Clinical operations

Our teams are involved at every stage, from creating the methodology to drawing up the overall budgets and cost schedules for the studies. Our specialists are also involved in the preparation and submission of regulatory documents to the relevant authorities, and support you in the selection and qualification of service providers.

IVIDATA Life Sciences supports you in all aspects of project management, including training and monitoring the project team. Our experts are also involved in coordinating the regulatory, operational, technical, and logistical aspects throughout the life of the project. Working alongside you, they will set up and monitor the deliverables, from implementation and monitoring activities through to study closure. We support you in the management of feasibility and centre selection studies, as well as for the drafting and management of study documents (synopsis, protocol, information and consent notes, etc.).

Our consultants can help you implement an appropriate risk analysis based on the nature and complexity of the project and the investigators involved. They will help you set up an appropriate monitoring plan (frequency of visits, percentage of VDS, type of visit between on-site and remote, and data criticality). Finally, they will set up and monitor performance indicators, along with regular governance to optimise all cross-functional activities (clinical operations, pharmacovigilance, data management, statistics, quality assurance, medical writing).