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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.

Clinical icons

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.

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 Zeneca, Dr. Otte is widely considered to be an industry leader in clinical development.

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​

Ilana Meskin​
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

Related Resources

 
Blog

Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation

May 17, 2021

Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug...

Submitting an IND application for the first time? Consider three common CMC pitfalls that may impact submission.

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E-Book

The State of Clinical Trial Activation at Sites Report

April 12, 2021

View our report on actions to streamline study activaiton and maximize operational efficiency.

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Blog

Defining Decentralized Clinical Trials and Understanding Their Nuances

March 24, 2021

Decentralization is one arrow in the quiver to modernize clinical trials.[1] Yet, owing to the varied approaches and possible components...

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.

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