Services
Our team of highly acclaimed consultants who have demonstrable expertise in the respective domain will be able to execute the following services with perfection.
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
For any queries on our services, please send email at admin@scientiabio.com or call us at +91 80 4169 2453