Providing our clients with clinical research consulting and outstanding strategies to ensure ICH/GCP compliance.
A company with over 13 years of clinical research experience, dedicated to providing unsurpassed results to the pharmaceutical industry.
What we offer to our clients:
*Monitoring and auditing of multiple investigational sites in a variety of therapeutic areas in accordance with State and Federal Regulations, Good Clinical Practices and client's Standard Operating Procedures.
*Conducting site audits and/or resolving audit findings.
*Performing quality assurance monitoring visits to ensure completeness and accuracy of efficacy and safety data as well as to ensure all GCP issues have been reported and handled appropriately in accordance with the monitoring plan and client's SOPs for Phase I - IV studies.
*Reviewing protocol violations with investigators and taking corrective actions to ensure future compliance.
*Providing onsite training per SOPs |
