We take a full 360° approach that looks at study design, analysis and endpoint strategies. As an extension of your team, everything we do supports your methodology, statistical analyses and randomization schedule. Clear, concise, considered.
Our statisticians collaborate with medical writers and clinical scientists who are experts in their fields, across a broad spectrum of disciplines. Where our teams really come into their own is their excellence, not just in analysis, but also in the interpretation and audit-ready reporting of results.
We provide support for:
- Randomization schedule creation and integration with investigational product management, Interactive Voice Response (IVR) and Interactive Web Response (IWR) systems
- Creation of Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) submission ready datasets using industry-standard SAS® software
- TLF generation and reporting
- Data and Safety Monitoring Board (DSMB) output, interim analysis and Investigational New Drug (IND) safety updates
- Development of comprehensive methods reports, exploratory analyses and support for manuscripts and abstracts
Get in touch to find out more about biostatistics.
Clintec’s Biostatistics Service, combined with Data Management and Programming, is an extension of the Biometrics department, led by Jeanne Strain, and is incorporated within our Project Management Office.
Jeanne Strain, Global Head, Biometrics
Jeanne has over 30 years of industry experience in Data Management and Biostatistics, with 20 years in the CRO space. Prior to this she spent 16 years at a major pharmaceutical company with the majority of her time focused on Data Management Operations as well as selection, validation and implementation of clinical systems. Jeanne has been responsible for providing leadership for Data Management, Biostatistics, Statistical Programming, Medical Writing, Interactive Response Technology and Document Management & Publishing departments globally. Jeanne has experience in all phases of clinical trials from Phase I through IV, post-approval studies and a multitude of therapeutic areas. She has overseen operations on three continents and seven countries, including significant experience overseeing operations in Asia-Pacific, allowing for greater efficiency and cost containment. Jeanne received her BS in Biochemistry from Rutgers University and her MS in Biology with a minor in Business from Seton Hall University.