Our offer

Estimation of effort and feasibility

In the concept phase of a study, it may be useful to discuss the details of the planned study implementation with us in order to clarify aspects such as logistical feasibility and the associated costs.

Logistical planning and study documents

Together with you and all project partners, we plan all processes according to the study protocol and work out the organisational and logistical details. We start with the preparation of the specific study documents and create the Investigator Site File (ISF) or the Trial Master File (TMF).

Furthermore, we prepare the initiation visit for your study centers and check your trial database in cooperation with the Data Management.

Patient management and study medication

We accompany screening, consent and inclusion of study participants and conduct study-specific trainings. We organise all study visits and ensure that your patients are called in on time.

Study-specific samples are collected, processed, stored and shipped according to protocol. We take care of the punctual delivery, proper storage and protocol-compliant dispensing of study medication to your patients. We continuously document all study activities in the ISF or TMF. For drug accountability, we work closely with the hospital pharmacy.

Monitoring visits

We help with the careful preparation and follow-up of monitoring visits to ensure that your study run as smoothly as possible.

Documentation and study closure

We finalise the complete study documentation of the study center and prepare your study team for the close-out visit. In addition, we organise the archiving of all study documents and the proper destruction of residual stocks of study medication.

Medical Monitoring and MedDRA coding.

Our service includes the medical assessment of the study protocol for feasibility and a pre-trial risk analysis. We review the AEs/SAEs documented in the (e)CRF and make the medical interpretation of the data in exchange with the investigators. In addition, we can take over the coding of the safety reports according to the MedDRA terminology.

By collecting, processing and archiving relevant safety information, we guarantee the individual monitoring of patient safety in your study. On request, we also write reports and documents for sponsors and authorities.

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Tips & Support

Are you new as a Study Nurse at the USB and would you like to get trained?

The Study Nurses at the DKF offer courses on an individual basis. The time required is 4 hours twice.

Make an appointment

Are you looking for examples and instructions for forms, checklists, plans and logs?

We provide over 40 templates for documents, checklists, and guidance from On Site Management.

Request access

Are you looking for SOP templates?

We provide over 30 templates for work processes from the conception to the completion of a clinical trial.

Request access

How to reach us