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Cases & Articles
Ophthalmic Trial Endpoints and Centralized Imaging Evaluation
04/16/2026
Ophthalmic Trial Endpoints and Centralized Imaging Evaluation
I. Overview of Clinical Trial Endpoints for Common Ophthalmic DiseasesThe appropriate selection of endpoints in ophthalmic drug clinical trials directly determines the scientific validity of a study a...
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A Practical Guide to CGT Clinical Trial Compliance: Key Points from Design to Inspection
03/06/2026
A Practical Guide to CGT Clinical Trial Compliance: Key Points from Design to Inspection
IntroductionCell and Gene Therapy (CGT) is transforming the treatment landscape for difficult-to-treat diseases, particularly cancers and rare disorders. However, the path from lab to market remains s...
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Designing Compliant Clinical Trial Protocols for Innovative CGT Products: Key Considerations from a Clinical Design Perspective in the Pre-IND Stage
03/02/2026
Designing Compliant Clinical Trial Protocols for Innovative CGT Products: Key Considerations from a Clinical Design Perspective in the Pre-IND Stage
As Cell and Gene Therapy (CGT) products transition from the laboratory to the clinic, the design of the clinical trial protocol is not only the starting point for scientific exploration but also the c...
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Global Biometrics Excellence: A Decade-Long Partnership Driving Pharmaceutical Success
08/19/2025
Global Biometrics Excellence: A Decade-Long Partnership Driving Pharmaceutical Success
Executive SummaryGCP ClinPlus established a transformative decade-long partnership with a US biotech company, delivering comprehensive biostatistics and SAS programming capabilities that significantly...
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Case Study: Strategic Clinical Oversight Accelerates Oncology Approval
08/19/2025
Case Study: Strategic Clinical Oversight Accelerates Oncology Approval
In the fast-paced field of oncology drug development, the addition of a new indication often presents complex regulatory, operational, and scientific challenges. In late 2024, ...
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Case Study: Scalable Programming Excellence with FSP
08/19/2025
Case Study: Scalable Programming Excellence with FSP
GCP ClinPlus Enhances Trial Delivery for a U.S.-Based Ophthalmology SponsorThe ChallengeDuring a critical phase of multiple ophthalmology trials, the sponsor faced fluctuating programming workloads ...
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