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Trials facilitation

The mission of the Clinical Trials Office is to facilitate and enhance the timely execution of quality clinical studies at CUMC by providing support services to investigators in connection with federal and foundation grants, industry-supported clinical trials, as well as internally developed investigator-initiated trials.

The CTO supports the effective, efficient and reliable evaluation of new pharmaceuticals and medical devices in collaboration with sponsored organizations. The CTO is a one-stop, full- service resource for organizations committed to the highest quality clinical studies. Services include:

-Expediting study placement through trial facilitation
-Identifying outstanding clinical investigators and researchers with unique skills, training, and resources
-Facilitating all IRB and regulatory services, including consent development, document collection and IRB submission along with general study support to ensure compliance throughout the duration of the clinical trial
-Facilitating the preparation and submission of investigator-initiated investigational new drug application (IND) or investigational device exemption (IDE)
-Comprehensive study budget preparation and contract negotiation through our Budget and Contract groups
-Consultation as needed between our key opinion leaders and study sponsors
-Assistance with creating a comprehensive approach to maximizing recruitment efforts through centralized database access
-Providing the full range of services from site initiation to study close-out, and
-Provide trials information and referral services for physicians and patients.

Please visit www.clinicaltrials.gov for more information.

In addition, the Columbia University Clinical Research Center (CRC) is an on-campus comprehensive support center for inpatient and outpatient adult research. The CRC provides inpatient and outpatient research space, research nursing, bionutrition and data management assistance, biostatistical consultation, research pharmacy, and core laboratory services.

Please visit irvinginstitute.columbia.edu for more information.

Columbia University, as one of the leading medical research institutions in the United States, takes pride in having formed major corporate collaborations that respect the needs of companies and maintain the principles and autonomy of the academic process and culture.

Please visit cumc.columbia.edu for more information.

The CTO web site contains an on-line submission tool as well as a portal for investigators to view the progress of pre-award negotiations, post award receipts, and other useful links.

Please visit www.columbiaclinicaltrials.org for more information.

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