Good project management is essential for running clinical trials efficiently. A few important project management activities are listed on this page.
Conducting clinical trials is people business. Regardless of whether the trial involves 50 or 10,000 patients, as soon as a sponsor decides to work with Cardialysis one of the experienced Clinical Trial Managers is appointed as Project Manager. The appointed Clinical Trial Manager sets up a Cardialysis project team and coordinates all contact between the investigators, committee members, sponsor representatives and Clinical Research Associates (CRAs) in a smooth and client-friendly way. He or she is also responsible for all agreements made with the sponsor on timelines, quality and costs of the trial.
In site selection, only a few factors are really important: whether the sites can be selected quickly, and whether they have the right requirements (high quality, the requested patient volume, necessary equipment and expertise, and motivated investigators). Cardialysis has close contact with over 1,200 cardiology sites world-wide ensuring quick site selection without compromising quality.
One of the tasks in project management is the organisation of meetings, which involves the preparation, participation in and reporting of meetings. These can be Steering Committee meetings, sponsor meetings or investigator meetings. Since most sponsors and investigators are present at all major cardiology congresses, the investigator meetings are often organised during these congresses. This reduces costs and increases the involvement of the investigators in the trial.
Manuals and Documents
Apart from the protocol and CRF, all kinds of documents need to be developed not only to comply with research guidelines, rules and regulations but also to ensure smooth and fast progress of the trial. Experience and clockwork organisation are the keywords in this part of project management and both apply to Cardialysis. In close collaboration with the sponsor, the Clinical Trial Manager is responsible for the development and maintenance of numerous manuals and critical documents.
Cardialysis offers its customers different types of reports to keep all parties up-to-date on the status of the trial. These reports not only keep the sponsor informed but also help to keep the commitment of the investigators at the highest possible level. Cardialysis considers these reports as an important instrument in guaranteeing the high quality for which Cardialysis is renowned, and for staying within the requested timelines.