About Us

A competitive edge that amplifies value

Ce3 is a contract research organization specializing in early phase clinical trials. Ce3’s extensive experience in clinical trial management has lead to success in many challenging therapeutic areas, including oncology and infectious disease as well as gene therapy in urological and cardiovascular indications. Furthermore, we have rescued projects mid course, offering cost-containment solutions that bring them back on track.

Our Philosophy

    The Ce3 Management team endeavors to provide the Biopharmaceutical industry with quality resources that are rich in experience.

    Our talent is in getting to the core of our client's expectations, and delivering on those expectations in an efficient and cost effective manner.

    Since 2005, we have been successful in our efforts as evidenced by our repeat business. We firmly embrace the belief that our client's success is our success.

Our Culture

At Ce3 we don't just focus on business plans and strategies. We also focus on what it feels like to work here. We like an informal, non-bureaucratic environment where there is easy and significant interaction with senior leadership, and where creative ideas with merit are entertained rather than pushed aside in deference to the status quo. As a result, our culture is a blend of intensity and caring.

We especially celebrate diversity in people, but also in ideas, work style, and even our approach to the challenges for which we create solutions. Diversity is a significant and valued asset, and as such it is carefully cultivated and protected within our company.

We strive to maintain a culture of openness, in which everyone is a valued contributor and feels comfortable sharing ideas and opinions, and we encourage interactions within and across teams, so that working together is a pleasure instead of a burden.

Our People

The Ce3 team is characterized by competence, purpose and integrity driven by our passion for people and progress, we are intense about our work, but we're also caring and fun, and enjoy one another. We respect individual talent and contribution but always demonstrate interdependence and genuine team spirit. We want to make a difference, by ourselves and as a team, and we help each other achieve success.

We are entrepreneurs at heart who don't shy away from hard work. We want to enjoy day-to-day life at our company. That means we want to know that with skill and hard work, we can make a real difference here, and that we'll be supported in our efforts and recognized when we make that difference.

Our Commitment

Ce3 and its employees are dedicated to a cleaner environment and the preservation of natural resources at home and at the office. We continuously strive to find ways to recycle and reduce energy consumption by actively recycling materials related to work and personal use, employing energy efficient lighting and company policies aimed at reducing waste, our reliance on paper and investing in alternative energy and clean air technology.

Inclusion

Ce3 is an equal opportunity and affirmative action employer. We especially celebrate diversity in people, but also in ideas, and work style. Diversity is a significant and valued asset, and as such it is carefully cultivated and protected within our company. Ce3 offers a stimulating working environment, that values innovative ideas and encourage employees to strengthen skills and gain valuable experiences that help them grow professionally and enable them to excel in their everyday functions.

Employee Health and Wellness

At Ce3 we feel that our employees are our greatest assets. We support, inspire and care for each other, we encourage one another to adopt or maintain healthy lifestyles that promote physical and emotional health.

Good Corporate Citizenship

At Ce3 we are passionate about our commitment for innovation and science, the success of our clients, and ultimately the patients in need of new and effective treatments. Operating ethically is the only way we know how to work, assessing our activities to ensure that what we are doing is not only beneficial to our clients and employees but also our environment, and our community. Ce3 employees are involved in many charitable organizations by working as volunteers, advocates and supporters. Our efforts cover a wide spectrum of health, social, and environmental issues. Ce3 supports these activities by raising awareness and through corporate donations.

Ce3 stands for
Collaborative, Experience, Efficiency, and Excellence.
These qualities represent the core values of our company
and are the foundation for all that we do.

Services

We provide biotechnology companies with regulatory submission services and early phase clinical trial execution.


Project Management

    Ce3 project managers are experienced team leaders focused on providing on-time, on budget results, whether managing a single service or a full-service clinical program. Our project managers develop a strong relationship with you and your team based on clearly identifying and mutually agreeing to all study objectives.

    Ce3 Project Managers:

    • Serve as a primary resource and point of communication for the project team
    • Provide leadership and direction to the project team and our clients
    • Ensure Ce3 systems and processes are adhered to assuring both efficiency and accuracy throughout the project
    • Review and monitor study quality metrics
    • Employ an active risk management perspective to resolve issues with thoughtful consideration
    • Manage proactively, being flexible in their approach without compromising SOP compliance

Clinical Study Monitoring

Ce3 CRAs are experienced monitors and are fully trained on all aspects of each program's design, objectives, and challenges to ensure consistent communications with our sponsors. We have a strong concentration in Oncology with a depth of experience that allows our monitors to ramp up on assignments rapidly.

CRAs communicate regularly with Investigators and investigative sites to verify patient enrollment, review study progress, answer protocol questions, discuss CRF completion and ensure the study is moving forward on time and as planned. Our CRAs are intimately involved in the data review process so their commitment to data quality impacts them directly.

Medical Management & Safety Reporting

Ce3 has medical resources on staff, and can provide full Medical Monitoring services. An experienced physician provides medical consultation and support to our clients, Ce3 clinical development staff and the study site staff. The Medical Monitor works closely with the Project Manager concerning all medical and safety issues to ensure adherence to all reporting requirements for adverse events. Ce3 can report all serious and/or unexpected adverse events directly to our clients or to appropriate regulatory authorities, as necessary.

Study Quality Metrics

The complexities of drug development and clinical study activities require constant monitoring of numerous key variables to assure adherence to project timeliness and provision of high quality data. Ce3 continually measures key variables and metrics of each study it conducts. We continually seek ways to improve the results we deliver to our sponsors.

Study Quality Metrics provide Sponsors with quantifiable measures of study progress and provide the Sponsor and Ce3 study management team with tools to work together to ensure the delivery of services and the highest of quality data products that meet or exceed our sponsors' expectations.

Biometric Resources

Ce3 provides highly qualified clinical research professionals to companies that are rapidly growing, expanding competencies or re-sizing their work force. We actively recruit, train and place personnel in functional roles vital to the clinical research process such as:

• Clinical Data Manager
• Clinical Data Programmer
• Clinical Database Designer
• Clinical Data Coder
• Statistical Programmer
• Biostatistician

Our Team

Our management team started in big pharma and learned what it takes to support clinical studies. Just as important they learned what is needed to form a collaborative work environment.


Holly Coulter

President & Chief Executive Officer

Holly has been engaged for over 30 years in pharmaceutical research. For 21 of those years she worked at Bayer Pharmaceutical Healthcare and later at Purdue Pharma LP holding domestic and international positions...

Timothy Garrelts

Vice President & Chief Operating Officer

Tim has over 20 years of experience in the biopharmaceutical industry holding positions of increasing responsibility throughout. He started in the pharmaceutical industry as a Medical Research Associate...

Deborah Church

Chief Medical Officer

Dr. Church is an infectious disease physician with 20 years of experience in the pharmaceutical industry specifically working on the creation and implementation of clinical development plans, products approvals, post-launch...

Experience

Our approach is focused on servicing Biotech and Small Pharma:
To meet the needs of this client base we provide seasoned professionals experienced in a broad set of therapeutic disciplines to address the increasing array of discovery and early clinical development targets. The maturity of our staff brings stability along with domestic and global experience. Our backgrounds, appreciation for training, and focus on quality allow Ce3 to meet virtually any client’s needs.

Our strength:
Our strength is in the crisp, responsive review and execution of clinical protocols. We quickly mobilize a team of technically competent personnel fluent in GCP/ICH guidelines to meet your project needs.

Core experience:
While our past experience covers a wide variety of therapeutic areas, we have particular expertise in Oncology, Infectious Disease, and Cardiovascular indications. Of note is our ability to manage early phase studies in these areas including complex cohort driven protocols.

-ArQule Announces Tivantinib Meets Primary Endpoint, Significantly Extending Time to Progression in Phase 2 Trial in Second-Line Hepatocellular Carcinoma
Press Release issued by ArQule on January 17, 2012.
Ce3 Inc. contributed to the conduct and execution of this study.

-FIRST IN HUMAN STUDY WITH ARQ 621, A NOVEL INHIBITOR OF Eg5: FINAL RESULTS
Presented at the 2011 ASCO Annual Meeting - Chicago,IL - 3-7 June 2011
Ce3 Inc. contributed to the conduct and execution of this study.

-Phase 1b Results of c-MET Inhibitor Tivantinib (ARQ 197) in Combination With Gemcitabine in a Cohort of Patients With Advanced Breast, Ovarian, or Uterine Tumors
Presented at the 2011 ASCO Annual Meeting - Chicago,IL - 3-7 June 2011
Ce3 Inc. contributed to the conduct and execution of this study.

Core areas

Oncology & PH 1 NHV are Ce3's core areas of expertise.

Percent of studies by therapeutic areas

ONC

45%

PH 1 - NHV

39%

Other

17%

Contact


246 Goose Lane, Suite 202| Guilford, Connecticut|06437

(203) 404-7500
info@Ce3inc.com