Clinical Trials Operations and Informatics Branch (CTOIB)
About CTOIB
Dr. Michael Montello is CTEP's Clinical Trials Operations and Informatics Branch Chief.
The Clinical Trials Operations and Informatics Branch improves protocol development and conduct through system-supported efficient business practices, informatics tools, central review of clinical trials for human safety and subject protection, and process evaluation.
CTOIB administers and manages clinical trial support services for CTEP-sponsored trials, including:
- The Protocol and Information Office (PIO)
- CTEP Enterprise System (CTEP-ESYS)
- The NCI Central Institutional Review Board (CIRB)
- The Cancer Trials Support Unit (CTSU)
- Ancillary support activities for some trials (such as protocol writing, biospecimen tracking, EHR build, insurance coverage analysis, study awareness and training).
CTEP-ESYS comprises over 20 web applications, allowing NCI and extramural staff to review and manage trial information. Working in tandem with ESYS, The CTSU simplifies patient enrollment and trial participation for investigators and research staff, while the CIRB centralizes protocol review to expedite trial activation and enrollment. Together, these centralized clinical trial support systems expedite trial development, facilitate patient access, streamline trial conduct, enable integrated data collection, improve communication, and safeguard participants' health and privacy. Learn more about CTEP's resources for clinical trials on the Trial Development and Clinical Site Operations resource pages.
CTEP CTOIB Staff Directory
| Name | Role | Email Address |
|---|---|---|
| Michael Montello, Pharm.D., M.B.A. | Branch Chief | montellom@mail.nih.gov |
| Charles Choi, M.S. | Deputy Head of CTEP PIO | choich@mail.nih.gov |
| Shanda Finnigan, M.P.H., RN, CRCC | Associate Branch Chief for Informatics | finnigas@mail.nih.gov |
| Barry Goldspiel, Pharm.D. | Clinical Trials Support Specialist | barry.goldspiel@nih.gov |
| Li Jia, Ph.D. | Biomedical Informatics Project Manager | li.jia2@nih.gov |
| Martha Kruhm, M.S., RAC | Associate Branch Chief for Operations; Head, PIO | kruhmmar@mail.nih.gov |
| Andre Littlejohn | Extramural Support Specialist | littlejohna@mail.nih.gov |
| Joshua Lorenzo, M.P.H. | Co-Head, CIRB Strategy and Operations | Joshua.Lorenzo@nih.gov |
| Melissa McKay-Daily, Ph.D. | Health Science Policy Analyst | melissa.mckay-daily@nih.gov |
| Radim Moravec, Ph.D. | Program Officer for Biomedical Informatics Projects | radim.moravec@nih.gov |