• Collaborative

  • Experience

  • Efficiency

  • Excellence

About Us


Ce3 is a Contract Research Organization (CRO) specializing in early phase clinical development services for the biotechnology industry. Ce3’s extensive experience in clinical trial management has led to success in many challenging therapeutic areas, including oncology and infectious disease as well as gene and cell therapy in oncologic and other indications. Furthermore, we have rescued projects mid-course, offering effective solutions to bring them back on track.


Our Philosophy

    With Ce3, you will always have the most experienced and qualified resources working on your project. Our Management Team will work with you to identify and define manageable expectations, and is adept at putting together solutions that are both cost effective and efficient. Since 2005, we have enjoyed and found success working collaboratively with smaller biotechnology clients, which is reflected in our high percentage of repeat business. As a company, we firmly believe that your success is our success.

Our Culture

Our company culture is a very important component of our success. Visitors to Ce3 often feel our positive energy and sense of commitment. At Ce3, we treat each other with respect, we celebrate diversity in people, and we encourage every employee to get involved. This leads to an environment of openness where everyone is a valued contributor and can feel free to express their ideas. We encourage interactions within and across project teams so that our product is valued by our customers, and the focus on communication and quality of deliverables is clear across all levels of the organization.

Our People

Ce3 employs people who are competent, purposeful and highly motivated. We approach our work with intensity, have fun with what we are doing, and enjoy each other’s company. Individual talents and contributions are respected, but collaboration and genuine team spirit are what we value most. We find success in making a difference, both at the individual and primarily at the team level.

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. We employ energy efficient lighting, infrastructure, and policies aimed at reducing waste and our reliance on paper.

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 specialize in early phase clinical development and regulatory submission services for the biotechnology industry.


Project Management

    Ce3 Project Managers are experienced team leaders that focus on providing on-time and on-budget results. Our Project Managers will develop a strong relationship with you and your team, and will work with you to clearly identify and define project objectives.

    Ce3 Project Managers:

    • Serve as a primary point of communication
    • 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

    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. We measure key variables and metrics of each study we conduct, and continually seek ways to improve the results we deliver to our sponsors. These metrics provide Sponsors and the project team with quantifiable mesaures of study progress and data to ensure delivery of services is on target.

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 Writing and Submissions

Ce3’s regulatory submissions experience ranges from INDs to NDAs. As we are built to support the biotechnology industry, we have vast experience in regulatory strategy, briefing packages, and coordinating and facilitating meetings with regulatory agencies.


Clinical Study Reports

The clinical study report (CSR) is the key end-product of every clinical trial. Ce3’s medical writing process is managed by a central point of contact for an experienced writing team (including experts in biostatistics, clinical pharmacology, medical, clinical operations) to develop a high-quality CSR within the timeline and budget.

Starting with an ICH compliant template, we follow a proven process for the planning, authoring, review and approval of the CSR and associated appendices. Specifically, we utilize a customizable worksite available online 24/7 to share source documentation and facilitate authoring/reviews that can be conducted simultaneously or in parallel. Tools such as customized style guides and QA/QC checklists allow clear, consistent and accurate writing while meeting regulatory requirements. After Sponsor approval of a CSR, Ce3 publishes an ICH granular CSR with appendices inclusive of bookmarks and internal hyperlinks.

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.


Data management

The success of a clinical trial depends in large part on clear and reliable data, efficiently acquired and maintained through advanced technology and proven processes. Our data management personnel have extensive experience with all phases of clinical trials. Our targeted approach to Data Management provides quality controlled solutions to biometric project management challenges from data cleaning to glossary coding including but not limited to:

• Data Management Plan
• Case Report Form (CRF)/eCRF Design
• EDC System Development and Implementation
• Database design and implementation
• Data validation, review, and cleaning
• Medical coding
• Management of data from third-party providers
• Data Transfers
• Data Warehousing
• Data conversion including CDISC SDTM
• eCRF Archival
• Study rescue services
• Data Visualization
• Database Integration
• Adaptive design consulting and simulation support
• Data Monitoring Committee services
• NDA-ready data listings
• CDISC-compliant datasets
• Integrated safety and efficacy summaries


Clinical Study Programming with SAS

SAS is a “de facto” standard in the industry. When performing studies with Ce3, SAS output is a standard deliverable. The data that is delivered back to your organization can be structured with SAS formats, labels, and other attributes to make the analysis, reporting, and pooling of the data as easy as possible. We have SAS programmers who are experienced in supporting clinical studies. They are familiar with working in a regulated environment are able to react to the emerging standards in the pharmaceutical industry.


Incorporating External Data

No study is complete until all of the data collected are brought together. The external data (non CRF data) needs to be incorporated with the main CRF data. Ce3 can combine the data into a single database, simplifying statistical analysis, and helping your organization to easily retrieve all of the data for regulatory submissions. Without proper planning, external data will be hard to combine with CRF data due to disparate keys. We can coordinate this effort and ensure all data points can be related to each other.

EDC

In today’s competitive development environment critical decisions need to be supported by near real-time data collected through a validated and 21 CFR Part 11 compliant Electronic Data Capture (EDC) system. Our personnel have over 20 years of EDC experience and have designed, built and implemented high quality databases in multiple platforms for hundreds of studies. We bring this experience to your project and tailor a system that suits the specific needs of your protocol, ensuring data can be rapidly collected and distributed to support findings and allow for informed decisions. We use leading technology platforms to provide our customers with efficiencies, improve productivity and data access, and reduce cycle time.

ELECTRONIC TRIAL MASTER FILE "eTMF" SERVICE

Our eTMF service and product provides an industry best practice approach to document management. This allows our clients to gain the insight required to efficiently manage their clinical trials. We supply the resources to perform the actual indexing for you. The eTMF team are experts, extensively trained and ready to relieve your internal study team from the burden of indexing in a consistent and retrievable manner. We work with our clients to collectively retain all essential documents and artifacts to support their clinical trials.

Biostatistics

Ce3’s experience with the FDA and the EMEA standards provides advanced statistical methodology to help you meet regulatory and safety requirements. Our Biostatistics services include:

• Protocol development and power calculation
• Randomization and blinding schedules
• Statistical analysis plans
• Statistical programming in SAS
• Interim analysis support

EDC

We thank you sincerely for all of the hard work you have performed in delivering a tremendous amount of data and analyses with high quality and on time! It is much appreciated!!

Our Team

Our management team has been working with Biotech companies since inception.



Holly Coulter

Chief Executive Officer

Holly is co-founder and Chief Executive Officer of Ce3 Inc. She is responsible for strategy and delivery of clinical research services. Holly has been engaged for over 30 years in pharmaceutical research. For 21 of those years she worked at...


Timothy Garrelts

Chief Operating Officer

Tim Garrelts is co-founder and Chief Operating Officer. He is responsible for establishing and managing business strategy, development, and operations.



Deborah Church

Chief Medical Officer

Dr. Church joined Ce3 in 2006 to bolster the company’s medical and regulatory expertise. She is responsible for establishing and overseeing medical management, writing, and submissions....

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. They address the increasing array of discovery and early clinical development targets.

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.

-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.

-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.

Contact


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

(203) 404-7500
info@Ce3inc.com