Clinical studies

OUR EXPERTISE FOR YOUR PROJECT

TOGETHER TO YOUR STUDY

Interdisciplinary Consulting

We accompany you iteratively through the complete process and plan your clinical trial together. From conceptual design prior to application to implementation and evaluation: Our interdisciplinary team of experienced staff provides advice on both medical and technical issues. Transparently and in exchange with you, we jointly adapt the next steps and provide you with comprehensive support for your study, taking into account your individual needs.

Conceptual Design

We prepare everything that needs to be in place before the application stage

Conceptual Design:
Literature research, definition of objectives, selection of study locations

Goals and Biometrics:
Determination of the sample size(e.g. power analysis), determination of the study design and the inclusion and exclusion criteria

Process and Methodology:
Definition of the study procedure, selection of suitable methods and devices (e.g. for recording necessary measurement parameters)

Application Phase

We accompany the entire application and take over the communication with the ethics committee

Trial Documents:
Study plan, subject or patient information, consent documents, creation of data flow diagrams

Application and Registration:'
Data protection statement, submission of ethics application or request for a statement, registration in study register(e.g. DRKS)

Communication:
Iterative exchange with the ethics committee, authorities(if applicable), data protection and information security officers involved

Implementation

We assist with the preparation of the study forms, host your electronic Case Report Form (eCRF) and act as the investigator

Case Report Forms:
Creation of the case report forms(CRF), if necessary transfer to eCRF, e.g. for use in Open-Clinica.

Study Database:
Hosting of an Open Clinica database server for you(certified German data centre), maintenance/ security updates, support

InvestigatorActivity:
Depending on the particular study and subject risks, medical education, internal briefings of your colleagues and other medical tasks can be taken over by our experienced investigators

HERE WE CAN SUPPORT YOU ACCORDING TO YOUR NEEDS

Concrete work packages

Test plan

Literature research, determination of procedure, coordination with other centers, biometry, registration

Subject documents

Subject information, consent forms (additionally for assisted clients, if applicable).

Obtain ethics vote

Communication with ethics committee, responsible data protection officer, filing of applications

Case Report Forms

Define primary and secondary outcome parameters, create test forms (CRF).

Study database

Transfer paper CRF to electronic eCRF, set up, host and maintain Open Clinica server.

Investigator activities

After consultation with the ethics committee: investigator coordination, educational interviews

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