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OpenClinica for FDA-regulated trials

Hi,
We are a research center within the US Department of Veterans Affairs (VA) and would like to get in touch with users that have used OpenClinica for FDA-regulated trials. We are currently evaluating OpenClinica for potential adoption within the VA, but would like to know how others have used it under similar requirements and regulations.
Thanks in advance,
Frank Meng, Ph.D.
VA Boston Healthcare System, MAVERIC
[email protected]

Comments

  • Dear Frank,

    OpenClinica has been used for FDA-regulated trials for a while. A search throws up a variety of things:
    http://www.google.com/search?q=openclinica+fda

    Including Ben from OpenClinica saying (in Aug 2011):
    “For the past six years OpenClinica has been used in FDA-regulated clinical trials,” said director of business development Ben Baumann.
    http://www.pharmatimes.com/article/11-08-30/OpenClinica-Athena_alliance_takes_CT_software_to_China.aspx

    Is there a particular type of trial you are thinking about running?

    Yours,

    Michael
    Sent: 31 January 2012 12:50
    To: [email protected]
    Subject: [Users] OpenClinica for FDA-regulated trials

    Hi,

    We are a research center within the US Department of Veterans Affairs (VA) and would like to get in touch with users that have used OpenClinica for FDA-regulated trials. We are currently evaluating OpenClinica for potential adoption within the VA, but would like to know how others have used it under similar requirements and regulations.

    Thanks in advance,

    Frank Meng, Ph.D.
    VA Boston Healthcare System, MAVERIC
    [email protected]
    The University of Dundee is a registered Scottish Charity, No: SC015096
  • LizRLizR Posts: 60
    Hi Frank,
    We're using it for Phase I and II clinical trials over here at TRACON. I don't know how your needs would differ from life in a pharma company, but our trials are FDA regulated and comply with GCP. You can feel free to contact me off-list if you like.
    Kind regards,
    Liz
    Liz Robertson
    Director of Data Management
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
This discussion has been closed.