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Global Consulting Powered By Experience

Organized around four Centers of Excellence: Quality, Regulatory, Clinical, and Institutional Research, Advarra Consulting experts work directly with your team to accelerate product development and performance, making clinical research safer, smarter, and faster.

Our Centers of Excellence

Quality Center of Excellence

Grow in Confidence

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Regulatory Center of Excellence

Mitigate Risk

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Clinical Center of Excellence

Build Repeatable Success

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Institutional Research Center of Excellence

Transform Your Research Administration, Compliance, and Operations

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Results-Driven Approach

Effectively blending industry best practices; tested, proven methodologies; and a successful history of client engagements to deliver optimal outcomes.
  • Industry best practice​s
  • Deep client experience​
  • Proven methodologies

Center of Excellence Leadership

Joan Versaggi, MBA
VP & Principal, Quality CoE

Former Director – Research Laboratories Program Realization Office-Sigma, Merck

With over 35 years of global experience in the pharmaceutical industry, Joan Versaggi has a diverse range of quality, compliance, clinical and business process improvement consulting knowledge and expertise.

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Joseph Lamendola, PhD

Principal, Regulatory CoE

Former Vice President, US Regulatory Affairs at BMS

With over 30 years of leadership experience, Joseph Lamendola advises companies on all key agency interactions, including pre IND, end of Phase 2, pre NDA and advisory committee meetings. Lamendola also advises on regulatory structure and process, as well as alignment between regulatory, clinical, and commercial drug development processes.

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Adrian Otte, MB, BCh
Principal, Clinical CoE

Former Vice President, Global Development Operations at Amgen

With over 35 years’ experience leading Global Clinical Operations at companies such as Pfizer, Amgen, Parexel and AstraZeneca, Adrian Otte is widely considered to be an industry leader in clinical development. Otte is recognized for his ability to develop strong, diverse teams of talented individuals who share his passion for drug development and relentless focus on continuous improvement.

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Cheryl Byers, MHA, CIP, CHRC ​

VP & Principal, Institutional Research CoE

Former Director, Protocol Review & Monitoring Systems and Regulatory Affairs, Moffitt Cancer Center

With over 20 years’ research compliance experience, Cheryl Byers is an expert in human subject research. She provided oversight to programs such as pre-clinical, conflict of interest, HIPAA privacy, research misconduct, institutional biosafety, radiation safety, export control, and facility security. Byers is a former AAHRPP site visitor and step 1 reviewer; is certified in healthcare research compliance; and is a certified IRB professional.

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Why Advarra?

1,000+ consultants
Providing expertise across four Centers of Excellence
25+ years
Average industry experience
6 continents
Experts located across the globe
20+ years
Serving clients worldwide

Related Resources

 
White Paper

Understanding the RTF Letter

July 23, 2021

Understand what the refusal-to-file (RTF) process is and what the Food & Drug Administration (FDA) is looking for.

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Info Sheet

Strategic Organization Transformation Info Sheet

July 23, 2021

Advarra’s Strategic Organization Transformation solutions help R&D organizations optimize or transform key elements of their operating model.

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Info Sheet

Independent Asset Review Info Sheet

July 23, 2021

Advarra's independent asset reviews effectively test critical assumptions and strategies related to the Phase III transition process.

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