Our Clinical Operation Service
We offer the expertise and exigence of MAJOR International pharmaceutical organisations tailored made to our Clients demand
Medical Writing
Delivering concise documents for all stages of regulations, project management, and final reports by combining medicine, science, technical, writing, and by collaborating with medical monitors, scientific experts and sponsors.
Trial Management
Clinical trials monitoring and management from feasibility to close-out visits of Mauritian, Réunion and western european sites, ensuring overall integrity of study implementation and adherence to study protocol.
Risk-based monitoring
Identifying problems and risks at trial sites remotely and initiating corrective actions, thus reducing time to complete trials, achieving faster time to market, and enhancing sales revenues.
Regulatory Affairs Activities
Site regulatory package preparation, submission to local/country specific EC and approval, collection of Regulatory documents.
Reducing Patient Burden with TELEVISITS
Assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity by Televisits with our registered Physicians, bilingual (French/English).
Project Management
Taking advantage of time management, communication and negotiating skills to pilot clinical trial, set milestones, analyse risk, and realise standard project planning and decision-making tools.