Our phase I units in
the UK, India and Germany have
Independent Ethics Committees
constituted in accordance with ICH GCP.
In the UK Veeda CR’s Independent Ethics
Committee is recognised by UKECA as a Type 1
REC for the review of phase I trials of
medicinal products in healthy volunteers
throughout the UK.
In Germany the IEC is
part of the Medical Association of Saxony,
constituted according to Saxonian law and
operates according to ICH-GCP. It is
additionally registered with the federal
health authority for approval of studies of
medical devices and studies using radiologic
substances or methods.
The IEC functioning in
Ahmedabad, India is constituted similarly to
the UK committee and provides the same level
of oversight of our Indian-based operations
however classification of such committees is
not current Indian practice.
The dates which
Ethics Committees meet are as flexible as
possible, usually once or twice a month.
Submissions to the Ethics Committee are
required 2 weeks prior to a meeting and the
committees deliver as fast a response as
possible, often the next day in the UK and
India. Such a fast response depends both on
the work of the committee and also the
quality of the protocols submitted before
the committee.
In Germany the approval
period for a single centre trial is 30 days
and the applicant is allowed to respond to
scientific objections once within 90 days.
However, through in-house review prior to
submission, we try to recognise any problems
prior to submission to the Ethics Committee
and make necessary changes in advance to
expedite the process.
Veeda Clinical Research is deeply grateful
to the effort and commitment of all our
Ethics Committees without whose co-operation
and support we would be unable to function
so effectively.