Email:
global@GCP-ClinPlus.com
Post-approval studies are essential for validating the long-term safety, effectiveness, and real-world performance of therapies after market entry. GCP ClinPlus offers full-service capabilities for Phase IV trials, real-world evidence (RWE) studies, and long-term follow-up (LTFU) programs, including through China's Boao Lecheng Pilot Zone, which supports accelerated access and regulatory acceptance of real-world data.
With over 22 years of experience, a CRA presence in 50+ cities, and a proven track record in large-scale observational studies, we help global sponsors meet regulatory requirements, expand indications, and generate evidence that drives product optimization, access, and lifecycle value.
In the post-approval phase, the focus shifts from tightly controlled clinical environments to real-world use across diverse populations and timeframes.
Our services include:
Post-Marketing Safety Studies (PASS) for drugs, biologics, CGT, and devices
Large-scale RWE programs, including health economics and outcomes research (HEOR)
Long-Term Follow-Up (LTFU) studies, such as 5–15 year CGT/device surveillance
Phase IV label-expansion trials for new indications, populations, or combinations
Boao Lecheng RWE pathway for innovative imported drugs and devices
Boao Special Pathway Capability:
As one of the few CROs with experience supporting real-world studies in the Boao Lecheng International Medical Tourism Pilot Zone, we help sponsors:
Import innovative therapies already approved overseas
Conduct Boao-based RWE studies to support NMPA approval or indication expansion
Design study protocols aligned with real-world acceptance standards
Our operational strengths:
Executed one of China's largest real-world studies: 3,443 patients across 62 hospitals over 8 years
Dedicated CRAs in 50+ cities, ensuring nationwide oversight
Integrated data capabilities including CDISC, eCRF, mobile data collection, and centralized PV systems
In-house medical experts and PhD-level statisticians experienced in longitudinal data analysis
From post-marketing surveillance to lifecycle management, GCP ClinPlus delivers efficient, compliant, and high-impact post-approval solutions.
Comprehensive Coverage: Phase IV, RWE, LTFU, PASS, and registries.
Boao Lecheng Expertise: Real-world data pathway for regulatory and indication expansion.
Scalable Execution: From 1-site observational studies to multi-year, multi-hospital programs.
Regulatory Alignment: Familiar with NMPA, FDA, EMA post-approval expectations.
Data Science Leadership: Deep expertise in real-world data analytics, HEOR, and longitudinal modeling.
Nationwide Site Network: CRA teams across 50+ cities ensure effective site management.
Digital Infrastructure: eCRF, mobile reporting, patient retention platforms, and digital consent.
Proven Track Record: 100% audit pass rate across 140+ post-marketing trials.
Let us help you unlock real-world value—by supporting your therapy long after launch.
GCP ClinPlus delivers exceptional expertise with genuine commitment to our projects. Their team demonstrates remarkable responsibility at every stage, consistently going above and beyond. In an industry where dedication matters, they've proven themselves an invaluable partner for our success.
After enrollment challenges with our previous CRO threatened our study timeline, GCP ClinPlus stepped in and transformed our project. Their team rapidly accelerated patient recruitment beyond our expectations and put our critical study back on track. Their clinical expertise and swift implementation proved decisive in securing our study's success.
GCP ClinPlus stands out for their exceptional responsiveness and customer focus. Their team consistently prioritizes our needs with prompt, thoughtful solutions to every challenge. Their combination of technical excellence and client-centered approach makes them a truly strategic partner in our development programs.