> 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.

Do you want to focus on your competencies and have a Firm that augments your core competencies to focus on the areas of non-interest? Contact the Firm today.

Disclaimer: The material on our website has been prepared and published for informational purposes only. There is no effort or intention to solicit new clients or new engagements from existing clients by way of this website, nor should any of the information published on the website be construed as representing any of our lawyers' availability to practice in jurisdictions where they are not authorized to do so.

None of these materials are offered, nor should be construed, as legal advice. Communication of information by or through this website and your receipt or use of such information is not intended to create an attorney-client relationship with the Kulkarni Law Firm, P.C. or any of the Firm's attorneys. The creation of the attorney-client relationship would require direct, personal contact between you and the Firm through one or more attorneys and would also require an explicit agreement by the Firm that confirms that an attorney-client relationship is established and the terms of that relationship. You should not act or rely on information contained in these materials without specifically seeking professional legal advice.