 Years Ago

March 12, 2018

The process of selecting clinical trial sites and launching studies, beginning with site identification and ending with study start-up completion, takes an average of 31.4 weeks for Phase II and III studies — a full month longer than the average seen 10 years ago, according to a survey conducted by the Tufts Center for the Study of Drug Development.

Free Online Transparency Tool Tracks Clinical Trials Reporting Compliance

March 5, 2018

The FDAAA TrialsTracker, an online tool that charts whether individual sponsors report their study results on ClinicalTrials.gov in compliance with federal laws and regulations, launched Feb. 19. The data transparency project was developed by the University of Oxford’s Evidence-Based Medicine DataLab, and is available to the public.

Early Chart Reviews Can Provide Steady Flow of Potential Study Subjects, Experts Say

February 26, 2018

Beginning chart reviews before initiating a site can generate a list of prequalified candidates for outreach — and give sponsors the chance to examine the study’s inclusion and exclusion criteria, and their potential to cause enrollment issues, according to experts during two WCG webinars on acceptable methods for sites and sponsors, and best recruitment practices.