Clinical Development & Operations
Your clinical program is where science becomes evidence - and where approval is won or lost.
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
Medical Writing & Documentation
- Clinical study reports, protocols, and investigator brochures
- Integrated Summaries of Efficacy and Safety (ISE/ISS)
- Marketing applications and regulatory submissions
- Real-world evidence (RWE) study design and execution
GxP Quality & Inspection Readiness
- GxP quality assessment, gap analysis, and remediation
- Data integrity programs: policies, training, and system controls
- Clinical SOP development and harmonization
- Audit and inspection preparation – FDA, EMA, and global health authority readiness
- Drug safety and pharmacovigilance functional support
Trial Operations & Execution
- Clinical project management from planning through close-out
- Trial team management and sponsor oversight for outsourced and hybrid programs
- CRO selection, qualification, and ongoing performance governance
- Ethics committee submissions and national authority interactions
- Trial Master File set-up, maintenance, and audit readiness
- ICH-GCP compliance and regulatory guidance alignment throughout
Where we outperform
- Adaptive trial design – master protocols, basket, umbrella
- Decentralized and hybrid trial experience across global geographies
- Tight integration with pharmacometrics for simulation-informed designs
- Functional and role-based support CPMs, CRAs, data management, statistical programming
- In-country CRO execution in Italy and Spain – not a referral, part of your team
