Clinical Trial Services

Conducting a clinical trial requires careful coordination, planning, and attention to regulatory, financial, and operational details. There are many specific steps that must be considered in order to start and complete a clinical trial successfully. The HSC provides a range of resources to support clinical trial processes and procedures.

Feasibility: When you are designing a clinical trial or considering participation in a clinical trial, you need to address feasibility — or whether a study can be executed successfully at UNM Health Sciences. Assessing feasibility may involve:
- Patient availability and access
  - Investigators can access UNMH electronic medical data (Cerner) through the CTSC Data Warehouse to identify a cohort of potential patients in aggregated form.
  - TriNetX (available through CTSC Informatics) can be used to run queries on the number of potential patients at UNM that could qualify for a trial. National data from other member sites is also available. Please contact the CTSC research concierge for more information and to request informatics services.
- Knowledge of the clinic/hospital setting.
- Procedures and coordination with clinical units within UNM Hospitals. For more information, please contact Leslie P Byatt, Director, Clinical Trials Operations.
Clinical and Translational Science Center (CTSC): CTSC offers many services to conduct clinical trials, including research clinic rooms, procedures (e.g., blood draw, EKG, DEXA, infusion), nutritional support (including meal preparation), full coordination, and patient recruitment services. Please contact the research concierge for more information.
Clinical Trial Office at UNM Hospital: You may need to use hospital outpatient clinics, inpatient beds, or other procedures such as X-rays, MRIs, and sleep studies. Interventional human clinical trials require a Medicare Coverage Analyses be completed by the CTO as part of the budget/contracting process. In order to learn about these services and the associated costs, visit the Clinical Trials Office website or contact Leslie P Byatt, Director, Clinical Trials Operations.
Contracts and Ancillary Documents: The Sponsored Projects Office is the primary resource for submission, review, execution, and questions regarding clinical trial contracting, NDA/CDAs, DUAs, and MTAs. For more information, contact HSC-Preaward@salud.unm.edu.
Investigational Drug Services (IDS): All investigational products need to be stored and administered by the Investigational Drug Service (IDS) pharmacy. For more information, please contact the service at investigationalpharmacy@salud.unm.edu.
Budget: Budget review and approval fall under the purview of the principal investigator. As you learn about the needed resources, the CTSC concierge and Clinical Trial Office at UNM Hospital can assist you in determining costs for services.
Human Subject Protections/IRB: For questions about your study protocol, informed consent, Single IRB, training opportunities, clinicaltrials.gov, or certificates of confidentiality, please contact the IRB On the Go Manager.

The following clinical trial services may be needed if you are designing a clinical trial as a single site or as the primary site of a multi-site study:

Human Research Education and Outreach: The Office of Research provides educational support and individual consultation with the IRB On the Go Manager on all matters related to human subjects research and IRB review procedures. Learn more here.
Biostatistics services, including statistical/data analysis plan creation, power calculation, sample size estimates, general data analysis, and assistance with manuscript writing and review. Contact the CTSC research concierge.
REDCap, a survey and database creation tool. Contact the research concierge.
Data sharing and management plan consultation: the Health Sciences Library and Informatics Center provides resources for data management; learn more here.