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PRECLINICAL OPERATIONAL SUPPORT
A preclinical study -irrespective
of whether it is conducted by your organization or subcontracted- is an irrevocable
building block of the dossier you will submit to regulatory authorities. Every study
engaged under Good Laboratory Practices (GLP) and the data generated will need to
be presented. It is therefore crucial to avoid ill-designed or ill-conducted studies
as such studies will provide equivocal results and stretch development timelines.
A good study starts with a first-rate quality protocol. The subsequent experimental
phase needs to be in line with this protocol. Finally, the report has to document
the exact procedures followed, the results obtained and the conclusions drawn.
By asking ADMERITOX to take care of your study, YOU will obtain:
- a study protocol outline, fully
in line with your preclinical development strategy, the relevant existing data and
the appropriate guidelines;
- for studies to be subcontracted:
- selection of the Contract Research
Organization according to your prerequisites and standards;
- review of the study protocol;
- a "meeting zero" with
the study team to exclude any misunderstanding of the contents of the study protocol;
- close monitoring of the critical
study phases to ensure quality in terms of science and GLP and to keep you informed
of the progress and the results;
- review of the study report and
tabulated summaries;
- for studies to be performed by
your organization:
- any type of support required,
e.g. coaching of the Study Director, quality control, review or scientific writing
of the study protocol and/or report;
- a scientific position paper in
case of results that need further explanation;
- recommendations for amendment
of the preclinical development plan in case of unexpected results that need further
investigation.
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