About the Clinical Trials Unit

 

Our mission
How we operate
Services for JHU faculty


Our mission


The Johns Hopkins University School of Medicine Clinical Trials Unit serves as a gateway to foster the growth of clinical research within the SOM by means of the highest ethical and scientific standards in a time sensitive and cost effective manner. We strive to 1) facilitate routes of communication between Industry sponsorship and Hopkins investigators and 2) provide the infrastructure to perform the collaborative work forged from these connections. By facilitating these key relationships, the CTU aims to ensure groundbreaking, efficient clinical investigation leading to improved patient care.


How we operate

Increasingly, pharmaceutical companies, government research agencies and private foundations seek academic medical centers to test new therapies. A daunting challenge exists in identifying both specialty physicians and willing participants in the bureaucratic mazes typical of academic centers. Johns Hopkins has positioned itself at the top of this new wave in clinical research by overcoming this obstacle.

The Clinical Trials Unit, directed by a noted researcher familiar with the work of Hopkins' clinical faculty, serves as the catalyst that intertwine the sponsor and the academic researcher. Once the pharmaceutical company and investigator agree upon the study and approve the protocols, the CTU helps both parties carry out the trial, by facilitating all contract and regulatory approvals, assisting in patient recruitment and enrollment, and monitoring progress and quality assurance. We have conducted over 100 clinical trials with numbers steadily increasing. Projects are funded through the NIH, private foundations, and industry and encompass Phase II, III and IV studies. We also maintain a physician database enabling us to place research studies around the Institution, allowing us to choose from almost 300 interested clinical researchers. Our staff has participated in the development and phenomenal success of various novel therapeutics and biomedical devices for various diseases. Recently our principal investigators participated in studies evaluating transdermal delivery systems, COX-2 technology, and anti-platelet drugs.



Our Services for Johns Hopkins University faculty

Pre-Study Services

Creation and negotiation of internal and external budgets for the University with outside sponsors.
Communication with the funding agency for all initial study administration.
Contract negotiation, follow-up, and passage through the Office of Research Administration.

Regulatory Services

Draft of Internal Review Board (IRB) submission and consent forms.
Protocol tracking through the IRB.
Draft responses to IRB queries until full committee approval.
Collection of all regulatory documents and maintenance of regulatory binder.

Study Services

Full study coordination at JHU, Greenspring Station or Bayview.
Complete clinical, laboratory, and technical support including specimen preparation, processing, and shipping.
Clinical space for study visits and storage of laboratory supplies.
Regular meetings with the investigator(s), or designated person for study updates.
Monthly administration and reconciliation of financial statements.
Management of contract payments and receivables.

 

 

 

 

 

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