Through meticulous planning and co-ordination, our Project Managers provide leadership and direction to build a top-notch project team to deliver projects with clear focus on providing qualitybacked by on-time and on-cost deliverables.With access to sites and patient pools across India.

our Project Managers and Clinical Research Associatesleverage on years of experience to deliver quick patient enrollment, high patient retention and generation of clean auditable data.

Clinical Trial Monitoring services include :

• Project management
• Regulatory and protocol compliance monitoring
• Obtaining local EC/IRB approvals
• Supply inventory management
• Training to project and site teams
• DSMB formation and management
• Train Clinical Trials staff and investigators
• Advises protocol team on safety oversight
• Preparation of SAE narratives for regulatory reporting
• Communication to sponsor & relevant authorities within the defined timelines
• Evaluates adverse events/SAEs and reviews safety reports
• Medically review all study team deliverables such as final narratives or clinical study reports