05.11.21 Clinical Trial Software And Service Partners Ready To Help
With the exponential number and increasing complexity of clinical studies now being run the paper-based informed consent process is inherently inefficient. Rave eConsent is an innovative, patient-friendly, electronic informed consent and patient enrollment system for clinical trials.
Our industry is now, more than ever, ready to move to decentralized trials (DCT) and design hybrid protocols that support trial continuity and have a more patient-centric approach. Most sponsors have struggled to implement DCT and need an innovative, modern technology platform that enables more efficient and future-ready trial processes. The unique architecture of encapsia brings the technology to the data and provides an agile, revolutionary way to support decentralized clinical trial.
10 Things You Should Know About The New TMF Regulatory Guidance
The new European Medicines Agency (EMA) guidance on Trial Master Files – “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)” – took effect on June 6, 2019. This major guidance will have a significant and far-reaching impact on your organization’s TMF processes, technology, and best practices – as well as related departments and systems.
The good news is that the new EMA guidance forms the most detailed guide to TMF best practices yet published by a regulatory agency, and in fact is becoming a de facto industry standard. Based on Phlexglobal’s extensive experience helping organizations successfully pass hundreds of regulatory inspections, following are 10 key developments that you should be aware of.