Our offer

Project partners and funding applications

Tailored to your project, we support you in identifying project partners. We take on the role of a central coordination office and help out in the preparation, coordination and timely finalisation of funding applications.

Study protocol

We work with you to develop the study protocol, including flow charts and graphical representations. We support you in writing study-specific documents (essential documents) such as patient information sheets, worksheets and logs.

Contracts and submissions

We help you to find out which contracts are necessary for your study and provide you with the appropriate document templates. We can take over the contract negotiations and coordinate the parties involved with the legal department. We support you in applying for the appropriate patient insurance policies and assist you in the preparation of national and international submissions.

Estimation of recruitment numbers

We advise you on the estimation of achievable recruitment numbers so that your study can be carried out in the planned time and within the planned budget. In addition, we provide you with practical tips and assistance for the successful recruitment of your study participants.

Training of the study team

To initiate a study center, all members of the study team must be trained regarding their responsibilities, the procedures and all documents. As representatives of the Sponsor-Investigator, we are happy to provide this training at the individual study centres.

Central coordination office

On your behalf, we ensure that everything runs as smoothly as possible. To this end, we keep an eye on the key data of your project: recruitment rate, timelines, budget and timeliness of documents, and intervene if necessary.

We coordinate the cooperation of local and decentralised project partners and take responsiblity for the information and communication to all parties involved, e.g. in the form of study-specific newsletters. In multicenter studies we assist in the planning and organisation of investigator meetings.

Finances and budget

Upon request, we take over the financial accounting of your study including invoicing as well as payment assignment and overview.

Data Safety Monitoring Board

We organise and accompany the Data Safety Monitoring Board (DSMB) of your study. A DSMB assesses the safety of a study intervention during the ongoing study. We support you in the preparation of a DSMB-Charter, provide templates, organise all meetings and provide meeting reports.

Final report and presentation of results

We offer assistance in preparing a final report for your study according to the standards of "ICH E3 -Structure and content of clinical study report". For projects that are managed by us, we also assist in the preparation and submission of posters for presentation at conferences.


For more information

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Tips & support
 

What are "Essential Documents" according to ICH GCP?

Here you will find a comprehensive list with descriptions of the respective function of each document.

More information


You have staff shortages?

We can temporarily take over the project management of your study.

Submit a request
 

You want to make sure that you will be able to recruit a sufficient number of patients for your study?

We have compiled a catalogue of measurse and provide support.

More information

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Free-of-charge for DKF research groups
 

  • Support und Management von Data Safety Monitoring Boards

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