AmeRuss’s expert staff has conducted Investigator Initiated (Sponsored) Studies (IIS) in US and Europe and, since 2012, in Russia/CIS. AmeRuss’s experience in IIS includes the various disciplines of rheumatology, neurology, neurosurgery and cardiovascular surgery. Using an established algorithm for project development, AmeRuss can manage investigator initiated trials related to most nosologies, whether national or international, single site or multicenter in scope, for both pharmaceutical and medical device companies.
During 2014-2015, AmeRuss plans to conduct more than 20 IIS studies under the auspices of Russian American Consortium for Excellence in Rheumatology (RACER, http://racerlink.org/) in Russia and USA.
The full package of activities is covered by AmeRuss professional approach tailored specifically for IIS. The scope of IIS study conduction includes the following steps:
- Signing of Consultancy Agreement
- Carrying out all necessary meetings with KOLs/Sponsor in order to formulate the main study concept, its targets and objectives, to determine the scope of work and required resources, estimated study results, sample size calculation, study timelines, etc.
- Detailed project budget development and signing of Master Agreement
- Medical Writing of all clinical study documents (protocol, Investigator Brochure (IB), CRF, ICD and others)
- Regulatory submission of documents to National Regulatory Authorities (if applicable) and to Ethic Committees/IRBs (if applicable)
- Conclusion of all necessary contracts with investigator sites, investigators/physicians, patients. Payment fulfillment in accordance with contracts
- Project monitoring, Data Management and Biostatistics
- Final study report writing
- Assistance in official scientific publications in local and international specialized magazines. Presentation of results at the professional congresses and conferences
Where sale and marketing may be supported through the conduct of IISs, AmeRuss is ready to facilitate trial execution effectively with the Supplier/Manufacturer and investigator.