The Project Management Team follows Global Project Management techniques and constitutes of highly experienced, client oriented personnel offering project management support to Investigator Sites and Sponsor's.
Our Project Management Team, for each study, takes complete ownership of the study assigned to them. The Team will interact with you to understand your protocol specific requirements. On the basis of these requirements, we would set up the study database in the Centralized Laboratory Information Management System at our Central Laboratory in Mumbai. On receiving the intimation of the study initiation, we would coordinate with the Investigator Sites & your Project Team to ensure a smooth management of your study until its data lock.
The Project Executives carefully review the study protocols with respect to the set-up of the study along with the financial proposal for the services to be rendered to support the study. During the study initiation process our Project Executives would organize meetings with you for discussions on the protocol. They would also discuss protocol revisions if any with you, make the necessary changes in the set-up if required, address any concerns or your queries and conduct periodic reviews to evaluate the satisfaction of our service levels.
Our Project Executives
- Provide primary communication with the sponsors after the study has been awarded to us
- Set up the study database in our Centralized Laboratory Information Management System
- Develop study-specific test requisition forms to capture the demographics, visit type, laboratory investigations and related clinical information
- Design study specific Instruction Manual for investigators detailing, the visit schedule, specimen collection kit contents, specimen collection and processing instructions, shipping instructions, reporting information, reference ranges and contact details
- Closely coordinate with the Data Management Team for the Electronic Data Transfer set up to facilitate transfer of laboratory data electronically
- Serve as a single point contact for the sponsor and the investigators
Clinical Research Coordinators
The Project Executives are assisted by a team of trained and qualified Clinical Research Coordinators.
Our Clinical Research Coordinators:
- Facilitate daily study monitoring
- Check the Test Requisition form for subject demographics for any incomplete or conflicting information and generate problem data clarification form
- Coordinate with the investigators sites to seek clarifications on problem data and problem specimen generated for the study
- Manage site supplies and maintain the inventory
- Address queries raised by sponsors, investigators & monitors within a defined time frame
- Assist the Investigators in arranging for courier pick up of specimens for the study
- Ensure the delivery of laboratory reports via fax, email & courier to the Investigators, Sponsors & Monitors
- Telephonically intimate the Investigator sites regarding the critical call outs, alert and exclusion comments for the study subject
- Check the blinding of specific parameters in the laboratory report as specified in the protocol
- Check the applicable delta flags for the study