Advarra Consulting combines strong technology and process improvement expertise with a deep understanding of the regulatory and life sciences environments to help move your research forward. Our experts will ensure your technology complies with the appropriate regulatory requirements.

Experienced Project Managers

Each client works with a senior-level staff member responsible for quality oversight of services, deliverables, and communications.

Proven Methodologies

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.

Assessment

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.

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.

Ready for Solutions That Are Altogether Better?

Tell us what you’d like Advarra to do for your research program.