GCP ClinPlus Enhances Trial Delivery for a U.S.-Based Ophthalmology Sponsor

The Challenge

During a critical phase of multiple ophthalmology trials, the sponsor faced fluctuating programming workloads driven by concurrent studies and accelerated timelines. Internal capacity was stretched, and hiring full-time staff was neither feasible nor timely.

· Rapid expansion of programming support to meet urgent deadlines

· High-quality, regulatory-compliant outputs across SDTM, ADaM, and TLFs

· Scalable resourcing without compromising quality

· Consistent delivery speed with minimal oversight or delay

· Direct access to experienced programmers without full outsourcing complexity

GCP ClinPlus Solution

A. FSP Model: Flexible, Scalable, Seamless

1. Tailored Resourcing: Embedded experienced SAS programmers aligned with project timelines.

2. On-Demand Scalability: Ramped up during peak phases and scaled back during quieter periods.

3. Reduced Hiring Burden: Provided immediate productivity without permanent hires.

B. Programming Quality & Compliance

4. Standardized Deliverables: CDISC-compliant datasets and publication-quality TLFs.

5. Experienced Expertise: Senior programmers for SDTM, ADaM, and submission reports.

6. Real-Time QC: Integrated validation workflows for high accuracy.

C. Integrated Collaboration

7. Workflow Continuity: Programmers integrated into sponsor’s tools and platforms.

8. Direct Communication: Open lines with sponsor teams for rapid feedback and issue resolution.

9. Minimal Onboarding: Fast adoption of sponsor SOPs with zero timeline disruption.

Achievements

· Rapid Deployment: Full support within 30 days, meeting critical milestones.

· Cost Efficiency: Reduced staffing costs by avoiding fixed headcount increases.

· Consistent Delivery: Maintained CDISC compliance across concurrent trials.

· Operational Agility: Dynamic team sizing matched project phases.

· Improved Responsiveness: Real-time collaboration streamlined execution.

Why the FSP Model Works

The FSP model combines dedicated team integration with outsourcing flexibility, enabling rapid response to trial demands, seamless programming continuity, and high compliance—without long-term staffing risk.

Ready to Unlock Flexible Programming Support?

Whether you're managing peak study timelines or scaling across multiple trials, GCP ClinPlus delivers flexible, high-quality biometrics support through our proven FSP engagement model. Reduce cost, minimize risk, and maintain quality at every development phase.

Contact:

Suling Zhang, VP of International Operations and Business Development

Email: suling.zhang@gcp-clinplus.com

Phone: 609-255-3581