Clinical Center of Excellence
Transform Your Clinical Performance
Advarra established the Clinical Center of Excellence to provide clients with the strategic advisory and operational support needed to innovate how clinical trials are designed, development and clinical operations are optimized, and how statistical, data, and pharmacovigilance strategies are effectively applied.
About Our Clinical Center of Excellence
Innovation. Optimization. Repeatable Success.
We are veteran industry leaders and clinical practitioners driven by a desire to help our clients achieve exceptional outcomes. We bring a multi-dimensional perspective to the clinical process to design more effective studies; save underperforming studies from a cost, quality or speed perspective; ensure pharmacovigilance compliance and patient safety; and continuously optimize organizational and process designs to increase probability of future success.
Tailored Consulting Offerings
Utilize trusted, independent expertise throughout the development process, and design innovative, effective trials to deliver an optimal patient experience.
- Guidance of critical assessments throughout research and development
- Clinical development planning
- Protocol development
- Statistical plan development
- Statistical and medical consulting of clinical trial data and results
- Independent asset reviews for critical “go/no-go” decisions
- Independent assessment of critical program challenges
- Expert advice on clinical trial disclosure and transparency
I found the experts to be a pleasant combination … not just a consultant with an outside view but also a colleague who wanted to contribute to and be part of the team and project success.
– VP, Development Operations
Proactively establish a solid clinical oversight management structure, mobilize flexible resources for key pain points, and quickly assess and remediate critical issues.
- Data strategy definition, quality review, and remediation
- Monitoring oversight
- Vendor model definition, selection, oversight, and issue resolution
- Patient recruitment and retention
- Operational expert resources for key project milestones
Advarra’s team went above and beyond the call of duty. The report, insights, and recommendations were extremely helpful in helping our team determine the best path forward for this critical asset.
– Director, R&D
Develop and execute against a pharmacovigilance (PV) strategy to ensure compliance and patient safety.
- Strategic guidance for establishing a PV organization
- Independent assessment of safety signals and issue management
- Vendor oversight support
- Technology evaluation and selection
The unique industry experience, flexibility and skill sets of Advarra’s experts resulted in a complementary partnership that was critical to advancing our client’s goals of safety compliance, while continuing to meet their high standards of support for their patients worldwide.
– Program Lead
- Build, retain, and optimize an efficient and qualified clinical organization.
- Strategic organizational design:
- Organization evaluation and design for optimization
- Merger and acquisition due diligence and integration
- New technology implementation
- Capability building:
- Mentor/coaching programs
- Build and standardize development and clinical trial processes
- Strategic selection of outsourcing models:
- Vendor selection and oversight
Engaging five objective experts injected fresh thinking and provided a unique opportunity to mine new ideas.
– Project Leader
Let Our Experience Be Your Advantage
At Advarra, we are more than regulatory experts. We are former executives and practitioners. We are professionals with deep experience getting life changing products into the hands of consumers and patients. We are FDA veterans with long-standing relationships.
We have worked across all therapeutic areas and classifications including 505(b)(2)s, new chemical entities, orphan drugs, generics, combination products, and more. We know what it takes to advance the drug development process. We stand ready to help you deliver.
A Snapshot of Our Clinical Expertise
Susan Buttler, BSc
Former Director of Clinical Program Management, Director of Clinical Research Contracting at AbbVie
Hugh Donovan, BSc
Former Executive Vice President, Clinical Research Services at Parexel
Karen Falkner, MSc
Former Vice President, Global Clinical Operations at GSK Vaccines
Jo Ann Horowitz, MD Oncology
Former Global Clinical Program Head at Novartis Oncology Global Development
Laura Lufrano, MSc
Former Vice President, Global R&D Operations at J&J
Margaret McShane, BS, MBA
Former Chief Operating Officer at Startup Biotech
Former Executive Director, Talent Management and Organization Development at Amgen
John Price, PhD, MB ChB
Former Vice President, Global Pharmacovigilance and Drug Safety at Alexion Pharmaceuticals
Louis Kirby, MD
Former Medical Director at Neuraltus Pharmaceuticals
Tom Stock, MD, Anti-Inflammatory, Immunology
Former Vice President – Global Head of Internal Clinical Research, Clinical Development and Operations at Pfizer
Pia S. Pollack, MD FACC CVS
Former Therapeutic Area Clinical Director, Cardiovascular & Metabolic Diseases at AstraZeneca
Steve Snappin, PhD
Former Vice President Global Biostatistical Science at Amgen
A Partner You Can Count On
“Advarra’s team went above and beyond the call of duty. The report, insights, and recommendations were extremely helpful in helping our team determine the best path forward for this critical asset.”
– Director of R&D
“The unique industry experience, flexibility and skill sets of Advarra’s experts resulted in a complementary partnership that was critical to advancing our client’s goals of safety compliance while continuing to meet their high standards of support for their patients worldwide.”
– Program Lead
“I found the experts to be a pleasant combination … not just a consultant with an outside view but also a colleague who wanted to contribute to and be part of the team and project success.”
– VP, Development Operations
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Submitting an IND application for the first time? Consider three common CMC pitfalls that may impact submission.
The State of Clinical Trial Activation at Sites Report
View our report on actions to streamline study activaiton and maximize operational efficiency.
Defining Decentralized Clinical Trials and Understanding Their Nuances
It’s important to understand decentralized clinical trials are not one-size fits-all and oftentimes a hybrid approach is necessary. Read our latest blog outlining what to consider when rolling out decentralized clinical trials across multiple jurisdictions where laws, technological uptake, and populations will vary.