The Avoca Group is an industry leader and catalyst for change, transforming problems and issues into opportunities to create leading practice tools, guidelines, and standards that improve the speed, efficiency, and quality of clinical trials.
We help companies navigate the complexities of the clinical trial process to achieve optimal operational efficiency, enhanced risk assessment and mitigation, and to increase adherence to study protocol, regulatory requirements, and GCP and GxP standards.
Through membership in the Avoca Quality Consortium™, a member-based pre-competitive collaborative comprised of clinical operations, quality, and outsourcing professionals from pharma, biotech, CROs, and clinical service providers, companies gain access to an exclusive community that allows for greater cooperation, communication, and ultimately, collaboration – in the interest of improving the quality of clinical trials and getting medicines to patients faster.
Companies also benefit from Avoca’s consulting and research capabilities in the areas of relationship management, research, training, and identifying, and developing solutions to challenges found in managing quality outsourced clinical trials.
Additional Offerings Include:
ICH E6 (R2) GUIDANCE – Leading practices, guidelines, and tools including for ICH E6 (R2) compliance, inspection readiness, and risk management to increase efficiency and focus on critical activities including oversight.
OVERSIGHT CAPABILITY MATURITY (OCMM) – Helps companies manage providers’ ability to deliver on time, on budget, and with expected quality, which is increasingly important to ensure ICH E6 (R2) compliance.
PREQUALIFICATION OF TECHNICAL SERVICE PROVIDERS – Diligent™ accelerates the prequalification of technical service providers by leveraging prequalification tools and standards and accessing completed RFIs from 40+ vendors.
Certified by the Women’s Business Enterprise National Council (WBENC)
Avoca recognizes the commitment to supplier diversity embraced by corporations and government agencies today. The Avoca Group is certified as a women’s business enterprise by the Women’s Business Enterprise National Council (WBENC), the nation’s largest third-party certifier of businesses owned and operated by women in the U.S., and is proud to add diversity to supply chains.
Who We Serve
- Sponsors, CROs, and Clinical Service Providers
In the following roles:
- Clinical Operations/Clinical Development
- Clinical Quality Management/Clinical Quality Assurance
- Clinical Outsourcing/Procurement
- Vendor Management/Alliance Management
- Company Executives
- Clinical Trial Management
- Clinical Innovation
- Patient Engagement
- Site Level Managers
- Site Management
- Regulatory Affairs
- Heads of Business Development and Marketing
The Challenges We Help Solve
- Operational efficiency
- Quality Management
- Vendor Management & Oversight
- Decreased costs for drug development
- Changing regulations
The Avoca Group was founded in 1999 by Patricia Leuchten, who aspired to develop smart solutions to complex clinical trial challenges. From its inception, Avoca has guided companies through both proactive risk assessment and the implementation of quality-by-design, two measures that have become more important in recent years as complexity has increased.
Through the development of the AQC, Avoca is helping companies avoid costly and time-consuming delays due to quality management and/or non-compliance issues.
Across 18+ years of industry research and consulting, Avoca has built a storehouse of data continuously updated by experienced industry experts, and kept the industry informed on the evolution of outsourcing through their annual Avoca Report.
Patricia Leuchten has more than 25 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing and strategic alliances.
Contact us to learn more.
Some of our clients include:
- Abide Therapeutics
- Bristol-Myers Squibb
- Celtic Pharma
- CR Bard
- Eli Lilly
- Endo Pharmaceuticals
- Ferring Pharmaceuticals
- Johnson & Johnson
- J&J Pharmaceutical Research Development
- Novo Nordisk
- Ortho Biotech
- Ortho Clinical
- Purdue Pharma
- The Medicines Company
- Aptiv Solutions
- CRF Health
- ICON Clinical Research
- INC Research
- inVentiv Health Clinical
- Longboat Clinical
- Medical Research Consultants
- PRA International
- Quest Diagnostics Clinical Trials
- Schulman Associates IRB
- TKL Research
- Worldwide Clinical Trials