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Biostatistics and Programming

Biostatistics

Our Biostatisticians ensure your clinical study is designed correctly from the start by calculating efficient sample sizes and selecting the most appropriate statistical analysis methods for your clinical endpoints. In addition, our Biostatisticians oversee your clinical trial from start to finish to ensure data is collected correctly and is ready for analysis at the end of the study.

Our experience has taught us that regulatory agencies focus their reviews on the presented statistical analyses, and our expert Biostatisticians ensure your clinical study messaging is as clear and as accurate as possible.

Programming

Our Statistical Programmers ensure all datasets and outputs required by regulatory agencies are accurate and easily readable. All ProPharma Group outputs that are submitted to regulatory agencies or publications are always independently double programmed by two Statistical Programmers and reviewed by at least two Statisticians to ensure acceptance by the regulatory authorities.

Therapeutic Areas

ProPharma Group’s Biostatistics and Programming experts can offer support for a wide range of therapeutic areas. We have specific and recent experience with the following: Oncology, Rare Disease, Vaccines, CNS, GI, Cardiovascular, and Hematology among others.

Additional Services Outside of the Clinical Trial

In addition, we offer Statistics and Programming services for more than just your clinical trial. We can and have supported clients with everything from manuscript publications to New Drug Application (NDA)/Biologics License Application (BLA) submissions and everything in between. We have supported Health Economics and Outcomes Research (HEOR) as well as Real-World Evidence (RWE) projects for our clients in addition to machine learning development and expanded access data summarization.

  • Study Design and Input
    • Sample Size Calculation
    • Adaptive design trials
    • Analysis methods for primary, secondary, and exploratory endpoints
    • Analysis Population definitions
    • Protocol input (statistics section)
    • Randomization scheme/plan
  • Clinical Data Interchange Standards Consortium (CDISC) Dataset Creation (with associated/required documentation)
    • Study Data Tabulation Model (SDTM), including Specifications, Definitions, and Reviewer’s Guide
    • Analysis Data Model (ADaM), including Specifications, Definitions, and Reviewer’s Guide
    • Legacy Conversion (we can take your old non-CDISC study data and convert it to CDISC compliant datasets for FDA submission)
  • Statistical Analysis Plan Creation
  • Shell creation of tables, listings, and figures (TLFs)
  • Topline TLFs
  • Final TLFs
  • Clinical Study Report (CSR) review and input
Vendor Oversight
  • When you have outsourced your trial to a Clinical Research Organization (CRO) but do not have an in-house Statistician to review the CRO’s work, ProPharma Group can provide an embedded team of Biostatisticians and Statistical Programmers to review and oversee the CRO and answer their statistics and programming related questions.
  • Integrated Summary of Safety (ISS) SAP
  • Integrated Summary of Efficacy (ISE) SAP
  • Integration/pooling plan (SDTM or ADaM level)
  • Study Data Standardization Plan input and discussions with agency
  • Bioresearch Monitoring (BIMO) listings and ClinSite dataset creation
  • DSMB/DMC charter input
  • Unblinded independent statistician support
  • Unblinded output for DSMB
  • Executive summary and meeting attendance
Development Safety Update Reports (DSUR) TLFs
  • ProPharma Group’s statistics and programming team has extensive experience in quickly and accurately compiling the reports required for your annual DSUR reporting.
Investigator Brochure (IB) TLFs
  • Providing meaningful information clearly to your investigators is one of the most important things you can do for your IP. ProPharma Group’s biostatisticians will work with you to formulate the best way to clearly articulate the information you need to provide your investigators.
Manuscript Support and Input
  • ProPharma Group’s statisticians can assist in the review and organization of your data to provide suggestions for possible analyses to be included in posters and publications.
  • Support includes the creation of tables, listings, and figures to be included in the poster or publication as well as the provision of statistical analysis methodology and results text.
Real-World Evidence (RWE) 
  • We have extensive experience handling real-world evidence data. From claims data to product registries, we can help analyze your RWE.
Health Economics and Outcomes Research (HEOR) 
  • ProPharma Group has robust experience in defining and developing cohorts to make meaningful outcomes and economics claims.
  • Prepare briefing books
  • Data summarization
  • Address agency questions
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