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Clinical Trials Coordination Center (CTCC)

The CTCC provides full-service clinical trial management for academic, government, foundation and industry partners. We combine regulatory experience, digital data systems, and disease-specific expertise to run multi-center trials in the U.S. and worldwide. We design, run, and support clinical research studies—from inception to FDA submission. Our team helps sponsors and investigators with everything a study needs, including study start-up, data systems, monitoring, and regulatory support.

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Our Services

We provide clinical research services for small and large studies, investigator-initiated trials, and global multi-center trials. Our services include:

Study Start-up: protocol and consent writing, site selection, IRB submissions, site training, contract facilitation (sites and service providers).
Project Management: day-to-day study oversight and coordination, service provider management.
Data Management: 21 CFR Part 11–compliant clinical data systems, data sharing, CDISC standards.
Monitoring: remote, risk-based, and on-site monitoring for quality and safety.
Biostatistics & Modeling: analysis plans, statistical monitoring, and modeling.
Trial rescue & Recovery: audit readiness, remedial action plans, and study relaunch.
Decentralized Study Support: eConsent, ePRO, remote data collection, remote study visits.
Other Services: IND/IDE support and regulatory submissions.

By the Numbers

10

FDA-approved compounds

150+

studies managed across 30 years

45K+

research participants worldwide

100+

datasets and visualization tools

What Sets Us Apart

CTCC has the infrastructure to conduct worldwide, high quality, regulatory compliant multi-center clinical research, including:

50 sponsors (government, industry, private).
25+ IND submissions completed.
Largest repository of Parkinson disease and Huntington disease clinical trial data.
60+ SOPs and guidelines for audit readiness; 21 CFR Part 11–compliant systems and e-PRO capability.

Accessibility & Data Protections

We design studies with participant accessibility, data privacy, and regulatory compliance in mind:

All electronic data capture and e-PRO systems are compliant with 21 CFR Part 11.
We follow best practices for informed consent, accessibility, and participant support for remote assessments.
Data security: role-based access, encrypted storage, and audit trails for study records.

Frequently Asked Questions

Can CTCC serve as the sponsor or the CRO?

Yes — we can act as a coordinating center, provide CRO services, or support investigator-initiated trials.

Do you support decentralized trials and e-PRO?

Yes — we have e-PRO capability and experience with remote data collection.