FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

Clinical Trials / Studies ~ FDA Consulting Services

At FDA Compliance Group, our FDA consultants have strong clinical experience, or have worked for the FDA. We also have an associate based in Florida who specializes in all aspects of monitoring and clinical study management.

We offer a range of consulting services, for all of your FDA regulatory needs, that covers the three cornerstones of FDA compliance: standardization, quality, and efficiency.

Standardization of Clinical Trials / Studies
We can advise you on all areas of clinical trial standardization, including: placement of an experienced, trained monitoring team, CRA (systematic monitoring methods and techniques for writing reports); and clinical study monitoring and management guidelines. We can also help you produce study materials for CRAs and CRCs.

Quality of Clinical Trials / Studies
We have expertise in GCP, ICH, and HIPPA, as well as GCP and SOP compliance. We can also provide assistance and training for CRA, PI, and CRC. We can facilitate investigator meetings and study initiation visits with comprehensive HIPPA and GVP / ICH education. Additionally, we can help you create Site Study Binders that include GCP / ICH action plans.

Efficiency of Clinical Trials / Studies
We can help you create efficient clinical studies through the use of web-based CGP / ICH and HIPPA education. We can also assist in implementation of eClinTMS (a trial management system for monitors), metric study planning, and eMonitoring Reports. We specialize in providing solutions that conform to FDA regulations and provide instant access to all information related to clinical trials.

For more information on FDA consulting services for clinical studies / trials or to schedule a consultation, please contact us.