Project management

Clinical project management (CDM)

Our clinical project management solutions provide dedicated support for CDS-only work, from Early Phase to Phase IV, and expert Project Managers for safety and pharmacovigilance portfolio work, delivering consistency across programs and submissions, and covering all therapeutic areas and indications.

Who is a Clinical Project Manager?

A Clinical Project Manager (CPM) is someone who is in charge of overseeing all aspects of a project's effective inception, planning, design, execution, monitoring, and closure. The CPM may be hired for the full project or for certain portions of it. In order to ensure that your project is delivered on schedule and in a high-quality manner, it is essential for you as the sponsor to have a single point of contact for our entire team and the assistance of a seasoned CPM.

As all our project managers are strong leaders, they take care of your clinical research study to ensure its successful delivery. Transparency, accountability, and trust, along with clear communication, risk management, and effective escalation of information, are our key priorities.

Our clinical project management includes:

• Vendor oversight
• Ensuring all parties are well-informed throughout the study
• Implementation of the electronic data capture (EDC) system
• forms, and study files
• Establishing necessary documentation for regulatory and ethics committee approvals
• Development of clean file, study closure activities, and the clinical study report.
• Development of clinical project plans and timelines
• Site selection, Investigator meetings, as well as site training and documentation.
• Proactive risk management
• Preparation of study documents such as the clinical study protocol, informed consent and patient information, case report