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The beginning of November saw the launch of version 3.2.0 of the TMF Reference Model. The updates align with current regulatory guidance and industry best practices, making it easier to organize the TMF Reference Model to suit a company’s own processes.
The 2020 9th Annual TMF Summit placed proper emphasis on these three pillars of TMF management: Quality, Completeness, and Timeliness (real-time inspection readiness). Interestingly, 60% of attendees polled reported they were more concerned with completeness than quality.
The reasons given were:
In part 1 of our vendor oversight series we talked about managing trial master file (TMF) vendors. In practice, this is just one of the many variations of risk management across a clinical trial.
Recently, TransPerfect’s Trial Interactive E-Clinical Innovation EU team attended the GCP and Inspection Readiness Conference in Brussels. The focus of this conference is critical: Sponsors must be ready to reconstruct the entire “story” of a clinical trial through timely and comprehensive reporting and documentation.
I don’t know about you, but when I look at the costs associated with the drug development lifecycle, I can’t help but be astonished. Recently, I read that the cost of developing a new drug and bringing it to market is estimated to be more than $2.5 billion, not including the costs involving post-approval development. It is no small feat to bring a treatment to market.
Have you ever followed a recipe from a cookbook or your favorite foodie site and wowed family, friends, house guests, and/or complete strangers? Have you ever rushed through a recipe only to realize you’ve skipped steps and missed important details in the process? You probably ordered a pizza that day and spared your guests.
After attending a recent developer conference for one of our vendors, the topic of serverless technology came up again and again.
The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) compliance in reaction to Trial Master Files (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.”
