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Engaging with Regulators for Single-Arm Oncology Research Trials
When well-planned and well-executed, single-arm trials can accelerate access to life-saving therapies that might otherwise never reach desperate cancer patients. read more
Hasty Decisions, Runaway Projects
Despite the best intentions of ISO and EMA, the pharma industry is still largely failing to exploit its data in a strategic, joined-up way - and this could now restrict companies’ ability to capitalize on AI. read more
Status Of AI Regulation On Drug Development
As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. read more
Should Sponsors Provide Source Document Templates?
Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats. read more

Clinical Trials - Transforming Drug Development
Transforming Drug Development: Accelerating Clinical Trials through Patient-Centric Innovations and Technological Breakthroughs Watch Now

Sanner Unifies Global Operations Under Single Brand
Tuesday, June 23, 2026
Sanner is rebranding its subsidiaries under a single Sanner Group umbrella, beginning with the transition of UK-based Springboard to Sanner UK. read more
Sartorius, LFB BIOMANUFACTURING Deepen Alliance on Cell Line-to-Clinic Services
Tuesday, June 23, 2026
Sartorius and LFB BIOMANUFACTURING have expanded their collaboration to provide biopharmaceutical clients with an integrated service offering that ... read more
FDA Outlines New Actions to Accelerate and Modernize Clinical Drug Development
Tuesday, June 23, 2026
The FDA is rolling out a series of reforms intended to accelerate and modernize clinical research across the full continuum of drug development, from ... read more
Piramal Pharma Solutions Reports Strong Year Across 200-Plus Customer Audits
Monday, June 22, 2026
Piramal Pharma Solutions (PPS) said it completed more than 200 customer audits and secured over 70 regulatory approvals across its global network over... read more
Minaris Enhances GMP Cell Banking Suites at Philadelphia Facility
Thursday, June 18, 2026
Minaris announced the enhancement of its dedicated GMP cell banking suites at its Philadelphia facility, a centralized hub for cell banking and ... read more