Consultancy

As a consultant, I can advise on the strategy and processes for conducting a study. Setting up or providing input on all the different study documents and processes, which are necessary for the proper conduct of the study. Or checking the proper conduct of a study ('inspection readiness').

Do you need support in setting up study documents, due to the high workload for the study team?

I have extensive experience in setting up all kinds of study documents. From drafting or reviewing a project plan, communication plan, monitoring plan or SDV guidelines, vendor management plan, pharmacy manuals, creating and reviewing patient information or recruitment materials. All study documents that you do not get around to, but which are crucial to have in order during the start of the study, I can help you with.

Do you want to check whether the study is 'inspection ready', do an independent check or check whether a study was conducted according to the corresponding processes?

I can offer support, in a review of, say, an (e)TMF, of the study team or site, or investigate whether the study is conducted according to protocols and procedures.

Finally, I offer support to a study team in setting up the agenda and content (presentations and training) of Investigator Meetings, so that the pressure on the study team does not increase.