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
Regulatory Center of Excellence
Clinical Center of Excellence
Build Repeatable Success
Institutional Research Center of Excellence
Transform Your Research Administration, Compliance, and Operations
Effectively blending industry best practices; tested, proven methodologies; and a successful history of client engagements to deliver optimal outcomes.
Industry best practices
Deep client experience
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.
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.
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.
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.
Introduction to Advarra Consulting
Our experts work directly with your team to accelerate product development & performance, making clinical research safer, smarter, and faster.
Understanding International Data Transfer’s Impact
Read our blog to understand some of the data privacy implications facing international clinical research.
ReadyQMS Info Sheet
Advarra ReadyQMS, a quality management system for biopharmaceutical companies, reduces risk and ensures regulatory compliance.