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Office of Clinical Trials (OCT)

Resources and Partnerships

Biomedical Research Alliance of New York (BRANY):

BRANY is an outsourcing agent for Montefiore and Einstein for some of our clinical trials portfolio. The Montefiore - Einstein IRB automatically accepts BRANY IRB determinations. Some additional services rendered by BRANY include contracting and budgeting, along with regulatory administration and study invoicing for services. BRANY is also available to provide monitoring services for investigator-initiated studies. Investigators at Montefiore and Einstein are able to use BRANY and their services conjointly or selectively. OCT staff will help you sort your way through this. For more information on BRANY please visit the BRANY website.

 

Einstein Institutional Review Board: 

The Einstein Instutional Review Board (IRB) operates under Federal regulations, State laws, and institutional policy, to review research involving human subjects and ensure the ethical and equitable treatment of those subjects.  

Please visit the Einstein IRB’s website for information on policies, educational tools, and other resources.  

  

Merge Clinical Trial Management System:

The Office of Clinical Trials (OCT) uses Merge CTMS, a clinical trials internet based management system used to track and account the work of trials that are administered.

This allows our office the ability to:

  • Record study information
  • Store and organize electronic documents
  • Schedule and track patient appointments
  • Build budgets
  • Manage financials
  • Manage Invoicing and collections
  • Manage Invoicing and collections
  • Customize reports
  • Study coordinators will use the software to help manage their trials. Minimal patient information will be used to monitor visit completions and study accruals.

Contact the Merge CTMS Administrator with any questions.

*Montefiore-Einstein is in the process of transitioning to a new clinical trial management system for all clinical research taking place at the institution.

  

Velos: 

Montefiore and Einstein are implementing Velos as an Enterprise Clinical Research Management System to streamline, integrate and manage all clinical trial and research activities. The Velos system will provide an exciting opportunity to standardize operations and management of research related activities and ultimately reduce workload by linking many disparate systems currently utilized for research management, eliminating duplicative work. The system will improve quality of data, ensure regulatory compliance, and streamline administrative and financial management of the studies, sponsors, and patients by providing comprehensive protocol management, patient recruitment, coordination and calendaring, regulatory reporting, adverse event management and reporting, quality assurance reporting, and consolidated invoicing and financial management. Velos interfaces with EPIC@Montefiore and with both IRB systems currently in use by Einstein and Montefiore investigators (Einstein/Montefiore IRB and BRANY IRB) to implement seamless workflows for all study personnel.  

In order to ensure that regulatory reporting requirements are met, utilization of the Velos system is required for all cancer-related clinical research conducted at Montefiore-Einstein as of January 2016.  The Velos system, the associated Standard Operating Procedures (SOPs) that have been developed as part of the implementation, and the planned interfaces with other systems, have been designed to meet compliance requirements while streamlining staff activities wherever possible. 

Stay tuned for updates regarding Velos go-live schedules for other departments. 

A Velos Sharepoint site has been set up to provide online training materials, video demonstrations and general information regarding requesting access to Velos. 

To access the site or fill out a User Request Form, click here.

   

Protocol Builder: 

Powered by the Biomedical Research Alliance of New York (BRANY), Protocol Builder is the first of its kind solution that makes writing investigator-initiated protocols faster and easier, and helps ensure protocols meet IRB and regulatory standards.  Protocol Builder is made available to PIs of Investigator – Initiated protocols in an effort to increase the efficiency and quality of protocol writing for the Montefiore-Einstein research community. 

Become a registered user here

 

Acuvia:

In an effort to continue our mission to improve the probability of success in Montefiore Medical Center clinical trials, the Office of Clinical Trials is implementing the use of the Acuvia e-Regulatory System, an electronic regulatory binder, for New Industry Sponsored and Investigator Initiated Clinical Trials managed by OCT and BRANY. The Acuvia e-Regulatory System offers a documentation and workflow solution that will replace the current hybrid paper system for the clinical trial regulatory compliance process, where some files are stored electronically in shared/network drives, while other file copies are kept in paper format in regulatory binders. By providing a venue where all regulatory documents are stored securely, research staff will have a streamlined and efficient system that will ensure regulatory compliance.  

Email the Acuvia Administrator with any questions or concerns.  

Upcoming Events

August 22 | 12:00 PM   

Lunch & Learn: Laboratory Safety Training 

TBD | 12:00 PM   

Lunch & Learn: TBD 

 

Contact

The Montefiore Einstein Office of Clinical Trials 

Montefiore Medical Center
111 East 210th Street
Moses Research Tower, 8th Floor, Room 8-014
718-920-2000
OCT@montefiore.org 

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