Membership Directory

CE3, Inc.

Category: Contract Research & Manufacturing
Phone: (203) 252-7594
Fax: (203) 646-9919
Website: http://www.ce3inc.com
Location: Guilford, CT

Ce3 Inc. (Contract Research at the Highest Level)

CE3 is a contract research organization specializing in Phase 1-4 clinical trials for biotechnology and small pharmaceutical companies.

CE3 stands for Collaborative, Experience, Efficiency & Excellence which are qualities that represent our core values and serve as the foundation for all that we do.

Biopharma clients benefit from our flexibility, process efficiency, low overhead, and value pricing through our collaborative relationships with state-of-the-art niche providers; a competitive edge that amplifies value in this highly regulated environment.

Project Management:
With an average of ten years of experience and well documented track records, CE3 project managers bring start-to-finish resource planning and site management skills to your project. From site selection to study close out, they know how to develop and execute plans consistent with your goals.

Site Management and Monitoring:
Whether in outpatient or inpatient settings, our site management and regionally located field monitoring personnel forge collaborative relationships with site personnel, investigators and vendors to achieve study milestones. CE3 monitors utilize EDC tools remotely to identify trends and address data issues upfront, while maximizing their time on site to ensure audit readiness.

Biometric Services:
CE3 provides a full range of Clinical Biometric services to complement the clinical trial management services, including: EDC system development and implementation, eCRF and
CRF development, glossary coding, multi-data management, transfer and integration, SAS programming, data entry, statistical analysis, submission support for CDISC – SDTM / ADaM
Creation, data warehousing and more.

Technology and Tools:
CE3 has invested in a technology platform that delivers accountability to our clients and access to reporting and document repository services they may not otherwise have at their disposal.

Electronic Trial Master File (eTMF):
Our fully validated electronic Trail Master File provides remote accessibility and sophisticated workflow management tools. Its utility and flexibility during start up, auditing, and close out streamlines all stages of the documentation process and final file transfer, simplifying the closing TMF reconciliation with the client.

CTMS:
Our fully validated Clinical Trail Management System provides the project team a backbone for
all trial related tracking and reporting that complements the TMF. Supported and maintained by
our Clinical Trial Assistants, it allows project teams to have full access to all documents, team contacts,
enrollment projections and team communications.

SOPs:
All Operations are conducted under strict adherence to our ICH/GCP compliant SOPs as required for each project. Our SOPs cover all aspects of our operation and are flexible for partnering with clients in need of SOPs for specific deliverables.

Quality Auditing:
We operate under an annual Clinical Quality Plan (CQP) designed to ensure internal adherence to our SOPs for continuous improvement and performance feedback. Our Manager of Quality Compliance and Control is certified as a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP) overseeing our CQP and site audits as an essential component in our delivery of efficiency and excellence.

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