Welcome to Mitsubishi Tanabe Pharma America's Independent Research Program Portal
Mitsubishi Tanabe Pharma America, Inc. (MTPA) is committed to supporting independent research initiatives that foster the advancement of scientific and clinical information and improve patient care. The Independent Research Program (IRP) has been created to provide support for Investigator-Initiated clinical research or Health Economics Outcome Independent Research that illustrates the potential to foster knowledge and understanding of MTPA’s product Radicava® (edaravone). Support from MTPA may be provided as funding and/or study drug.
MTPA will receive and review applications for independent research conducted in the United States in the therapeutic area of Amyotrophic Lateral Sclerosis (ALS) in the following arenas:
- Clinical research in patients diagnosed with ALS receiving or evaluated for Radicava® (edaravone) treatment
- Health Economic Outcome Research proposals in patients diagnosed with ALS, receiving or evaluated for Radicava® (edaravone) treatment
- Maximum duration of study must be 2 years with MTPA Independent Research Review Committee interim review at the end of every 12 months.
- MTPA financial support can be requested for permissible research expenses capped at $100,000.00 per application research site/per year with an additional maximum 25% overhead cost allowed, excluding equipment purchase.
- Research drug-supply (Radicava®) may also be requested. Alternatively, research patients receiving Radicava® as part of their routine clinical care will not be provided with study drug. No placebo drug-supply will be made be available through MTPA.
- The final approved protocol must adhere to Good Clinical Practices including all applicable laws, regulations, codes and guidelines and Pharmacovigilance & Product Complaint reporting must adhere to MTPA’s policies and SOPs and applicable laws and regulations.
- The external investigator is responsible for the planning and execution of the study. Any publication, as deemed appropriate by the investigator, is the responsibility of the investigator and the authorship group he/she selects (per ICMJE and GPP3 requirements).
All applications will be reviewed for scientific merit, innovation, clinical impact on patients, and compliance with MTPA policy and requirements. Applications will be approved at MTPA’s sole discretion. At this time, any incomplete application or application in the following areas will not be considered for review:
- Pre-clinical research
- Clinical research already being planned or sponsored by MTPA
- Continuing Medical Education (CME) or other educational activities
- Event sponsorship
- Research supported by patient or advocacy organizations
MTPA’s Independent Research Applicants are required to comply with all applicable laws, regulations, rules, and industry codes related to clinical and/or non-clinical research.
To submit a request, please first create an account using the 'Register for Access' Link on the left. If you already have an account, please enter your login details to the left. The link contains detailed information on the submission process, including the submission fields to complete to finalize your application. All required submission fields must be complete, and requested documents uploaded, in order for MTPA to consider your application for review.
Applications are reviewed on a bi-annual basis. The deadline for submission for this application period is Friday, September 7th 2018. Once an application is approved, the Investigator will be notified via email within six (6) weeks following the submission deadline.
NOTE: All Proposals must be submitted via the MTPA online IRP application portal. Hard copies will not be accepted. The next request for application period will be Winter 2018.
The information and/or requirements of the IRP are subject to change at any time at MTPA’s sole discretion. MTPA has no obligation to approve applications received.
To contact the Mitsubishi Tanabe Pharma America team:
For Technical Support, please contact SteepRock Client Services:
Phone: +1 718-576-1406 (M-F 8am - 6pm US ET)