Clinical Safety
We understand the criticality of maintaining Investigational Medicinal Product & Patient information in clinical trials. Accurate evaluation of safety data is the key to bring a potential drug into market for human benefit.
We offer a wide range of distinguished services for effective analysis of safety data originating from clinical trials.
Clinical Safety Services
- Unblinding of SUSAR reports
- Expedited reporting of cases to WW RAs
- Setting up Adjudication Review, Safety Review, Drug Safety Monitoring Board Committees
Arranging and managing safety review meetings with blinded and unblinded data
- 24 X 7 Medical Monitoring services
Safety Management Plans
- Medical Monitoring Plans
- Blinding / Unblinding Plans
- Data Reconciliation Plans
- DSMB Charters
- Clinical Trial ProtocolsSafety
- Committee Review Charters
- Clinical Study Reports
Other Drug Safety Services
Additional Services
Sitero provides wider range of other support services. We provide best-in-class one-stop solutions to our clients: regulatory intelligence, pharmacovigilance master file (PSMF) Creation & Maintenance, XEVMPD / Article 57 Database Maintenance and PV SOPs Authoring & Maintenance Support.