FDA Regulatory Compliance Services

Independent review of clinical trial documentation, including source documentation, to assure compliance with FDA and ICH regulatory requirements, SOP's and clinical trial protocol; review for trials subject to additional NIH and/or HHS regulations are available for an additional charge

GCP, GMP and GLP audit & education

Client support in clinical trial protocol, protocol amendment and investigator brochure authoring

Client support in the design of clinical trial documentation forms; specialists in consent documentation

Client assistance with IND, TIND, NDA and IDE submissions

Client support with IRB submissions

Client support in the selection, training and evaluation of an IRB

Client preparation for on-site FDA, NIH or HHS visitation: The "mock visit" service

Beginner, intermediate & advanced clinical trial compliance education

CRA (clinical research associate) training

CSC (clinical study coordinator) training

Provision of nterim CRA and CSU staff

Provision of sceening services of potential clinical trial participants (inclusion/exclusion)

Provision of Pharmacovigilance/Adverse Event Reporting services & training; narrative specialists

Provision of MeDRA coding & training

Training on HIPAA compliance in the clinical research setting; assistance with implementation and evaluation

Client support with post-marketing FDA regulatory compliance

Additional services available