The study start-up phase in any clinical trial is crucial and time consuming. A key challenge in conducting clinical trials is that they typically span a variety of stakeholders, including study sponsors, contract research organizations (CROs), site management organizations (SMOs), investigators, study teams and patients. Timely completion of study-start up activities such as the collection of essential documents, translations, submission to ethics review committees and the regulatory authority, ensures a quick trial initiation. RemediumOne has an excellent track record of initiating a number of studies successfully in the country, and with a team dedicated solely to handle start up activities, we have often initiated sites within 6 months of the study being awarded to Sri Lanka.

Feasibility

Regulatory affairs

Startup

Safety reporting

Admin and logistics

Site space management

Project management

Quality management

Recruitment and retention

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Quick startup timelines in the region

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20 weeks Feasibility to FPI