Your clinical program is where science becomes evidence, and where approval is won or lost.
Most development delays are not scientific failures. They are operational ones – a trial that enrolled too slowly, a protocol that required three amendments, a CRO that was poorly selected and inadequately overseen, a data package that did not meet the evidentiary bar regulators expected. PLG eliminates these risks before they become your reality.
Our Clinical Development & Operations capability is built from two decades of combined expertise and anchored by fully operational CROs in Italy and Spain. We deliver clinical strategy, trial execution, and operational leadership as a single, integrated offering – across North America, Europe, JPAC, and beyond. Whether your program is fully in-house, partially outsourced, or entirely delegated to a CRO, we embed the right expertise at the right level, at the right moment.
Clinical Strategy & Program Leadership
- Clinical development strategy from Phase 1 through Phase 4, including post-approval and observational studies
- Protocol design and endpoint selection aligned to EMA and FDA requirements
- Endpoint strategies informed by market access and reimbursement considerations
- Adaptive and simulation-informed trial designs, leveraging PLG’s pharmacometrics capabilities
- IND/CTA preparation and regulatory interface
- Risk management frameworks built into the program from day one
- Core team support and cross-functional coordination