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Investigator Initiated Trials

Investigator Initiated Trials

Investigator Initiated Trials (IITs) are recognized as a pivotal pillar of driving medical research. We see IITs as an important aspect to contribute towards enhancing understanding of medac’s products and their therapeutic value. Hence, we are looking forward to receiving and evaluating your proposal and to enter discussion about possible support.
Investigator Initiated Trials

Definition

At medac, we define Investigator Initiated Trials (IITs) as unsolicited research projects initiated, developed and sponsored by independent/non-pharmaceutical researchers. An IIT is a clinical or non-clinical study conducted without medac's direct involvement, for which the IIT sponsor assumes full responsibility for understanding and complying with all applicable regulatory requirements . The IIT sponsor requests medac to provide either funding, drug product (provided as finished medicinal product) or both pursuant to a written agreement. All studies supported by medac must be registered at clinicaltrials.gov or clinicaltrialsregister.eu or other accessible databases. medac does not serve as the regulatory sponsor for IITs. The study sponsor has full responsibility for study conception, design, operational execution, data handling, data analysis and evaluation, subsequent reporting, and ensuring compliance with all local laws and regulations.

Main areas of interest

The main focus of medac's operations is on the below listed indications. Yet, if you cannot find your area of research, we still encourage you to submit your IIT request as medac is interested to explore further indications and is constantly expanding scope of interest.
  • Rheumatology
  • Urology
  • Hematology
  • Oncology

For further information please see our focus areas

Application/ Applicants requirements

To be considered for funding from medac, applicants must meet the following requirements:
  • Applicants must be physicians, pharmacists, or
    researchers, as appropriate to the nature of research for which
    support is sought.
  • Applicants must be qualified by training and experience to 
    perform the proposed research.
  • Applications are to be submitted via application form including
    information for all fields highlighted as mandatory.
  • For financial support a budget plan needs to be submitted.
  • Applicants must provide a current Curriculum Vitae.

Please find here the application form for an Investigator Initiated Trial (click and you will be directed to this page). 

Milestones

medac review

As part of our governance system we will review and evaluate each received proposal within approximately two months. The following principles guide the evaluation of IITs:
  • The adherence of the IIT being conducted to highest ethical and
     scientific standards as stipulated by the International Council of
     Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
  • The focus of the IIT on ensuring patient safety is of paramount
     importance.
  • The integrity of the scientific question being addressed.
  • The alignment of the IIT with the company defined areas of
     (strategic) interest.
  • The gain in knowledge about the safety and efficacy of our products.
  • The robust nature of the IIT design.
  • The commitment of the sponsor to divulge the results of the IIT
    in an appropriate and transparent manner.
  • medac requires sponsors/investigators to apply for support via
    an online application process. Applications received through other
    means will not be considered for review.

Please find here the application form for an Investigator Initiated Trial.

If you have any question, feedback or encounter technical difficulties, please do not hesitate to contact us via IIT@medac.de 

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