Our data management team designs eCRFs, edit checks and data management plans, then cleans data continuously so that database lock is fast and predictable.
Statistical expertise
Biostatisticians support sample-size calculations, randomisation, statistical analysis plans and tables, listings and figures for clinical study reports.
What is included
- eCRF design and edit checks
- Data management plans
- Query management and data cleaning
- Medical coding (MedDRA, WHO-DD)
- Statistical analysis plans and TLFs
- 21 CFR Part 11-compliant systems
Frequently asked questions
How quickly can you deliver feasibility?
We usually deliver a site-by-site feasibility assessment with realistic enrollment projections within five to seven business days of receiving a protocol synopsis under NDA.
Do you support medical device investigations?
Yes. We support pilot, pivotal and post-market clinical investigations of medical devices and in-vitro diagnostics in line with the Medical Devices Rules, 2017.
Can you work with overseas sponsors and CROs?
Absolutely. We regularly act as the local execution partner for international sponsors and CROs, supporting regulatory submissions, site management and monitoring in India.
What does your quality system look like?
We operate under a documented quality management system with SOPs, training records, internal audits, CAPA management and regular mock inspections at sites.