Triangle Biostatistics
A DATATRAK Connect Partner
Triangle Biostatistics was founded to provide statistical consulting and statistical programming services to the pharmaceutical industry. Triangle Biostatistics has over 170 years of combined experience in the industry in large and small contract research organizations (CRO) and large, mid-size and small pharmaceutical companies.
With extensive experience in all phases of drug development and numerous regulatory submissions across various indications, Triangle Biostatistics is positioned to provide strong statistical consulting and programming support utilizing sound scientific reasoning and the latest computing technology. The collaboration with all departments throughout the drug development process ensures the highest quality statistical programming services.
The areas of therapeutic experience include:
- Antivirals
- CNS/Analgesics
- Cardiovascular
- Dermatology
- Gastrointestinal
- Musculoskeletal
- Oncology
- Respiratory
- Urology
Reasons to choose Triangle Biostatistics:
- Protocol development/ Study design
- Sample size determination
- Randomization
- External, independent, unblinded statistician
- Data Monitoring Committee (DMC) support
- Statistical Analysis Plan (SAP) preparation
- Interim and end of study statistical programing (i.e. analysis data sets, tables/ figures/ lists [TFLs] using SAS® and includes program verification)
- Statistical methods of Clinical Study Reports (CSR)
- Clinical Data Management Programming
- Conversation of clinical study datatsets to conform with CDISC standards
- Document review (i.e. protocol, CSR, briefing document, response to regulatory agency, CTD [e.g., 2.7.3, 2.7.4])
- Customized SAS® macro generation
- SOP writing