Techsol’s Biostatistics & SAS programming division is specialized in delivering value-focused services that includes clinical trial design, primary and secondary data points identification, clinical and safety endpoints determination, SAP preparation, interim data analysis, to final data analysis and clinical report preparation.
Our team members are highly knowledgeable in clinical statistic principles such adaptive trial design, time to event analysis, Bayesian modelling and analysis, and non-inferiority approaches and have extensive experience across different indications.
We been working for more than 15 years in NDA/ BLA/PMA submission and actively interacting with FDA, EMEA and PMDA working groups. With an in-depth knowledge on regulatory guidelines such as ICH GCP, ICH E9 and data standards such as CDISC, CDASH and SDTM, our team of SAS Programmers can deliver clean, accurate and enriched data sets that can be be used for determining the safety and efficacy of medicinal products.
How We can Help
- Provide Study Design Statistical inputs
- Sample Size Calculations
- Power analysis, randomization plans, definition of populations
- Preparation of Statistical Analysis Plan
- Generation of periodic Tables, Listings and Figures
- Preparation and execution of interim data analysis plan
- Preparation of statistical reports and providing Data Safety Monitoring Board (DSMB) support
- Actively participate in the development and completion of Clinical Study Report (CSR), ISS/ISE, DSUR, etc.
- Program and deliver CDISC – SDTM / ADaM compliant data sets
- Prepare Risk-benefit Reports
- Expert opinion offerings for adaptive clinical trial design and personalized medicine
- Advanced Regression and Bayesian analysis
- Provide insights on clinical data with advanced analytics
What We Offer
With advanced SAS Programming, we use a wide-range of validated macros and functions to:
- Generate clean clinical trial data sets based on study protocol, Statistical Analysis Plan and STL Template
- Validation of new code changes
- Create standard TLFs across Demographics, Medical History, Prior Medications, Concomitant Medications, Adverse Events and Vital Signs
- Provide graphical patient summaries that can be presented to Data Monitoring Committees
With our extensive knowledge on the Clinical Data Interchange Standards Consortium (CDISC) guidelines, we can deliver the following services:
- Raw data mapping to SDTM and ADaM related domains
- Transposing study data variables under each domain to SDTM and ADaM
- Creation of the define.xml file with the annotated CRFs
- Generation of SAS XPT files for electronic data submission to FDA
- Statistical programming on ADaM derived data sets