Updated Financial Administration of Clinical Trials Services (FACTS) Website Coming Soon and Other Announcements

Please stay tuned for a new reorganized Financial Administration of Clinical Trials Services (FACTS)  website that will provide a more comprehensive and transparent approach to navigating the contract life cycle through Meditract. Meditract, which was launched last year, offers users the ability to track the status of their agreements in real time.

Reflected in this new website is the fact that the FACTs team has grown. Their addition of new Senior Contracts Specialist allows for more efficient and expedient contract management and thus an improvement on turnaround time.

In addition, a new fee schedule for FACTS services was announced on March 3, 2017 and will be implemented starting April 1, 2017.

 

FACTS Office Launches Budget Negotiation Services for Industry Sponsored Research Studies

The Financial Administration of Clinical Trials Services (FACTS) office is pleased to announce the availability of budget negotiation services for industry sponsored research studies. With the recent addition of specialized staff, FACTS can now assist with the development and negotiation of budgets by doing a complete comprehensive review of the protocol in order to identify the best estimate of costs to conduct clinical research. The staff will work with the Principal Investigator and study team to identify all internal budget needs based on fair market value.

Please call the FACTS office at 646-605-7251 or email FACTS@mssm.edu to discuss these services.

 

MediTract Software Launch at FACTS

The Financial Administration of Clinical Trials Services (FACTS) office is getting ready to launch MediTract, a contract life cycle management software. MediTract enables researchers to know where their contracts are located in the negotiation process.

FACTS will implement this new software to facilitate quicker turnaround time in negotiation and assist their team with Metrics reporting along with full transparency of the contract process flow.

If you would like additional information about this exciting new venture, please contact Rosaria McEntee.

 

Agreement Navigator Launched

In July, the Office of Research Services launched a new tool called the “Agreement Navigator.” If you ever have had an agreement and you weren’t sure where it was supposed to go for processing and signature, (was it GCO or maybe MSIP or was it the FACTS office?), this new resource will help you. Confidentiality Agreements, Data Use Agreements, Subaward Agreements, and Grant Agreements are some of the categories you will find. Click here to open the Navigator. The Grants and Contracts Office posted a link in the Getting Started section of the GCO Application Info webpage and the Policies and Procedures section as well.

 

Industry Funded Clinical Trial Agreements and FACTS

FACTS (Financial Administration of Clinical Trials Services) was created as part of the Research Re-Engineering Program to offer investigators and research personnel centralized and comprehensive services for industry clinical trials. As of January 1st 2015, the FACTS Office has launched a new initiative in which all industry funded Clinical Trial Agreements and Confidential Disclosure Agreements will be reviewed and negotiated by the FACTS Office team instead of the GCO team. This change is being implemented to improve investigator satisfaction and the management of industry clinical trial agreements. It is geared toward making the administrative requirement for starting research more efficient. It will enable us to better serve the faculty engaged in industry clinical trials.

On the contracts negotiation side, we have added two-full time Senior Contract Specialists to the FACTS team.

Mary-Jo Wesley
Mary-Jo has over 20 years of Research Administration experience with an extensive background in negotiating and managing Clinical Trial Agreements. Prior to working at the Icahn School of Medicine, she came from Yale University as the Administrative and Outreach Lead of the Corporate and Complex Contracts Group.

Sandra Londono
Sandra Londono has 15 years of experience in the areas of transactional and contract law, risk assessment and mitigation, and project management spanning a wide range of industries and activities.  Sandra has Certificates in Healthcare Compliance and Pharmaceutical, Medical Device & Compliance Law.

Please send all industry funded clinical trial agreements and Confidential Disclosure Agreements to FACTS@mssm.edu. You can visit the FACTS website at http://icahn.mssm.edu/research/resources/office-of-clinical-research/resources-and-services/clinical-trials-budget-and-billing-operations.

Join the Ideate Yammer Group

The recently launched Ideate Yammer group is your source for timely updates on Ideate, Mount Sinai’s system for electronic submissions to regulatory compliance offices including the Program for Protection of Human Subjects (PPHS), the Radiation Safety Committee (RSC), the Institutional Biosafety Committee (IBC), the Investigational Drug Service (IDS), the Clinical Research Unit (CRU), the office of Financial Administration for Clinical Trials Services (FACTS) and the Institute for Animal Care and Use Committee (IACUC). On Yammer you will find notices about upcoming go-live events, instructional videos, tips and tricks, announcements on unplanned or unexpected system downtimes, and answers to any questions you may have about using the system.

Yammer is an enterprise social network that encourages collaboration and communication. You can engage in conversations and view what your colleagues have posted.  All groups are located on the left hand side of the screen.  If you have questions about Yammer, join the “Yammer 101” group where you can find helpful tools and tips on how to get started.  Feel free to post your Ideate questions to Yammer and join the conversation!

Visit this link to sign up for Yammer:
https://www.yammer.com/mountsinai.org/?show_signup=true

Once you are signed up for Yammer, visit this link to join the Ideate conversation:
https://www.yammer.com/mountsinai.org/#/threads/inGroup?type=in_group&feedId=4505882