- Determination of the size / scope of the project
- Division in various stages
- Implementation of the various stages
- Follow-up of the project progress
- Decision-making and final product
An important condition for a project to succeed is an enthusiastic and motivated
project team. Passion4Projects can build such a team and keep them enthusiastic and
committed so results can be achieved within the time limits.
During 15 years of project management, many studies were initiated and carried out.
The size of the trials varies from a few dozen patients to thousands in various fields
such as cardiology, psychiatry, vaccination and dermatology. The study team consisted
of 2 to 18 persons in the functions project manager, CRA, CTA, data manager and analyst.
Passion4Projects supports all steps of project management and can also support in
recruitment and selection of a project team
Passion4Projects can assist in all aspects of monitoring:
- Site selection
- Pre-study visits
- Initiation visits
- Organising of start up meetings
- Monitoring and documenting the visits
- Drug accountability
- Close-out visits
- Set up and keeping up to date of the study file
Due to strict rules and regulations, there is much administration and paperwork involved
in the conduct of clinical trials.
Passion4Projects can offer a helping hand with:
- CCMO submission
- Central and local METC submission
- Writing of patient information and informed consent
- Creation of the study filing
- Writing of standard operating procedures
- Design of Study Forms.
Coaching and training:
In the field of coaching and training we can support in the training of project managers,
CRA’s and CTA‘s.
You can think of:
- GCP training, including European clinical trial directive and Dutch legislation
- SOP training
- Co-monitoring visits
Where necessary, Passion4projects will seek for cooperation with other freelancers
in the same discipline so that the highest possible quality will be offered.
Of course this is done in consultation with the sponsor.