Statistical Programming
  • Development of study data tabulation model SDTM and ADaM datasets
  • Development of SEND datasets
  • Creation of tables, listings, and figures (TLF), in-text tables & appendices
  • Support of clinical study report (CSR), integrated summary of safety & efficacy (ISS/ISE), interim analysis, agency filings, safety surveillance & publications
  • Support of database edit checks, query creation, patient profiles & ad-hoc reports, as well as data review and monitoring tools such as SpotFire
  • Support of data monitoring committee (DMC) meetings as unblinding programmers
  • Support for statistical method development, simulations, sample size calculations, exploratory analysis, and research projects
  • Acquire sponsor approval on SDTM aCRF, CRT Specification, Datasets and DEFINE.
  • Work within sponsor systems and follow their process for version control.
  • Ensure aCRF and CRT Specification are validated by an independent SDTM Lead or experienced programmer.
  • Validate SDTM datasets via dual independent programming.
  • Review reports from Pinnacle 21 Community SDTM datasets and Define.
  • Stay up to date with the latest versions of the IG, Controlled Terminology, TAUGs.
  • Develop and maintain utilities macros for repetitive tasks.
  • Supporting on aggressive timelines such as PMA Analysis
Clinical Data Management
  • On-shore and off-shore Clinical Data Management Services
  • EDC and Paper Trial Set-Up & Management
  • Certified Medidata RAVE Builders
  • Access to other EDC solutions (Low Cost, Oracle etc.)
  • Data Management Plan (DMP) development
  • Data Management Project Management
  • CRF/eCRF design and development
  • CRF Annotation & Review
  • Database Build & Design
  • Data validation specifications
  • Edit checks Programming & Testing
  • Data processing through double data entry
Clinical Data Management
  • On-shore and off-shore Clinical Data Management Services
  • EDC and Paper Trial Set-Up & Management
  • Certified Medidata RAVE Builders
  • Access to other EDC solutions (Low Cost, Oracle etc.)
  • Data Management Plan (DMP) development
  • Data Management Project Management
  • CRF/eCRF design and development
  • CRF Annotation & Review
  • Database Build & Design
  • Data validation specifications
  • Edit checks Programming & Testing
  • Data processing through double data entry
Biostatistics
  • Support to pre-clinical studies
  • Protocol Input
  • Randomization/Unblinding
  • Statistical Analysis Plan (SAP) and Output Shells
  • Clinical Data Interchange Standards Consortium (CDISC)
  • Output Production
  • Production of Statistical Report/Clinical Study Report
  • Interim Analysis/Data Safety Monitoring Boards (DSMBs)
  • Meta Analysis
  • ISS/ISE