Castor

EU MDR is turning PMCF from a checkbox into a real operational challenge. Device teams need compliant post-market evidence collection without burying sites in paperwork. 370+ medical device teams run PMCF on Castor, including the MMI PRIMO study, which saw a 520% enrollment increase. Read the brief to see how it works.

Patient organizations aren't waiting to be consulted. Some are now driving the drug development agenda. Join Craig Lipset and Dr. Derk Arts on September 17th to explore what this shift means for sponsors and the future of clinical research.

The hype period is over. Direct-to-patient clinical research has moved from emerging trend to proven strategy. The question now is execution. On Wednesday, September 9th, Tyler Van Horn (CEO, Science 37) and Jane Myles (DTRA) join Derk Arts of Castor for a candid, no-slides panel. Where in-home models genuinely deliver, what it takes to run them at scale, and where AI-driven record retrieval and data capture help versus where a human still has to. 45 minutes. Live on LinkedIn. 11:00 AM EDT. Register at the link below.

The bar for RWE just moved, and the shift is not what most teams expect. FDA finalized its device RWE guidance in December 2025. The headline is that sponsors who cannot obtain participant-level data are not automatically disqualified. The requirement is that every data transformation, provenance step, and review decision must remain inspectable. That is a harder bar than it sounds. For BioPharma, the standard stays stricter: participant traceability, defensible outcome definitions, and control for confounding are the table stakes. The question is not whether you have enough records. It is whether you can reconstruct why each patient qualified, what each endpoint was, and how the comparator population differs from the treated group. For MedTech, EU MDR transition deadlines are the forcing function. Class III and implantable Class IIb devices face December 2027. PMCF is no longer a periodic documentation exercise. And MDCG 2025-6 confirmed that the AI Act and MDR can apply simultaneously to the same device. Across both tracks: synthetic controls and generative digital twins are not the same thing. One is a recognized regulatory method. The other gets rejected. Our 2027 RWE Playbook breaks down what regulators are actually accepting, what your evidence architecture needs to include, and how to audit your program before the deadline. Access the full playbook on our website by clicking any image below.

A closely watched deal in CRO consolidation is getting a live, on-camera debrief. Derk Arts and Joel White interview Joel Morse, CEO and Co-Founder of Curavit, on his acquisition of Lindus Health's CRO assets. Register now to join us Live on Thursday, August 27th at 11:00 AM EDT / 5:00 PM CEST.

Your team shouldn't spend 39 minutes per chart on manual abstraction. Castor Catalyst: AI-driven extraction, human reviewed, audit-ready.