Cardialysis Data Management and Logistics provides a variety of services. All services are targeted on the quality, consistency and completeness of the data.
Central Tracking System (CTS)
The Central Tracking System is a sophisticated automated system for tracking all pre-defined activities within a trial and complies with the Cardialysis Standard Operating Procedure (SOP). The tracking system is attached to the main trial database to monitor the day-to-day progress of the trial. It is also used to generate reports that are sent to the sponsor on a regular basis.
In every trial, a number of databases needs to be developed. The Cardialysis departments for ICT, Statistics and Data Handling work together to develop tailor-made databases for every trial.
The valuables of a clinical trial are the data gathered. Handling has to be done by a well-trained and organised department like the Data Handling Department of Cardialysis. The department has short communication lines to the Clinical Research Associates and Clinical Trial Managers. Data are double data entered in the database by teams that work on specific trials and perform specific activities. Error checks are generated on the basis of a detailed checklist and later used for generating automated edit queries.
Patient Allocation Service
If a Central Allocation Service is used, Cardialysis develops the procedure for patient allocation and maintains contact with this service. If a Central Allocation Service is not used, Cardialysis keeps track of all patients included in the trial by regularly entering allocation information received from the site into the central tracking system.
In complex trials, the investigators appreciate the opportunity of having a second opinion from a cardiologist. If requested, 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.
Serious Adverse Event (SAE) Reporting
Cardialysis reports all SAEs to the sponsor within 24 hours or on the next working day enabling the sponsor to notify the competent authorities within the stipulated time window. Cardialysis will collect all event-related documents, write event narratives and provide these to the sponsor.
Data Safety Monitoring Board (DSMB)
Data safety monitoring is the assessment of general trial progress, the safety data, and the critical efficacy endpoints by an independent DSMB comprising 3–5 experts. In consultation with the Steering Committee and the sponsor, Cardialysis appoints the DSMB members, assists with the development of the DSMB procedures, organises the DSMB meetings, and provides the DSMB with safety data during the recruitment phase of the trial.
Event Adjudication Cardialysis is accustomed to setting up and running the entire event adjudication process: from preparing the event dossiers to organising the Clinical Event Committee (CEC) who will adjudicate the events. The web-based adjudication system offers numerous advantages, one of the most important being the immediate availability of the results.