Castor Blog

Q4 CRO revenues grew. Bookings accelerated. So why the AI panic? Joel White breaks down what the numbers actually mean.

Alison Bishop and Derk Arts on what AI actually replaces in Phase 2/3 data management, with a deep dive on the future of edit checks.

Phase 4 is a post-approval interventional trial that fulfills regulatory commitments. Real-world evidence spans PASS, PAES, HEOR, natural history studies, and more — each built to answer a different question for a different stakeholder. This piece maps the full range of post-approval study types, where Phase 4 and RWE genuinely converge, and how to treat both as part of a coordinated evidence strategy.

ICH E6(R3) is in effect. Castor’s recap covers centralized monitoring, sponsor accountability, and closing the biotech RBQM gap.

Castor’s on-site ePRO adds in-clinic PRO capture to the ePRO/CDMS workflow you already use. Staff use a site device or share a QR code for BYOD. Progress saves automatically during completion, and participants can finish remotely. It reduces missed baseline at FPI. It supports decentralized and hybrid designs. It improves audit readiness and compliance tracking. No separate site app or provisioned hardware. This article recaps the webinar, shows the clinic flow, and answers common questions.

Analysis of 735 FDA drug approvals reveals 0% EQ-5D labeling inclusion, while European HTA bodies demonstrate 18% technology appraisal acceptance. Companies repositioning EQ-5D from FDA regulatory strategy to European HTA advantage secure faster reimbursement approvals. German HTA bodies show highest global acceptance rates, NICE maintains established preference despite 5L controversies, and French HAS recognizes EQ-5D within economic evaluation frameworks. Strategic implementation focuses on health economic modeling rather than clinical outcome measurement, with HTA-optimized deployment (12-16 weeks) providing superior ROI versus regulatory claim attempts. Success requires country-specific value sets and preference weights.

Electronic Clinical Outcome Assessment (ECOA) and electronic Patient Reported Outcomes (ePRO) represent far more than digital surveys in clinical trials. This foundational guide explains the four ECOA components (ePRO, eClinRO, eObsRO, ePerfO), why BYOD delivers superior patient compliance over provisioned devices, and the hidden complexities of copyrighted instruments approval. Discover why commercial trials demand specialized expertise in linguistic validation, regulatory compliance, and measurement equivalence that academic research often overlooks. Essential knowledge for clinical operations professionals planning their next patient outcome strategy.

Electronic clinical outcome assessments (eCOA) were supposed to solve data quality and amplify the patient voice. Yet missing baseline data, poor site readiness, and disorganized planning still derail trials. Experts from Castor, Kielo, and RTI Health Solutions share where the true failures occur — and what you can do to prevent them. With a focus on practical, experience-based advice, this article breaks down why eCOA problems persist and how sponsors and CROs can build simpler, more resilient study designs that actually work in the real world.

Gameto proves you don’t need a large CRO or a floor of data managers to run complex global trials. With only three people in clinical operations, the biotech launched nine IVF studies across Peru, Mexico, Australia, and the United States, built full Spanish CRFs in three weeks, and delivered the 38-patient dataset that moved Fertilo straight into FDA Phase 3. Castor EDC gave the team version control, multilingual forms, and audit trails—without slowing them down. If you care about lean, regulator-ready execution, this case study is worth ten minutes of your time.