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create new study - study phase

Hi, Paul and Tom ,
As our firm mostly work with medical devices and not with drugs the study
phases in the new study form are not relevant. It will be useful if you can
add different phases for medical devices (e.g. feasibility study, pivotal
study etc..)
Best regards,
Shmulik Adler
Clinical Trials manager.
****************************************
A. Stein - Regulatory Affairs Consulting
Beit Hapaamon (Suite 102)
20 HaTaas Str. (P.O.B. 124)
Kfar Saba 44425 ISRAEL
Tel: +972-9-7670002
Fax: +972-9-7668534
E-mail: [email protected]
*****************************************
This message and any included attachments are from A. Stein - Regulatory
Affairs Consulting and are intended only for the addressee(s). The
information contained herein may include trade secrets or privileged or
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Comments

  • Hi Shmulik,

    Thank you for your feedback on the phases of a study for medical devices. If you could provide a list of the particular phases for a medical device study, we can look to see if we can integrate those options in the creation of a new study in OpenClinica for 2.5.

    If we can not integrate the options into 2.5, we can look to provide them as an update in the first maintenance release after 2.5

    Thanks,
    Paul
    Sent: Tuesday, August 12, 2008 10:50 AM
    To: [email protected]
    Subject: [Users] create new study - study phase

    Hi, Paul and Tom ,
    As our firm mostly work with medical devices and not with drugs the study phases in the new study form are not relevant. It will be useful if you can add different phases for medical devices (e.g. feasibility study, pivotal study etc..)
    Best regards,
    Shmulik Adler
    Clinical Trials manager.
    ****************************************
    A. Stein - Regulatory Affairs Consulting
    Beit Hapaamon (Suite 102)
    20 HaTaas Str. (P.O.B. 124)
    Kfar Saba 44425 ISRAEL
    Tel: +972-9-7670002
    Fax: +972-9-7668534
    E-mail: [email protected]
    *****************************************
    This message and any included attachments are from A. Stein - Regulatory Affairs Consulting and are intended only for the addressee(s). The information contained herein may include trade secrets or privileged or otherwise confidential information. Unauthorized review, forwarding, printing,copying, distributing, or using such information is strictly prohibited and may be unlawful. If you received this message in error, or have reason to believe you are not authorized to receive it, please promptly delete this message and notify the sender by e-mail.
  • Sent from my Verizon Wireless BlackBerry
    -----Original Message-----
    From: "Paul Galvin"
    Date: Tue, 12 Aug 2008 15:54:10
    To:
    Subject: RE: [Users] create new study - study phase
This discussion has been closed.