Clinical Trial Project Management (Phase I - IV)

The development of a drug is a lengthy, costly and complex process, which may be referred to as project management.

What is a project?

A project is a defined piece of work which has agreed timelines and requires a team of people with diverse skills to work together to achieve a common set of objectives.

The scope of any project needs to be carefully defined from the outset and this is especially important if any part is to be outsourced. Definition of the project scope should clearly lay out the anticipated deliverables, timelines and cost estimates. A critical success factor in any project is having an appropriate “sponsor” who is of sufficient seniority to be able to exert influence at the cross-functional level. The sponsor needs to ensure that:

  • The project aligns with the business needs;
  • Key stakeholders are committed;
  • Sufficient resource is available, etc.

“Stakeholders” are those who will be affected by the project. They may benefit as a customer or be required to contribute as a resource provider. Stakeholders will be involved in key decision-making, e.g., stopping the project or approving major changes in its scope. Sponsors and stakeholders need to “own” the scope of the project, i.e. the definition of its boundaries. With the scope defined and stakeholder support in place, planning and scheduling can begin and thus a project can be executed to successful completion.

We at Consortium Clinical Research are experienced and understand the integrities that are involved in the ideal project management scenarios that are demanded from a clinical trial. With our technical competence and speed of operations, we ensure that each Sponsor is kept at peace and relaxed regarding the status of progress of the clinical trials that are undertaken by us to execute the functionalities of a Clinical Trial Project Management.

Information has been resourced from Principles of Clinical Research, 2001.