Our Services
We are a premium biostatistics & programming provider that evaluates drugs' efficacy and safety for FDA or global drug approval.
Explore the Therapeutic Areas we have been involved in over the past five years.
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
Our Service History
Over the past 3 years, our team has delivered:
- NDA/sNDA/BLA Submissions: 8
- Studies of Phase I-IV CSR, IA, ISE, ISS: 29
- Studies of Define.xml Packages: 23
- Studies of Safety Reports (SRT/SWG/IB/EU-RMP/DSUR/PSUR/DMC): >100
- Studies of Data Conversions to SDTM: 10
- Ad-hoc Analysis: Numerous
Clinical Workbench Customizations
If you'd like to customize Clinical Workbench to fit your organization, or you'd like to extend the functions into cross-department corporate portals, we can help.