ACT Brief: CRO Consolidation in Regulatory Services, Reimbursement in Development Planning, and Site Selection Misalignment

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• Veristat announced its intended acquisition of Certara's Regulatory and Medical Writing business, adding over 200 industry experts to its regulatory affairs and medical writing operations. The deal reflects broader consolidation in regulatory services, where sponsors increasingly seek partners managing the full arc of submission preparation without handoffs across multiple vendors, with closing expected in Q2 2026.
• In part three of his interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, made the case for integrating reimbursement probability into the standard PTRs framework earlier in development. Sponsors reaching approval without a viable value story face commercial barriers that could have been addressed upstream through earlier alignment between clinical efficacy and market access strategy.
• In a new contributed article, site selection misalignment drives predictable downstream consequences including delayed startup, lagging enrollment, and increased protocol deviations. High-performing sites treat feasibility strategically rather than administratively, and the industry should shift focus from volume to fit by improving transparency in selection criteria and engaging sites earlier in study planning.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.