Investigator Initiated Studies
What is an Investigator-Initiated Study?
An Investigator-Initiated Study (IIS) is a research effort in which the researcher/investigator designs and implements the study. In these studies, the investigator acts as the Sponsor, assuming all of the regulatory responsibilities typically performed by pharmaceutical manufacturers. An IIS may be supported by Meda in the form of either funding and/or company product; however Meda may not provide regulatory, legal or clinical support.
Meda's Areas of Interests:
Meda will evaluate research interests that may include clinical, preclinical and in-vitro research that can expand the understanding of Meda's respiratory products.
What are the responsibilities of the investigator?
Including but are not limited to the following:
How to Apply
- The Investigator-Sponsor is responsible for designing, implementing and conducting the investigation
Visit the FDA Investigator-Initiated Investigational New Drug (IND) Applications Page
- Administering investigational product
- Assume all Regulatory obligations of both the Sponsor and the Investigator in accordance with applicable laws, regulations and guidelines
- Complying with institution requirements where the study will be conducted and all relevant laws, regulations and guidelines for clinical and pre-clinical research
- Reporting safety data to regulatory authorities and to Meda, as required
- Providing Meda with interim and final research summary reports, a proposed publication plan and a draft manuscript(s) as applicable
Be sure to carefully read the below detailed information about MEDA's IIS process and guidelines before submitting an IIS request.
You may submit an online application at http://www.medapharma.us/iis/apply.php
The following documents are required at time of application:
What is the review process?
- A completed IIS Request Form
- A study protocol or proposal that includes, at a minimum, the study objectives, background and rationale, supporting literature, disease stage, clinical population description and size, and study plan
- Investigator CV
- Itemized budget [when funding is requested]
- Form W-9 Request for TIN [for US studies]
Who can I contact if I have questions?
- All submitted requests will undergo an internal review by Meda's IIS Review Committee consisting of company personnel from relevant disciplines.
- By accepting IIS requests, MEDA does not imply or guarantee that the IIS request will be approved.
- A decision is based on strategic fit with Meda's areas of interest, investigator research experience, scientific merit, adherence to Good Clinical Practice, etc.
- You will receive written notification of the IIS Committee's decision upon completion of this review. However, MEDA is under no obligation to provide an explanation for its decision.
- If your proposed study is approved for Meda's support, an IIS study agreement will be provided to you to sign as a requirement to execute prior to study start.
For additional information, Contact MEDA's IIS Office at:
265 Davidson Ave.
Somerset, NJ 08873