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PRECLINICAL STUDIES
A preclinical study - irrespective of whether it is conducted by the clients' organization
or subcontracted - is an irrevocable building block of the dossier that will be submitted
to regulatory authorities. Every study engaged under Good Laboratory Practices (GLP)
and the generated data 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 a study, YOU as the client may
expect:
- a study protocol outline in line
with the 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
- for studies to be performed by
your own 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
- recommendations for amendment
of the development plan in case of unexpected results that need further investigation
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