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The Clinical Trials Office is the main service organization for assistance in contract negotiations and protocol development, providing necessary guidance and administrative resources through several departmental centers.

Protocol Development & Support
Contracts Group
  • Contract Analysts
Strategic Planning and Finance Group
Budgets Group
  • Budget Analysts
Spanish Translation Center
Research Pharmacy
Biostatistical Support


Protocol Development & Support Team

Our Protocol Development & Support Team fosters strong, progressive protocol development from inception to trial by uniting many years of knowledge and experience in private industry, and academic and medical settings. The team works to ensure trial success and integrity by collaborating directly with investigators on the improvement and refinement of submitted proposals.


Contracts Group

The Contracts Group is the first step towards processing an industry-sponsored clinical trial. During the first phase of contract execution, investigators contact this team about potential proposals. Once notified, teams of project officers act as the central liaison between investigators, sponsors, and coordinators.

Once a proposal has been submitted to the department, project officers negotiate the contract and the budget with the sponsor, as well as assemble all of the necessary documents required to prepare a file and process a project. When the contract is negotiated and all regulatory requirements have been met, the agreement is routed for execution. Upon execution, the agreement and all pertinent documents are forwarded to the Strategic Planning and Finance Group.

Analysts
Mission Statement
Contract Process
SOP for Confidentiality Disclosure Agreement (CDA)
SOP for Subject Injury Reimbursement Provisions
PI contract review form


Strategic Planning and Finance Group

The Strategic Planning and Finance Group functions as the center for clinical trial financial management. Strategic planning and finance offers assistance in the creation of budgets, account setup, document tracking, and reimbursement and revenue analysis. These services are fundamental to creating cost effective and sustainable research business models. By maintaining accurate and adequate service records, these invaluable resources are key to promoting efficient and compliant clinical research.

Additionally, this Group specializes in assessing the financial risk of clinical trials. Through the establishment of strategic financial goals, economic benchmarks are tested, policies are reviewed and modified, and funding opportunities are identified.


Budgets Group

The Budgets Group provides the first step towards securing a fiscally sound budget.  Its budget review promotes effective financial management. 

The Budgets Team acts as a liaison between investigators/coordinators and sponsors.  CTO Budget Project Officers work closely with investigators and coordinators to identify all expenses incurred by clinical trial activity.  Using these projections, they can then negotiate the optimum dollar amount allowed by the sponsor. 

To assist you in planning your proposal budget, you may download the budget worksheet, budget checklist, feasibility checklist, and instructions.

Analysts
Mission Statement
Budget Process


Spanish Translation Center

The Spanish Translation Center (STC) was established in 1996 with the goals of enlarging the pool of potential study participants and reaching out to the Hispanic community, traditionally under-represented in research studies. Our services are designed to remove language and cultural barriers to participation in clinical trials and to afford patients a wider range of treatment options.

We translate into Spanish any documents that must be read and/or completed by study subjects, and produce health-education brochures. Our Director is GCP-certified with many years of experience. Our team of language professionals has worked for many years in the healthcare field. This allows us to ensure that all translated documents meet IRB requirements. We have special expertise in translating consent forms, due to their importance in protecting the welfare and information needs of the subject. We are also experts in the translation of research questionnaires, giving great attention to precision in the transfer of meaning, facilitating data collection and assuring validity and comparability of results across languages. The STC is setting the standard of excellence in translation by creating quality documents that enhance the ability to provide culturally and linguistically appropriate healthcare.

Contact the STC: Spanish-Translation@ColumbiaClinicalTrials.org
Translation services
Instructions for sending documents to the STC
Mission Statement



Research Pharmacy

The Research Pharmacy was established by the Clinical Trials Office and is directed by Robert B. MacArthur, PharmD. It has served the varying needs of Columbia University Medical Center investigators and their sponsors since 1995.

Research Medication Dispensing and Manufacturing: The Research Pharmacy is equipped to manufacture, package, dispense, blind, randomize, and manage all dosage forms (tablets, capsules, liquids, suspensions, sterile solutions for injection, ointments, creams, etc.) for all routes of administration. Additionally the Research Pharmacy will handle drug ordering, inventory, accountability, and return shipments for study drug products, including controlled substances and devices. The Research Pharmacy can also assist in the development, testing (sterility, pyrogens, stability, compatibility), and manufacturing of novel sterile, and non-sterile product formulations.

Pharmacokinetic Study Design and Support: The experienced staff of the Research Pharmacy has assisted with the performance of well over 100 pharmacokinetic studies involving a wide range of therapeutic areas. They are available to assist with the design, and implementation of studies, and can also analyze pharmacokinetic data.


Biostatistical Support

The Biostatistics Consulting Service (BCS) is a clinical research consulting service, supported in part by the CUMC/NYPH Clinical Trials Office and provided free to all clinical researchers on the Columbia University Health Sciences campus. The BCS is staffed by members from the Department of Biostatistics at the Mailman School of Public Health. The BCS staff members have extensive expertise in clinical trials as well as other experimental designs. The members of the BCS can provide state-of-the-art guidance on statistical analysis and study design for all stages of research.

Investigators needing statistical advice or assistance in data analysis are typically accommodated within a few days of their request. The consultation process begins with an initial meeting to discuss the project. If the statistical needs of the project can be addressed within approximately 5 hours, the BCS will provide the statistical support for the project. If based on the meeting it is determined that longer-term support is required to, say, write a scientific paper or to produce a grant application, the project will be referred to other faculty members in the Department of Biostatistics for co-authorship or salary support (via serving as a co-investigator on the grant proposal). To make an appointment, please contact Shing Lee at sml2114@columbia.edu or (212)342-1266.

 
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