Trial design / protocol development

A key factor in achieving a successful clinical trial is to have a well-prepared, consistent trial design, protocol and Case Report Form (CRF).

Two main advantages of working with Cardialysis are their extensive experience in conducting clinical cardiology trials and the academic expert assistance they offer. These provide the sponsor with maximum efficiency in the trial preparation phase and an excellent start to the clinical trial itself.

Cardialysis established Standard Operating Procedures (SOPs) for the development of clinical study protocols and CRFs. These SOPs put a fundament to designing tailor-made protocols and CRFs that are compliant with ICH Good Clinical Practice and other clinical research regulations.

Design or Review

The services requested from Cardialysis differ among studies. Therefore, all Cardialysis project proposals are tailor-made. The same applies to study design, the protocol and the CRF. Although Cardialysis is experienced in designing protocols and CRFs from scratch, projects are also run with pre-designed protocols and CRFs from a sponsor. In such case, documents are simply reviewed for consistency with the activities  performed by Cardialysis.