Investigator Initiated Trials

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


At medac we define Investigator Initiated Trials as unsolicited research initiated, developed and sponsored by independent/non-pharmaceutical researchers. An IIT is a clinical or non-clinical study performed without the involvement of medac, for which the IIT sponsor is responsible for understanding and complying with any and all regulatory requirements related to the research conducted. 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 or or other accessible databases.

medac does not serve as the regulatory sponsor for IITs. The study sponsor has complete responsibility for study conception, design, operational execution, data handling, data analysis and evaluation, subsequent reporting, and ensuring compliance with all local laws and regulations.


Unsolicited request submitted

Unsolicited request submitted

  • Protocol / Synopse
  • Curriculum Vitae (CV)
  • Application form (below) submitted
  • Type and amount of support requested
  • Budget scheme (in case financial support is requested)

medac review of IIT proposal

medac review of IIT proposal

  • Aim of the study
  • Study design
  • Treatment / assessment schedule
  • Endpoints / Objectives
  • Budget / costs of study
  • Feasibility
  • Medical-scientific evaluation

Study set-up

Study set-up

  • Contract
  • Sponsor: EC / IRB approval
  • Sponsor: CA approval (if needed)
  • Study medicinal product shipment

Active study

Active study

  • Executed according to protocol and contract
  • Quarterly updates of enrollment / progress
  • Sponsor: SAE reporting

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 its boundaries.

Autoimmune diseases

For further information please see our line of products


Application / Applicants requirements

The requirements set forth by medac must be met by each applicant:

medac Review

As part of our governance system we will review and evaluate each received proposal within approximately two months. Principles that govern evaluation of IITs include:

medac requires sponsors/investigators to apply for support via an online application process. Applications received through other means will not be considered for review.


If you have any question, feedback or encounter technical difficulties please do not hesitate to contact us via

Apply here:

Investigational product
PDF upload

* = mandatory

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