Investigator Training & Education
Good Clinical Practice (GCP) and
Standard Operating Procedures (SOP) Training
According to the Harmonization for Better Health (ICH), good clinical practice is defined as, “the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs.
Our program for experienced investigators is focused on preparation for monitoring / regulatory audits and inspections. We also provide personalized training for established investigator sites seeking support in recruitment, enrollment, data entry & collection.
Logistics & Planning
- Selection of venue and meeting space
- Program Brochures and marketing
- Signage, printing, postage, mailing
- Audiovisual (screen, projector, television with VCR, flipchart, markers)
- Catering and menu selection
- Continuing Medical
Site Management Organization (SMO) and Investigator & Site Facilitation services
The site management processes and procedures are designed to address the Food and Drug Administration Safety and Innovation Act (FDASIA) that was passed in July 2012. Including:
- 907. Reporting of inclusion of demographic subgroups in clinical trials and data analysis in applications for drugs, biologics and devices.
- 1138. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented sub-populations, including racial subgroups.
Site Management Services Include:
- Investigator selection, qualification and recruitment
- Site start-up and training
- Clinical trial recruitment and enrollment
- Site regulatory compliance
- Monitoring and coordination of monitors
- Management of Adverse-event reporting