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Cases & Articles

Cases & Articles
Biostatistics Services
08/18/2025
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. ...
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SAS Programming Services
08/18/2025
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, ...
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Clinical Data Management Services
08/18/2025
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, ...
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SDTM, ADaM or Define.XML: The Three Pillars of Data Standardization in Drug Development
08/18/2025
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 ...
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3 FDA Rejections You Can Avoid with Better Data Strategy
08/18/2025
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 ...
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Case Study: World's First 40kD Y-PEG Long-Acting Growth Hormone Approval
08/18/2025
Case Study: World's First 40kD Y-PEG Long-Acting Growth Hormone Approval
Supporting Amoytop Biotech's Breakthrough Innovation in Pediatric EndocrinologyExecutive SummaryOn May 29, 2025, Amoytop Biotech achieved a groundbreaking milestone with NMPA approval of Yipeishen...
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