To lead clinical trials that push the boundaries of discovery for a healthier tomorrow.
To support the Johns Hopkins community as a trusted gateway to clinical trials through customer-centric leadership, robust infrastructure, and harmonized processes.
Message from the Senior Associate Dean for Clinical Trials and Capital Region Research
Welcome to the Johns Hopkins Office of Clinical Trials! I'm Dr. Mark Sulkowski, Professor of Medicine in the Division of Infectious Diseases, Department of Medicine, and the Senior Associate Dean for Clinical Trials and Capital Region Research in the School of Medicine. I'm thrilled to partner with Dr. Gail Daumit, the Vice Dean for Clinical Investigation, and Dr. Daniel Ford, director of the John Hopkins Institute for Clinical and Translational Medicine (ICTR) to transform the Johns Hopkins Medicine clinical trials ecosystem.
As an academic clinical investigator, I've partnered with colleagues at Johns Hopkins, other academic institutions, government agencies, and industry to lead clinical trials that revolutionized the treatment of people with chronic hepatitis C infection. These partnerships made a remarkable difference for people with hepatitis C by delivering curative treatment with minimal side effects. Clinical trials are central to ensuring that we improve the health of our patients and our population by advancing innovative therapies and strategies for the diagnosis prevention and treatment of disease.
The Johns Hopkins Office of Clinical Trials is a service organization committed to enabling John Hopkins clinical investigators and our patients to improve human health by pushing the boundaries of discovery through clinical trials. We're here to help and look forward to partnering with you!
We are transitioning from our current clinical research management system (CRMS) to OnCore, a clinical trial management software system used to manage clinical trials. OnCore will serve as a single, centralized, web-based enterprise resource to support clinical research studies conducted at JHMI. The new Clinical Trial Management System will vastly improve our functionality for clinical research management, particularly post-award invoicing and financials.
For additional information, newsletters, and training visit: JHM Research Hub
Medasource is a Clinical Research consulting and support firm partnering with over 150 leading research institutions, health systems, academic medical centers, and pharmaceutical companies. Their flexible & shared sourcing model provides solutions specific to team/department needs. Medasource provides short-term and long-term support in the following areas:
- Research administration (pre and post award)
- Clinical Trial Project Management
- Clinical Trial Contracts and Finance
- Regulatory compliance
- Medical and Scientific writing
- Data management
If you are interested to utilize Medasource for staffing or other purposes please contact the OCT at [email protected]
The Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program provides guidance to clinical investigators, sponsors, and sponsor-investigators regarding the process to secure institutional approval to serve in the role of sponsor-investigator and submit an application for an IND or IDE to the FDA in accordance with the institutional policy on Investigator-held INDs/IDEs.
For more information or questions: [email protected]
On May 20th, the office of Clinical Trials celebrated Clinical Trials Day 2023 at each of our hospitals. The event was a tremendous success, drawing a substantial crowd of staff, faculty, and patients who enthusiastically visited our exhibits.
During the event, we took the opportunity to honor and celebrate the invaluable contributions of clinical research professionals. We also expressed our heartfelt gratitude to the patients who participated in these trials, recognizing their vital role in advancing medical knowledge and improving healthcare.
Throughout the exhibit, our dedicated team of experts enthusiastically addressed numerous inquiries from both staff and visitors, providing valuable insights and information about clinical trials. The interactive nature of the event created an engaging atmosphere, and attendees had a great time exploring the exhibits and participating in discussions.
One of the highlights of the event was the giveaways, especially the water bottles which generated a lot of excitement among the attendees. Additionally, taking pictures with the “I AM” signs proved to be a popular attraction, with people enjoying capturing memorable moments during the celebration.
Given the overwhelming positive response, we are thrilled to announce that we plan to make this event an annual tradition. We eagerly look forward to organizing another Clinical Trials Day next year.
Thank you once again to everyone who participated in making this event a resounding success. Together, we continue to drive innovation and improve healthcare outcomes through clinical research.
Enjoy the pictures!
On December 8 and 9, 2022, the Office of Clinical Trials (OCT) hosted its first retreat at the Johns Hopkins Carey Business School with expert collaborators Julie Cade-Rey, Faculty, Johns Hopkins Bloomberg School of Public Health and Johns Hopkins Carey Business School and Amy Murphy, Assistant Director of Organization Development and Effectiveness.
Senior Associate Dean for Clinical Trials and Capital Region Research
Marian De Backer
Director, Office of Clinical Trials
Director, Clinical Research Program Operations and Capital Region Research (CAPRES)
Executive Director, Clinical Research Contracting
Director, Clinical Research Support Service
Associate Director, Clinical Research Billing Compliance (CRBC)
Director, Johns Hopkins University IND/IDE Program
Director, Clinical Research Revenue Cycle