Trial Management

The highly specialized project management processes applied in clinical trials are designed to assure high quality standards throughout the trial lifecycle from start-up, conduct until closure. Navigating in the field of trial management is complex and intense, and it is easy to get lost or spend unnecessary large amounts of time and resources on follow-up and repetition if each and every step of the way is not properly conducted and documented.

Having gained insights from different fields within development and from various companies, gives me a broader perspective on where to focus resources and how to overcome challenges.

Examples of trial start up activities to be performed in close collaboration with your internal trial management team or CRO driven with me as your partner:

Project planning and budgetting
Stakeholder management - Facilitating timely decision making and reach milestones

Risk Management
- Identification and evaluation of risks associated with subjects safety and trial integrity, define mitigations and tolerance limits etc.
CRO management
- Sponsor oversight, performance tracking
Protocol Writing
- incl. related documents & regulatory submission support
Site selection support, investigator and site coordinator training, and development of patient recruitment and retention materials

Trial Management

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Having gained insights from different fields within development and from various companies, gives me a broader perspective on where to focus resources and how to overcome challenges.