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ClinicalClinical

C-TASC can provide comprehensive support for conducting all phases of clinical studies including administrative support, protocol writing and management, manual of operations writing and management, training and certification, case report form development, complete data management, statistical support, data monitoring and reporting, manuscript and abstract preparation, site monitoring and core laboratory support.

Submission (includes OTC. Medical Devices)Submission (includes OTC. Medical Devices)

C-TASC is an experienced CRO for the NHLBI in the BABY HUG study.  As such, C-TASC has been responsible for submitting all of the required materials for FDA review of this clinical trial. C-TASC knowledge about the internal review system at the FDA combined with the  recent hire of a regulatory expert in FDA submissions ensures that C-TASC staff will be more than able to prepare all of the required regulatory submissions to the FDA.

Phase I StudiesPhase I Studies

Phase II StudiesPhase II Studies

Phase III StudiesPhase III Studies

DSMB Meeting SupportDSMB Meeting Support

Regulatory SupportRegulatory Support

Post SubmissionPost Submission

C-TASC is equipped to assist in the conduct of post-submission studies intended to derive additional information about a drug or device’s risks, benefits and optimal use, after it has been approved for use by the FDA.

Phase IV StudiesPhase IV Studies

SERVICES
Pre-Clinical
Clinical
Epidemiological
Publications
Other Services

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