Our Capabilities and Recent Accomplishments

Biostatistics Support for Clinical Studies

• Provide input on the power/sample size for various study designs
• Generate randomization schedule
• Review CRF design to ensure data collection meets the protocol objective
• Assist protocol design and write the statistical section
• Support interim analysis and data safety monitoring board
• Develop SAP including mock tables for individual studies or ISS/ISE (Integrated Summary of Safety/Integrated Summary of Efficacy)
• Assist data review, and protocol deviation/violation and per protocol eligibility determination
• Create patient profile listings or plots for data review and case presentation
• Program in SAS for TLFs
• Review CSR to ensure data analysis/presentation meets the study objective and the relevant FDA guidance
• Review ISS/ISE and NDA SCS/SCE (Summary of Clinical Safety/Summary of Clinical Efficacy, CTD 2.7.2, 2.73, and 2.7.4) to ensure data analysis/ presentation matches with the intended drug label and the regulatory requirements
• Represent the sponsor in the FDA meeting
• Ad hoc analysis or data mining

Standardization and Compliance to the FDA eSubmission Requirement

• Create CDISC SDTM (Clinical Data Interchange Standards Consortium Study Data Tabulation Model) datasets from raw datasets
• Annotate the CRF for SDTM datasets
• Create Define.xml for SDTM datasets
• Create analysis datasets or CDISC ADaM datasets (Analysis Data Model) and the associated Define.xml
• Program in SAS for TLGs using the FDA recommended linear process (from raw data to SDTM to analysis data (or ADaM) to TLGs)

Preparation of the Statistics Package in the FDA eSubmission-ready format

• Check datasets for compliance to the FDA eSubmission requirements (including SDTM format)
• Create datasets in SAS v5 Xport format for all studies
• Create the folder structure per eSubmission requirement
• Copy SAS datasets, aCRFs, Define.xml, and programs into the respective folders
• Create hyperlinks in the Define.xml for SAS datasets, aCRFs, and programs

Data Management Support

• Design eCRF (EDC) compliant to CDASH
• Create edit check specifications to be implemented by the EDC vendor
• Conduct UAT (user acceptance test)
• Write CRF Completion Instruction
• Develop Data Management Plan
• Perform data review and write/resolve queries
• Provide metric report
• Provide data listing review
• Reconcile EDC data with external data (eg, lab or EKG)
• Assist the SAE reconciliation
• Lock the database

PDA's Recent Accomplishments

3 NDA successfully filed

• SAPs for ISS/ISE covering 3 Phase 3 and over 9 Phase 1/2 studies (legacy)
• SDTM and ADaM compliant
• All ISS/ISE TLFs, plus FDA’s BIMO data set and listings
• Section 2.7.3 and 2.7.4 review

3 Phase 3 studies and 5 Phase 2 studies

• SAP/TLF shells, statistical analysis and TLFs generation
• SDTM and ADaM compliant (phase 3)
• CSR review

Protocol development

• 1 Phase 3 study and 8 Phase 2 studies

Passed the client’s pre-Phase 3 and Post NDA biostatistics audits

• Provided all necessary SOPs and Biostatistics document to the client
• No questions on biostatistics from the FDA's client audit