Blog posts

Medable Petitions Comments on ICHE6(R3) Draft Guidance

When technology enters a regulated environment, early adopters often cite regulatory uncertainty as a hurdle. In fact, a 2021 Clinical Trials Transformation Initiative (CTTI) survey showed that regulatory uncertainty and lack of harmonization were the top reasons that hindered adoption of elements of decentralized clinical trials (DCTs). 

During the COVID-19 pandemic, the increased adoption of decentralized methodologies was guided by temporary guidances put out by many regulators such as FDA’s March 2020 “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency” and the corresponding EMA guidance, which explicitly mentioned it would expire at the end of the designated Public Health Emergency. 


Strategies for implementing eConsent across the European regulatory landscape

Camila Matheny, EVP of DCT Offerings at Medable and Caroline Beaufour, PharmD, Ph.D., Innovation Lead, Clinical Development Support at Servier, dive into the intricacies of implementing electronic informed consent (eConsent) in clinical trials within the complex regulatory landscape of European countries.

Blog posts

Medable perspective: Three points on FDA eCOA guidance

At the beginning of April 2023, the FDA published a draft of the fourth in a series of Guidance Documents entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints For Regulatory Decision-Making”.  Once finalized these four documents will be combined and will replace the 2009 Guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”.  Part 3, which was released in draft in June 2022, provides advice around the development and validation of new COA (including the modification of existing COA).

Blog posts

Podcast: Michelle Longmire and David Fajgenbaum of EveryCure join the PharmaExec podcast

Medable CEO Michelle Longmire and Dr. David Fajgenbaum, co-founder of EveryCure, join Pharmaceutical Executive podcast to talk about their partnership adn navigating the regulatory landscape.  

Blog posts

J.P. Morgan Week 2023: Trends, highlights, and themes from this year’s conference

See what key trends and takeaways were at the 2023 JPM conference and how they'll drive the landscape of pharma.

See how Medable can make your trials more efficient.