Phase II-IV Clinical Trials:
Clinical Trial Management and Monitoring

Regulatory Affairs
The RCRS Regulatory Affairs team has considerable global experience in drug development and regulatory strategy. This enables its clients to most efficiently develop their new drugs and to achieve timely and successful regulatory submissions. RCRS has experience in drug development throughout the world, with focus on the US, EU, India, Middle East, and other Asia-Pacific countries. RCRS is able to provide regulatory liaison services including agency interactions of all types such as responses to agency requests for information, planning and preparations for successful scientific advice development meetings, and preparation and submission of documentation for clinical trial and marketing applications that meet all international requirements.

Based on the extensive knowledge of the regulatory environment and the changing requirements in many countries and regions, RCRS is able to provide strategic input, advice and services that are valuable to companies of all sizes. RCRS can provide input on documentation and agency interactions regarding exploratory INDs, fast track development, orphan drug classification, priority review, conditional approvals, regulatory gap analysis of development plans, labeling negotiations, risk management plans, and Advisory Committee Meeting support.

RCRS also has considerable global experience in clinical trial support including interactions with ethics committees, import and export licenses of trial materials, certified qualified staff for manufacturing and drug supply issues, legal representation where the company does not have a country office, submission of required trial documentation, investigator packages, Investigator's Brochure development (to ICH GCP standards), safety reporting, and annual reports.

RCRS is also able to provide significant lifecycle management support for its clients, including regulatory strategy to expand the market for an approved product by identifying new indications and dosage forms, and aiding the client in meeting all regulatory requirements such as submission of spontaneous adverse event reports to regulatory authorities, submission of Periodic Safety Update Reports, review of promotional materials to meet agency requirements, review of label changes, marketed product annual reports, manufacturing changes, and submission of post-approval commitments.

In summary, RCRS serves the entire spectrum of regulatory needs for its clients, based on experience and knowledge.

Grant & Investigator Payments
The familiarity with the local legal and regulatory environments allows RCRS to efficiently create and manage Investigator contract and payment schedules that abide by local laws and appropriate agencies. RCRS also distributes and monitors Investigator grant and payment schedules for the Sponsor.