• Pharmaceutical / Biotechnology / Biologics
  • Clinical Trials
  • Manufacturing
  • Health Care Compliance
  • Pharmacovigilance and Safety Plans (REMS)
  • Supply Chain / Subcontractor Management
  • Ethics & Corporate Responsibility
  • Case Studies
• Medical Device
• Health Care
• Energy
• Engineering & Construction
• Manufacturing & Services
• Government & Non-Profits

Kaplan EduNeering assists organizations in the pharmaceutical, biotechnology and biologics industries to accelerate pre- and post-marketing clinical trials while maintaining regulatory compliance and safety standards. Our GCP curricula are developed in collaboration with the US FDA and regularly updated to reflect the most current regulatory requirements and guidance.

Our solution enables defensible recordkeeping that minimizes the potential for error, protects study-related compliance data, and achieves cost-efficiencies in the management of multiple, dispersed study sites. Because our solutions are hosted, external investigator personnel and internal employees can attain the same information online - any day, any time -- that was delivered in-person at investigator meetings including GCP, protocol, and EDC training.

Among the challenges Kaplan EduNeering has helped clients address:

• Global study compliance across multiple clinical study sites including Electronic data capture (EDC) training & Good Clinical Practices (GCP)
• Protocol understanding among sponsor, site, and CRO personnel
• Targeted Role-Based Curricula Directed to the CRA, CRC, and Investigator
• Distribution and documentation of clinical study communications (safety updates, protocol amendments, etc.)
• Cost-effective implementation of Phase IV studies