Our trainers have worked in the FDA and major pharmaceutical corporations, functioned as Coordinators and Principal Investigators, managed quality assurance units, directed regulatory compliance programs, and managed multiple clinical trial and data management centers. We support on-site and off-site seminars and conferences of all sizes, to include planning, organizing, executing logistical details, and customized document preparation.
We offer the following Training and Education services:
• 21 CFR Part 11 Compliance • Basic and Advanced GCP • Clinical Data Management 101 • CRA Training • Essentials of Clinical Trials • FDA Inspection Preparedness • Data Safety Monitoring Workshops • Advanced Training • Oracle Clinical Basic and Advanced Training • Oracle Remote Data Capture (RDC) • Oracle Thesaurus Management Systems (TMS) • Oracle Adverse Event Report Systems (AERS) • Oracle CDISC Training • Oracle Database Administration