Statistical Programming

• Clinical Study Reports (CSR) to Evaluate Study Safety and Efficacy
  • Generating CDISC ADaM-IG Compliant Analysis Datasets
  • Generating Tables, Figures, and Listings
  • Interim Analysis and Final CSR
  • ISS: Integrated Summary of Safety
  • ISE: Integrated Summary of Efficacy
  • Ad-hoc Reporting
• Regulatory Safety Updates (PBRER, DSUR, PSUR, SWG, SRT, EU-RMP, DMC, IB)
• IDMC Services: Two-Team (Blinded/Unblinded) Reporting, IDMC Chart, Blinding Plan, Executive Summary
• SDTM Conversion Services: Mapping and Generating CDISC Submission-Ready SDTM Datasets
• Regulatory Submission Services (Define.xml Packages for FDA, PMDA, and Other Regulatory Agencies: Reviewer’s Guide, Define.xml, SAS Programming Documentation, ARM-Analysis Result Metadata Package)
• FDA BIMO Packages (Clinsite Dataset, Subject-Level Data Listings by Clinical Site, Reviewer’s Guide, and Define.xml)
• Patient Profile and Patient Narratives
• ClinicalTrials.gov Posting
• Study Data Anonymization for Publication
• Retrofitting Legacy Studies (Converting Legacy Datasets and Reports for CDISC-Compliance (SDTM, ADaM, Define) and Submission Ready)

Biostatistics Services

• Trial Design and Statistical Input to the Protocol
• Power and Sample Size Calculations
• Randomization
• Statistical Modeling/Exploratory Analysis
• Statistical Analysis Plan (SAP) Development
• Table, Figure, Listing Shell Development
• Statistical Contribution to CSR
• Statistical Interpretation and Representation to Regulatory Meeting

Functional Service Provider (FSP)

BioPier, a Veramed Company, provides Functional Service Provider (FSP) services to meet clients’ unique needs. This model enables clients to separate core and non-core capabilities while maintaining control and cost, retaining strategic oversight, and integrating directly into their operations. Veramed, BioPier’s parent company, can offer flexibility and multiple tiers of FSP resources in the USA, UK, Ukraine, and India to achieve the best quality while keeping the cost low. Our vast therapeutic experience and network enable us to recruit and screen qualified professionals in the desired therapeutic area, with expertise in biostatistics, statistical programming, data management, CDISC standards, regulatory submission, and project management.