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Investigator Initiated Trials

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.
Investigator Initiated Trials

Definition

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 clinicaltrials.gov or clinicaltrialsregister.eu 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.

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.

Rheumatology
Urology
Hematology
Oncology

For further information please see our line of products

Application/ Applicants requirements

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

* Applicants eligible to apply are 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 CV.

Milestones

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:

* 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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