Project Management is essential during the lifetime of a project. A project manager ensures timely and good communication on project matters within the project team and with stakeholders, they ensure project/study planning and execution, they perform risk management and budget management. At any time in the project, their focus is on the end result, on how to ensure that project deliverables are timely, within budget, while ensuring that deliverables meet regulatory needs. Cardialysis offers project management services for clinical trials & projects sponsored by industry (pharma and medical devices) as well as investigators (investigator sponsored studies – ISS). Cardialysis’ project managers are very experienced; they are the linking pin between the project team at Cardialysis and our customers. Their project management skills, and especially their communication skills are valued by our customers. They have proven to be very valuable to the projects, by preventing issues rather than solving them. They do this together with our customers and our internal project team members.
Conducting clinical trials requires experienced and committed human resources. 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 Project Managers is appointed. The appointed Project Manager leads a Cardialysis Project Team and coordinates all contact between the investigators, committee members, sponsor representatives and local monitors in a smooth and client-friendly way. He or she is also the primary contact person for all decisions made with the sponsor on timelines, quality and costs of the trial.
For site selection, two factors are really important: whether the sites can be selected quickly, and whether they meet the requirements of the trial (high quality, the requested patient volume, necessary equipment and expertise, motivated investigators and dedicated team). Cardialysis has close contact with over 1,400 cardiology sites world-wide ensuring quick site selection based on the highest quality possible.
One of the tasks in project management is the organization of meetings and conference calls to ensure good communication with all parties. 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 and Steering Committee meetings are often organized near the congress venue.
Manuals and Documents
Apart from the protocol and CRF, all kinds of documents need to be developed to comply with research guidelines, rules and regulations and to ensure smooth and fast progress of the trial. Experience and clockwork organization are the keywords in this part of project management at Cardialysis. In close collaboration with the sponsor, the Project Manager takes a leading role in 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 ensure that the sponsor stays informed and help 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. In addition to this, newsletters are drawn up together with the sponsor, and circulated at regular intervals to keep the site study team updated on the trial. Depending on the size and scope of the trial, a study website can be set up.