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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.”
