Biostatistics

• Power and Sample size calculation
• Statistical review of protocol and CRF
• Statistical Analysis Plan
• Randomization
• Interim Analysis
• PK/PD Modelling
• TLF Generation
• Study Analysis and Reporting
• Statistical Programming using SAS / SPSS / R

CDISC

• SDTM mapping, programming and validation
• Creation of Define.xml
• Creation of ADaM domains

Medical Writing

• Scientific & Publication Writing & Review
• Content writing related to Medical Marketing
• All aspects of Regulatory writing & Review

Regulatory, Compliance & Audits

• Clinical Trial compliance including project, process and vendor audits
• GMP compliance auditing including facility, vendor, clinical trial material
• GLP compliance auditing including study documents & vendor
• Computer System validation including software, infrastructure, SOP, IT services
• 21 CFR Part 11 compliance
• Data integrity assessment & compliance towards US FDA warning letters remediation
• Risk Management and quality system for Pharmaceuticals
• Risk Management and quality system for Biosimilars and vaccines
• QMS Requirements, documentation and audits for Medical Device
• Strategic consulting for FDA compliance & Quality assurance