Trial design / protocol development

The 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 its extensive experience in clinical cardiology trials and academic expert assistance. This gives the sponsor maximum efficiency in the trial preparation phase and an excellent start to the clinical trial itself.

Cardialysis has established Standard Operating Procedures (SOPs) for the development of clinical trial protocols and CRFs. With these SOPs, Cardialysis is able to design tailor-made protocols and CRFs that are compliant with Good Clinical Practice guidelines and other clinical research regulations.

Design or Review

The services requested from Cardialysis differ from trial to trial. Therefore, all Cardialysis project proposals are tailor-made. The same applies to trial 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 the sponsor. In this case, documents are simply reviewed for consistency with the activities that will be performed by Cardialysis.