Clinical Trial Monitoring

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 &Asia Pacific region, 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

Our CRAs have a thorough knowledge of local regulations and GCP processes and undergo continuous training. Our co-monitoring model ensures highest quality, consistency and up to date knowledge in our monitoring services.

 

Our Medical & Safety Monitoring staff, all Physicians (MDs) averaging 5 years of trial experience oversee the protocol eligibility and ensure compliance to national and international guidelines on safety reporting allowing our project teams to execute projects with superior precision in almost every therapeutic area:

  • Provide clinical development plans and protocol design input

  • 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