Clinical Trials Activities
We can advise you on the most adequate trial design for the specific development stage and goals you are targeting. Optimal design often meets with cost-effectiveness and rapid achievement of CE mark and/or reimbursement.
We can draft your clinical trial documents, in English or in French and supervise translation through certified medical translators in most EU local languages with native medical speakers control.
We have a large experience in EC and CA study submissions in most EU countries, ensuring study initiation within optimal timelines. We can also deliver all monitoring tasks from study/site initiation to study/site closure, in most EU locations, through native, experienced CRAs under optimal management, through a single VP-level supervision, and to the highest GCP and regulatory standards.
We have strict processes and manage our CRAs in a thorough and effective manner. Our team members have the highest ethical standards, are trained to up-to-date GCP and regulatory processes, we have our own SOP coverage but can work per Sponsor SOPs as needed.
We have a track record of GCP and regulatory training capacity, targeted both internally and to Site/Sponsor staff. Our General Manager acts as a key trainer in various EU venues and e-learning organizations.
We have a track record of CEC and DSMB global management, ensuring adequate and unbiased adjudication of events and tracking of safety processes. Our prior experiences in CEC and DSMB management have won us KOL as well as Sponsor trust and respect.