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Clinical Trials Office

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    Clinical Trials Office
    Clinical Trials Office - Who We Are
  • Clinical Trials Office

    ​Who We Are

     

    The Clinical Trials Office provides contracting and budgeting services to our member-hospital investigators and their industry sponsors conducting Phase II -IV clinical trials. Under the auspices of the Office of the Chief Academic Officer at PHS, we offer tools and expertise in clinical trials set up and execution. The CTO manages broad array of agreements across the clinical trials spectrum, ranging from confidential disclosure agreements to multi-center coordinator contracts.  Our team is ready to assist PIs with both industry -sponsored and investigator- initiated trials.

    The growth of clinical trials research within the Partners Healthcare System has grown rapidly in recent years with investigators at MGH, BWH, McLean, Spaulding and Newton Wellesley participating.   Since our inception in August, 2015 we have experienced a 31% growth rate in trial agreements.  We are proud to have supported our colleagues during this expansion.

    Our support to the PHS community will soon include the introduction of OnCore, a state-of-the-art clinical trials management system.  We have dedicated teams for each of our three functional areas:  Agreements, Finance and CTMS which allows for close collaborations between investigators, sponsors and the Clinical Trials Office. 

    By assisting our many internationally respected physicians and scientists in the PHS community engaged in trials of novel therapies, we have been privileged to help shape the next generation of clinical research.

    For more information and personnel bios, click here.

    What We Do

    The CTO Agreements Team is available to draft, negotiate and execute a variety of clinical trial agreement types. These include:

    • Company Initiated and PI Initiated Clinical Trial Agreements
    • Support Agreements including:
      • core laboratory
      • study chairperson and steering committee agreements
      • equipment/software loan
      • free drug/device donations
    • Confidentiality Agreements
    • Data Usage Agreements
    • Contract Amendments

    Our team of Agreement Associates hold JD degrees and are members of the Massachusetts Bar Association.

    The CTO Finance Team is available to assist investigators with:

    • Budget preparation and negotiation
    • Payment Schedules
    • MCA analysis
    • Consultation
    • Potential subject population analyses utilizing the XXXX database

     

    The CTO Clinical Trial Management System team has been charged with the design and implementation of OnCore.  This state-of-the-art CTMS is expected to be launched in the Fall of 2106 and is intended to assist research teams with:

    • Protocol and Subject Lifecycle Management
    • Calendar and Schedule of Events
    • Financial Management – Sponsor Invoicing and Payment Reconciliation
    • Reporting

    Our team has been working with our PHS Epic and Research Applications colleagues on:

    • Standard integrations with EPIC
      • Demographics, subject-protocol link, billing grid
    • Integrations with Insight/eIRB