Associations with experienced physicians and coordinators across India, which is continuously expanding.

Accelerated patient recruitment if necessary, by employing our one of its kind PRS.

Evaluation of site facility, resources, source documentation practices, Ethics Committee SOP etc.

Recognition and development of prospective Principal Investigators.

Translation and validation of ICF in required vernacular languages.

Preparation and submission of EC dossier and follow-up on queries (if any)

Functioning of site at par with site specific SOPs.

Appointment of trained site coordinator for smooth implementation of the trial in fulfilment with protocol, schedule of events and applicable regulatory guidelines.

Meeting the project timelines for patient enrolment and data management matrices.

Meeting the highest quality matrices for protocol compliance, patient follow-up, safety reporting, IP accountability, CRF completion (paper/e-CRF), and compliance with ICH-GCP and applicable regulatory guidelines.

Facilitate the monitoring visits by keeping all the essential documents up to date thereby reducing the monitoring time to an admirable extent.

Periodic reporting to Ethics Committee (SAEs, safety alerts, protocol deviations, trial progress etc.) as stipulated in the approval letter.

Internal pre audit Quality Assurance visit to site upon audit notification.

Keeping investigator sites ‘audit ready’ at any time-point. Our Clinical Research Coordinators (CRCs) conduct prior preliminary site review to make sure all documentation is complete and accurate and this helps reduce the frequency of visits from the CRO/Sponsor.

Our CRC’s assist with follow up and query resolution and thus save our clients’ precious time.