About us

Our Mission

To be the premier clinical research organization providing early phase Clinical Development services to the biotechnology industry

Our Focus

Ce3 provides support and services exclusively to biotech companies. We specialize in early phase oncology development, and can manage your studies from First In Human (FIH) to accelerated approval.

A specialized CRO for biotechs

We know and understand the biotech environment! Our experience allows us to quickly adapt and deliver on the evolving needs and new requests that are inherent to growing companies.

Our high-touch, proactive approach to clinical trial execution, coupled with our refined processes and technology, allow Ce3 to support clients in the most cost-effective and efficient manner – enabling you to have access to your data early to make the necessary data-driven decisions throughout the study.

Our goal is to deliver quality data faster, easier, and better than our competitors to facilitate timely decisions to meet biotech and investor needs.

Our success is supported by:

  • Infrastructure and streamlined processes that allow flexibility and customization
  • Tools and technology to create efficiencies and promote cost savings
  • Experience needed to provide creative solutions and risk mitigation
  • Streamlined communications and transparency to simplify client interactions and oversight
  • Our partnership philosophy and team approach
  • The leadership required to manage and coordinate teams to deliver on time with quality

 

Our specialty is oncology

Early phase oncology studies require agility, customization, and attention to detail.  Our team is responsive and adept at managing the inevitable challenges inherent to clinical trial.

The evolving drug development paradigm in oncology is resulting in more complex study designs. Now more than ever, Sponsors need a partner that can be flexible and nimble  – not rigid or bureaucratic. The ability to be flexible is central to every aspect of our business.  Whether your regulatory strategy is to achieve breakthrough designation, fast track or accelerated approval, we will align our operations to support your goals.

Our oncology experience includes:

  • Immuno-oncology (inclusive of cell and gene therapies)
  • Hematologic Malignancies
  • Solid Tumors

Ce3’s memberships include:

Meet the team

Our leadership and infrastructure support ingenuity, transparency, and excellence.

linkedin iconHolly Coulter

President and CEO

linkedin iconTimothy​ Garrelts

Chief Operating Officer

linkedin iconDeborah Church MD

Chief Medical Officer

linkedin iconSusan​ Albert BSN, MBA

Head of Strategic Operations and Relationships

linkedin iconPatricia​ Edwards BSN

Director, Clinical Operations

linkedin iconMelanie​ Dyer

Director, Data Management

linkedin iconLydia​ King PhD

Director, Biostatistics

linkedin iconDarshan Kansagara CSSBB

Director, Clinical Programming

Interested in joining our team?

History

Since inception, Ce3 has concentrated on thoroughly understanding the needs of small biotechnology companies and has offered a more collaborative approach with quality services and cost-effective solutions to support our clients’ regulatory and investor goals. We have refined and leveraged our tools and skills to easily accommodate the special requests and customization required by the dynamic biotech environment. 

2005

Founded by industry professionals with a deep understanding of clinical drug development focused on clinical trial execution

2006

Added medical writing and medical monitoring services

2008

Added biometric services

2010

Added quality management services

2012

Strategic partnerships with Phase 1 Unit, European CRO, Clinical Pharmacology and PV providers

2015

Ten year anniversary

2018

Consolidation of biometric services, addition of specialty oncology providers

2019

Added pharmacovigilance services

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We provide ballpark costs for your clinical development planning