Structure and Filing

(e)TMF filing and maintenance

Who works with clinical trials is aware of the fact, that it requires a lot of documentation, structure and filing. This is the most neglected task within the conduct of a clinical trial, yet it is of utmost importance and in not too rare occasions, you find yourself in a hurry to file and complete your binders when a Sponsor or local authority announce an inspection or audit. To prevent this from happening, it is important to keep your documentation tidy and up to date, as it is required by many companies to be „inspection ready“ at any time. 

To save your team from the stress it brings to keep your files tidy and actual, I am here to offer help and support you in documentation and filing and organize and structure your ways of documentation.

Please get in touch if you are interested in this service.