Project Management is essential during the lifetime of a project. A project manager ensures timely and appropriate communication on project matters within the project team and with stakeholders, ensures project/ study planning and execution, and performs risk management and budget management. At any time in the project, keeps the focus on the end result, on how to ensure that project deliverables are timely, within budget, and meet regulatory needs. Cardialysis offers project management services for pharma and/or medical device industry-sponsored trials (ISS) as well as investigator-initiated studies (IIS). Cardialysis’ project managers are very experienced; they are the linking pin between the project team at Cardialysis and our customers who value their project management skills, and especially their communication skills. They have proven to deliver net value to the projects (rather than cost), by mitigating risk before becoming an issue. 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 also acts as the primary contact for all sponsor decisions on timelines, quality and costs of the trial.
Speed and match are key for site selection. Whether the sites can be made available quickly, and whether they meet the requirements of the study (high quality, the requested patient volume, necessary equipment and expertise, motivated investigators and dedicated team) truly make a difference for project throughput time and cost containment. Cardialysis has close contact with over 1,400 cardiology sites world-wide, of which approximately 1200 in EU. These local teams only need specific protocol and procedural refresher training to understand what is needed.
One of the tasks in project management is the organization of meetings and conference calls to ensure good communication among 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 a 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 keeping a strong commitment of the investigators and help guarantee the high quality and timeliness for which Cardialysis is renowned. For example, the PM works with the Sponsor to ensure circulating newsletters at regular time intervals and depending on the size and scope of the trial, they can organize setting up a study website.