Safety reporting

The Safety Team at Cardialysis closely collaborates with local monitors, our Data Management department and the Data Safety Monitoring Board (DSMB). An efficient process has been established for adverse event reporting. Our team has in-depth experience in cardiology, resulting in cleaner data, fewer queries and high-quality reporting to Competent Authorities and Medical Ethics Committees.

Serious Adverse Event (SAE) Reporting

Cardialysis collects and processes all SAEs, including event-related documents, writes event narratives and provides these to the sponsor.

Cardialysis reports all SAEs to the sponsor within the agreed timelines so that the sponsor can in turm submit the relevant SAEs to the Competent Authorities within the stipulated time window. Alternatively, Cardialysis can perform direct submission to the Competent Authorities on behalf of the sponsor.

The Safety Team at Cardialysis has processed over 10,000 SAEs since 2012 (from both drug and device trials combined). Cardialysis has a flexible team and works according to internal or sponsor procedures. All safety-related tasks and responsibilities are documented in a Safety Reporting Plan.

Data Safety Monitoring Board (DSMB)

The DSMB is responsible for ensuring the safety of the patients participating in a clinical trial. In addition, the DSMB monitors the endpoint data and provides recommendations on the continuation of the trial and/or modifications to the protocol that may be necessary to maintain the safety of the patients. To contribute enhancing the integrity of the trial, the DSMB may also make recommendations related to the selection, recruitment and retention of the patients, patient management, improved adherence to protocol-specific regimens, and the procedures for data management and quality control.

A DSMB typically consists of 3 to 5 members, and has the expertise required for the clinical trial concerned. Cardialysis appoints the DSMB members together with the Steering Committee and sponsor, develops the DSMB procedures, organizes the DSMB meetings, and provides the DSMB with safety and efficacy data during the execution of the trial.

Clinical Event Adjudication

Cardialysis is accustomed to setting up and running the entire event adjudication process: from preparing the event dossiers to organizing the Clinical Event Committee (CEC) that will adjudicate the events. The web-based adjudication system offers numerous advantages, one of the most important being the immediate availability of the results.

Hotline Service

In complex trials, the investigators appreciate the opportunity of having a second opinion from a cardiologist. Cardialysis can offer a 24-hour telephone service staffed by medical experts to answer trial-specific (medical) questions from the research team at an investigational site.