Experienced Project Managers
Each client works with a senior-level staff member responsible for quality oversight of services, deliverables, and communications.
Advarra brings hard-earned insight and knowledge to your research practice and programs, customizing each solution to specific client needs.
Regulatory and Development Expertise
With a deep understanding of security best practices, regulatory requirements, and software and products, our experts will help your organization implement compliant, effective technology solutions.
Ensuring Part 11, GDPR, and HIPAA/HITECH Compliance
With the growing prevalence of technology in research, compliance with 21 CFR Part 11, Annex 11, HIPAA, and GDPR is increasingly critical in research, but many organizations do not have a deep understanding of these regulatory standards.
Advarra’s experts take your organization through a 3-step process to build a risk-based program, ensuring compliance now and in the future.
Training and Education
Our proprietary training curriculum prepares your organization for the rigors of compliance with Part 11/Annex 11, HIPAA, and GDPR. The training covers all aspects of preparation and compliance and delivers sample assessment documents.
Undergo a rigorous assessment to reveal any gaps in compliance before an inspector does. You receive a detailed report outlining your level of compliance with the regulatory frameworks and recommendations for remediation.
Advarra’s Part 11 and computer system validation team can help you remediate issues found during our assessment. Let our team provide the training, procedures, and expertise to prepare you for success.