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Background / Rationale

To promote the translation from preclinical findings into clinical contexts, the BIH has established a comprehensive translational research and development environment.

For this translation to be successful, the robustness of preclinical studies is pivotal. Responsible PrecliniX at the BIH QUEST Center extends the existing ecosystem and is connected with multiple stakeholders in translational research - like the BIH Core Facilities, the Research Facilities for Experimental Medicine, the Clinical Study Center, and the regulatory affairs representatives - to bring together complementing expertise and ensure and provide guidance for robust evidence generated from preclinical research. 

Aims

Responsible PrecliniX aims to assess and improve preclinical research to generate patient-informed and robust evidence, in order to ensure high research standards, clinical relevance, and consequently iterative translation, i.e., from bench to bed and back. 


Our services for you

The figure below provides an overview of how Responsible PrecliniX can support your research project.

General project overview and needs assessment 

In order to get an initial, general overview of your project or needs, we offer the following:

  • Assessments like Status Quo or Self-Assessment. For details, see the SOP workflow
  • Metric based evaluation, done by us based on the information you share with us
  • Project specific SWOT (strengths, weaknesses, opportunities, threats) analysis
  • Identification of action items 
  • Improvement with action plan

For an initial consultation, please fill in our entry form.


Specific support

We support projects from the research question to publication and clinical implementation, and offer different services within the research process. You can find an overview of the specific support services in the table below. 

Table
Planning experiments Stakeholder mapping e.g., Core facilities, Clinical Study Center, animal welfare officer, regulatory affairs
  (Systematic) reviews Rapid literature screening, connection with CAMARADES Berlin*, critical appraisal of preclinical model
  Experimental design Hypothesis, model planning (critical appraisal of experimental models), target parameter,j sample size calculation, control groups, randomization, blinding, data storage, definition of inclusion/exclusion criteria
  Animal permit application Incl. refinement (collaboration with FEM), guidance/support (incl. biometrical form)
  Preregistration Identification of suitable platform(s), guidance/support
Conducting experiments Protocols/SOPs Development, harmonization, publishing (e.g., protocols.io**)
  Streamlining of processes Communication processes
  Documentation of research results e.g., via ELN***
  Practical assistance in the in vivo area Lab visits to tailor experimental design based on existing infrastructure
Evaluation of results Data analysis Application of inclusion/exclusion criteria (outlier management), visualization of data/experimental design, meta-data
Reporting Data sharing open access/open data
  Platforms Guidance/support, dealing with null results
  Reporting guidelines e.g., ARRIVE, RIVER
From bench to bedside - next steps Product specific "Fit for purpose" Target-Product Profile (TPP), investigator brochures, regulatory requirements/refer project to regulatory support unit
     

*CAMARADES Berlin
**protocols.io
***ELN

 
PREMIER: a modular quality assurance system 

In addition to consulting services, we support you with a modular quality assurance system that is specifically tailored to basic research: PREMIER. With PREMIER, we provide you with freely available tools, such as an anonymous error reporting system (LabCIRS), a research wiki and various templates (e.g., for SOPs, experimental design etc.)


Further Activities of RPX

Events and trainings

  • Responsible PrecliniX is present in several events to introduce how robust evidence can be obtained from preclinical experiments aiming at translation.
  • We are also developing a train-the-trainer program to empower research groups to employ responsible research practices across all projects. 


SPARK

  • Responsible PrecliniX is part of the SPARK program mentoring meetings. To find out more, click here.


Meta research

  • RPX is also coordinating and performing research on research (meta-research) projects. 


Contact

If you are interested in hearing more about these offers, please write us an email.

Any research group, researcher, postdoc, or doctoral student is invited to contact us with questions in these areas. We are happy to advise and support you at any time.

For an initial consultation, please fill in our entry form.

Responsible PrecliniX FAQ

Funder and cooperation partner

Contact

  • [Translate to englisch:]

    Dr. Natascha Drude

    Research fellow - Responsible PrecliniX

    Contact information
    Phone:+49 30 450 543 454
    E-mail:natascha-ingrid.drude@bih-charite.de
  • Dipl. Biochem. Claudia Kurreck

    Quality manager | Project manager - PREMIER (Experimental Neurology at Charité and BIH QUEST Center)

    Contact information
    Phone:+49 30 450 560 664
    E-mail:claudia.kurreck@charite.de