Clinical Trials FDA Consulting Services

At FDA Compliance Group, our clinical FDA consultants have strong industry clinical experience, or have worked directly for the FDA.

We offer a wide range of clinical consulting services, for all of your clinical FDA regulatory needs including IDE, Sponsor, Principal Investigator, GCP, IRB, etc. We offer assistance with protocol development, consent forms, CRFs, clinical trial monitoring, data monitoring, pre-submission meetings, PI recruitment, safety reports, SAE, UADE, IRB approval/renewal, TMF, clinicaltrials.gov listing, SOPs, SIV, training, data monitoring plans, site closeout, statistical data analysis and report writing, etc.

Our clinical consulting services cover the three cornerstones of FDA compliance: standardization, quality, and efficiency.

Standardization of Clinical Trials and 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 and 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 and 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.