Clinical Operations

Early Phase Studies (BA/BE & Phase I)

We specialize in conducting early-phase clinical studies, including Bioavailability/Bioequivalence (BA/BE) and Phase I trials. Our team has significant experience in setting up new facilities for Phase I studies and delivering customized services tailored to sponsor requirements. This accelerates the drug development process and ensures a seamless transition to subsequent phases.

Phase II & Phase III

Our clinical operations team is highly experienced in managing Phase II and Phase III clinical trials. We collaborate with trained and qualified investigational sites that meet regulatory and ethical standards. Our team has achieved global recognition, ranking 1st and 2nd in recruitment for several Phase II and III studies. We focus on efficient subject recruitment and retention strategies to ensure evaluable data and timely trial completion.

clinical-operations

Phase IV & Observational Studies

We have access to a large and diverse investigator database across various therapeutic areas for Phase IV and observational studies. With our extensive experience, we partner primarily with government institutions and high-patient-volume sites to achieve enrolment targets efficiently.

Our dedicated team also supports patient and physician surveys, analysis of health records and patient registries, and prospective data generation. Our medical writers, in collaboration with our data analysts and biostatisticians, assist sponsors in preparing study publications.

Progress Monitoring & Site Closure:

Our team ensures consistent oversight throughout the clinical trial lifecycle—from active monitoring to study closeout. Key activities include:

  • Planning, scheduling, and conducting site visits,  covering all on-site activities to ensure protocol compliance and data integrity
  • Providing detailed follow-up visit reports  to document findings and ensure timely issue resolution
  • Conducting site closeout visits,  including verification of essential documents, resolution of outstanding action items, and final data reconciliation
  • Submitting study closure documentation  to Institutional Review Boards (IRB)/Ethics Committees (EC) as required

Our structured monitoring and regulatory compliance ensures data quality and smooth transition from active trial phases to study closure.

Site & Logistics Management:

Our Site & Logistics Management team ensures seamless coordination between sponsors and clinical trial sites. Key responsibilities include:

  • Maintaining regular communication with sites to ensure alignment on study progress and timelines
  • Tracking and managing subject recruitment to meet enrolment targets efficiently
  • Providing timely updates and notifications to sites regarding protocol amendments, regulatory changes
  • Reviewing monthly site performance metrics to identify areas for improvement and ensure compliance with study requirements