A Trusted Partner for
Clinical Excellence

Innovation. Optimization. Repeatable Success.

Transform Your Clinical Performance.

YourEncore established our Clinical Center of Excellence to provide clients with the medical, statistical strategic advisory and operational support solutions needed to innovate how clinical trials are designed and managed. 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 studies that may be underperforming from a cost, quality or speed perspective; ensure pharmacovigilance compliance and patient safety; and continuously optimize organizational and process designs to increase the probability of future success.


Proven Solutions

Drug & Device Development Consulting

Design innovative, effective trials that deliver an optimal patient experience.

Rely on trusted independent expertise for critical assessments and guidance throughout the development process.

Clinical development planning


Protocol development


Statistical plan development


Statistical and medical consulting of clinical trial data & results


Independent asset reviews for critical “Go/No-Go” decisions


Independent assessment of critical program challenges


Expert advice on clinical trial disclosure and transparency

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Clinical Trial Oversight & Remediation

Proactively establish a solid clinical oversight management structure.

Mobilize flexible resources for key pain points.

Quickly assess and remediate critical issues.

Data quality review & remediation


Monitoring oversight


Vendor oversight & issue resolution


Patient recruitment & retention:

– Vendor selection
– Advice on specific tools & technologies
– Program assessment


Product supply chain & delivery


Operational expert resources for key project milestones

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Pharmacovigilance Planning & Compliance

Develop and execute against a pharmacovigilance strategy that ensures compliance and patient safety.

Strategic guidance for establishing a PV organization


Independent assessment of safety signals and issue management


Safety case management and reporting


Support for vendor oversight


Technology evaluation and selection

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Organization Design & Optimization

Build, retain and optimize an efficient, qualified clinical organization.

Strategic organizational design:

– Organization evaluation and design for optimization
– M&A Due Diligence & Integration
– New Technology Implementation


Capability building:

– Mentor/coaching programs


Build & standardize clinical trial processes


Strategic selection of outsourcing models:

– Vendor selection & oversight

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Let Our Experience Be Your Advantage

At YourEncore we are more than clinical experts. We are former executives and practitioners. We are professionals with deep experience and a relentless focus for continuous improvement.

We understand your challenges and partner to deliver solutions that are customized to fit your unique needs. We know what it takes to advance the drug development process. We stand ready to help you deliver.

PRINCIPAL, CLINICAL CoE

Dr. Adrian Otte
Former VP of 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.

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A SNAPSHOT OF OUR CLINICAL EXPERTISE

Kelly Vaillant
Former Global Head of Clinical Trial Disclosure & Transparency at Gilead Sciences

Hugh Donovan
Former Executive Vice President, Clinical Research Services at Parexel

Robert Pennington, MD
Former Lead Product Safety Physician at Celgene

Eric Chojnicki, Ph.D., MBA
Former Senior Director, Portfolio & Project Management at Neurotech USA

William Gannon Jr, MD
Former CMO at Apthera

Sunil Jain
Former AVP – Program Head at Biocon

Suresh Aravind, MD
Former Worldwide Vice President at J&J


A Partner You Can Count On

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