On Site Management

The practical implementation of the study protocol in experienced hands of study nurses


Our competencies

 

  • We have years of experience in the logistical planning and practical implementation of clinical studies of all kinds. We work according to defined processes (SOPs).

  • We have a basic nursing education and are trained according to uniform standards for the diverse activities in clinical research. We pass on our knowledge and experience to study teams.

  • We are recognized for our broad medical expertise and with each new study we work on new indications and therapeutic areas.

Our services

in the course of a clinical research project

studyphases

Typical phases of a clinical research project

 

CONCEPT phase

Usually, on-site management is not yet applied in the concept phase. However, it can be useful to discuss details of the planned study implementation with us at an early stage in order to clarify aspects such as logistical feasibility and the associated costs.


DEVELOPMENT phase

During the development phase of a study, the procedures of the study protocol are discussed in advance with you and all project partners. Afterwards, the detailed organizational and logistical work begins. We start with the preparation of the specific study documents for your study and check your test database in cooperation with Data Management.


SETUP phase

In the setup phase, we finalize all study documents based on the approved study protocol, create the Investigator Site File (ISF) or the Trial Master File (TMF) and prepare the initiation visits to your study centres.


CONDUCT phase

We accompany screening, information and inclusion of study participants and conduct study-specific training. We organize all study visits and ensure that your patients are admitted on time. Study specific samples are collected, processed, stored and shipped according to protocol. We take care of the timely delivery, storage and distribution of the study medication to your patients in accordance with the protocol. All study activities are continuously documented in the ISF and TMF. For drug accountability, we work closely with the hospital pharmacy.

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


COMPLETION phase

In the completion phase we finalize the complete study documentation at study center and prepare your study team for the close-out visit. In addition, we organize the archiving of all study documents and the proper destruction of study drug residuals.


More information

Study hotline
Tel + 41 61 328 66 11

If you have any questions regarding your clinical trial, please contact us by phone:

Mon-Fri from 9.00-16.00

Study consulting

For all questions concerning your clinical trial or research project, we offer project-related consulting services tailored to your needs. We consult experts from the individual services and formulate proposals for further action.