We manage serious adverse event (SAE) reporting workflows, follow-up and reconciliation in line with Indian regulatory timelines and sponsor requirements.
Medical writing
Our medical writers prepare protocols, investigator brochures, informed consent documents, clinical study reports and manuscripts that are scientifically accurate and easy to review.
What is included
- SAE reporting and follow-up
- Safety database reconciliation
- Periodic safety reports
- Protocols and informed consent forms
- Clinical study reports
- Publications and manuscripts
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.