Project management is at the heart of KYomed INNOV’s expertise. In our “Clinical Evaluation of Innovative Devices” department, your solution is handled by a dedicated project manager who oversees the entire evaluation.
Complete oversight of your clinical evaluation
Having defined the framework and the protocol of your clinical evaluation, the person in charge of your project at KYomed INNOV (an experienced project manager in clinical research) manages for you the whole investigatory process:
- assess the study’s feasibility and establish a timetable for it,
- select the clinical investigation centers or medical experts,
- participate in the selection of any external resources,
- coordinate all stakeholders,
- set up a regulatory dossier and manage the submissions to all the competent authorities,
- draw up contracts with medical investigators or medical experts, as well as recruited health establishments,
- supervise the operational follow-up and keep you informed of the progress of your study at regular and defined intervals,
- supervise or undertake monitoring visits to the clinical centers,
- manage the schedule and logistics of the evaluation,
- manage and ensure respect of the evaluation’s defined budget,
- organize, build, maintain and archive the evaluation’s administrative dossier,
- draft the clinical report at the end of the evaluation.
Information, traceability and flexibility
Thus, we take care of all contacts, negotiations, exchanges with all the stakeholders involved in your investigation and we are committed to keeping you regularly informed of its progress. “We make a point of liaising closely with our customers throughout their project, in order to inform them, as well as to keep tuned to their needs since these can evolve through time” says the Business Development Manager.
Moreover, as an integral part of your clinical evaluation, KYomed INNOV guarantees the quality, traceability and confidentiality of the data collected.