Project Management:

Since projects are usually unique, temporary and complex assignments, the risk of failure or disinvestment is very high. Therefore BTC handles projects as Risks and every action within a project is based on that awareness. The best way to cope with risk is to create open communication with the project sponsor based on mutual trust and respect. When both parties are aware of this complex matter, expectations can be managed throughout the project in order to celebrate a successful outcome at the end of the project.

BTC uses a methodology based on joint experience with colleagues project managers from all over the world, built up in many years. This methodology can be recognised in certification programmes like IPMA (B-level) and PMI (PMP level).

Before a project can start, the different steps of Requirements Engineering must be performed and a Project Plan will be set-up. This plan will contain the following chapters:

1.      The Requirements Specifications, covering the problem analysis, all demands, wishes and the constraints (depending on the type of project, the Requirements of other aspects in the solution may also be documented). All (known) Business Risks will be reported, accompanied by suggestions for approach or provisions to manage them;

2.      The Project Approach, covering all project risks and all necessary phases with activities to be performed, including the activities necessary to cope with some of the project risks;

3.      The Project Constraints, including the desired project organization, the necessary skills and tools and the procedures in order to cope with the remaining project risks;

4.      The Project Schedules (time lines) from where negotiations take place with the sponsor in order to get an agreement on a final Project Plan with commitment from all parties involved.

After commitment is achieved on the plan, the execution of the project may start and the plan will be used to:
a.      Communicate tasks and responsibilities to the project members;
b.      Manage and control the progress of the project;
c.      Communicate the progress and the conclusions to the stake holders;
d.      Manage the expectations of the stake holders.

During the closure phase of the project we evaluate both the outcome for the sponsor and the project management process in order to improve the project management approach.

Especially for the pharmaceutical industry, a training project management is developed to improve the quality of trial management! Adjustments on that training are used for all other functions within clinical research.

If you would like to know more about project management in general, or about the project management training in particular, please contact us, we will reply soon.