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Safety management

 

Cardialysis offers Sponsors the full package of safety services needed and required for their trial. The Safety Team at Cardialysis is highly experienced, having processed ten thousands of adverse event reports from clinical trials with medicinal products, from clinical trials with devices and from treatment strategy trials. This includes commercially Sponsored trials, as well as Investigator Initiated trials. The Safety Team is highly flexible, which means they can work with all types of Sponsors,  Sponsor owned systems and procedures, or Cardialysis systems and procedures. The Safety Team is unique in their knowledge of the cardiology field, which ensures high quality data and fewer queries. The Cardialysis Safety Team collaborates closely with all other departments at Cardialysis involved in the trial, such as the  Data Management department, (local) monitors, Statistics, Medical Affairs and the Data Safety Monitoring Board (DSMB). This ensures efficiency throughout the duration of the trial and allows the Safety Team to be able to provide Sponsors with frequent data outputs to facilitate the legally required Sponsor oversight of patient safety.

Adverse Event Processing and Reporting

The Cardialysis Safety Team ensures that all AEs are processed in accordance with the legal timelines in the legally required format, applicable to the trial at hand. The Safety Team has the knowledge and the systems to ensure that USADEs/SUSARs/SAEs are reported in a timely and correct manner to Competent Authorities and Medical Ethics Committees in an expedited manner or in the applicable legally required periodic reports, such as the Meddev Line Listing of the DSUR. As the Safety Team uses a high-end safety system which ranks at the top of the field, more complex services can be offered additionally, such as signal detection and medical monitoring.

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.