Global Biometrics Excellence: Powering Clinical Trial Success
Global Biometrics Excellence: Powering Clinical Trial Success
Founded in 2003, we are an international biometrics service provider with strategic offices acrossthe United States and Asia, serving the needs of pharmaceutical and biotech companies worldwide.International Expertise & LeadershipOur biometrics teams bring together the best talent from across the gl...
Build or Buy? A Guide to Biometrics Resourcing
Build or Buy? A Guide to Biometrics Resourcing
The Strategic Crossroads Every Biotech and Pharma Company FacesIn today's increasingly complex market, where 80% of clinical trials face delays and competition is intensifying, the question isn't whether you need robust biometrics capabilities—it's whether you should build them in-house or partner w...
Interpreting the roles and responsibilities of relevant personnel from the perspective of clinical trial data flow
Interpreting the roles and responsibilities of relevant personnel from the perspective of clinical trial data flow
Clinical trial data can be defined as any information or fact related to a clinical trial. What information in our daily work belongs to clinical trial data? It can be numbers, characters, medical history, medication records, examination reports, records, and signatures, etc. Data can basically be d...
Top 5 Biometrics Mistakes That Delay Clinical Trials
Top 5 Biometrics Mistakes That Delay Clinical Trials
In today's complex clinical development landscape, where trial costs continue to rise and timelines stretch ever longer, biometrics excellence has become a critical success factor. Yet even experienced organizations repeatedly fall victim to common biometrics pitfalls that silently derail timelines ...
Checklist: How to Select a Biometrics Partner
Checklist: How to Select a Biometrics Partner
Choosing the right biometrics partner is a critical decision that can significantly impact your clinical development timeline, budget, and ultimate regulatory success. This comprehensive checklist will guide you through the essential criteria to evaluate potential biometrics partners and help you ma...
3 FDA Rejections You Can Avoid with Better Data Strategy
3 FDA Rejections You Can Avoid with Better Data Strategy
In the high-stakes world of drug development, an FDA rejection can cost years of lost time and hundreds of millions in potential revenue. Even more frustrating? Many of these rejections stem from preventable data issues rather than fundamental efficacy or safety concerns. By implementing a strategic...
SDTM、ADaM or Define.XML: The Three Pillars of Data Standardization in Drug Development
SDTM、ADaM or Define.XML: The Three Pillars of Data Standardization in Drug Development
IntroductionIn drug development and clinical research, data standardization is the cornerstone of ensuring reproducible results, traceability, and compliance with regulatory review requirements. SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and Define.XML—defined by CDISC (Clinical...
Clinical Data Management Services
Clinical Data Management Services
Clinical Data Management ServicesEnsuring Data Quality from Collection to SubmissionGCP ClinPlus delivers comprehensive clinical data management services designed to ensure the integrity, accuracy, and compliance of your trial data from protocol design through database lock. With 22 years of experie...
SAS Programming Services
SAS Programming Services
Transform Your Clinical Data into Regulatory-Ready DeliverablesGCP ClinPlus delivers expert SAS programming services to help sponsors convert complex clinical data into submission-ready datasets, tables, listings, and figures. With 22 years of experience supporting over 2,200 successful projects, ou...
Biostatistics Services
Biostatistics Services
Excellence in Clinical Trial BiostatisticsWith 22 years of industry experience, GCP ClinPlus delivers unparalleled biostatistical expertise across the full spectrum of clinical development. Our biostatistics services form the foundation of successful clinical trials, ensuring methodological rigor, r...