Our statisticians and programmers analyze data for endpoint determination; perform statistical procedures and evaluation criteria, customized programming services and data display formats as per regulatory

 requirements. Our team is committed to providing the highest quality services, working together with the Sponsor’s goal in mind. Flexibility remains a key priority. Our team is experienced in designing, analysis and reporting of Phase I-IV clinical trials of various indications. We operate a peer-review by dual independent programming of critical endpoint analysis, and all the outputs are subjected to QA review.

Our services and systems are governed by well defined SOPs and are compliant with regulatory requirements.

Biometrics Services include:

• Sample size calculation
• Inputs to statistical section of Protocol
• CRF Review and Annotation
• Randomization Schedule
• Development of Statistical Analysis Plan (SAP)
• Programming of SAS datasets as per CDISC Standards (SDTM and ADaM)
• Programming of Tables/Listings/Figures
• TRTD Analysis
• Exploratory Analysis
• Interim Analysis
• Statistical Analysis and Reporting