> Research Service Providers
Clinical research is now its own eco-system where niche and non-niche providers work together to provide a variety of services. Sponsors must depend on CROs, who must in turn depend on large and small sites, SMOs, and academic medical centers to provide clinical trial support. CROs, sites, and sponsors are often experts in their core areas of expertise, i.e. managing clinical trials, recruiting appropriate subjects, and/or performing studies in accordance with appropriate GCP requirements. However, there are often areas that fall outside these core areas of expertise. At these points, sponsors, CROs, and sites routinely reach out to the the Firm for a variety of services including:
- Creating risk assessments based on current FDA, DOJ, HHS, and SEC areas of focus;
- Assisting in the creation, modification, and negotiation of Clinical Trial Agreements and Master Services Agreements between sites, sponsors, and CROs;
- Participating in and helping to ensure GxP adherence by creating SOPs and assisting with FDA inspections;
- Responding to FDA and non-FDA 483 and warning letters;
- Assisting in the recall of products that may be caused by non-compliant suppliers;
- Assisting in the development of FDA-compliant reporting of clinical trial results;
- Reporting and maintaining reports on clinicaltrials.gov;
- Assisting in the recording and reporting as required under the Physician Payment Sunshine Act and Anti-Kickback Laws.
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