recently been a number of high profile cases where
analytical studies were completed, found to be
were later found to be deficient regarding Best Practices from a scientific, technical viewpoint. Such issues could happen on any study which is not
monitored and if they come to light at a later date, there may be no option but to perform a costly repeat of the entire study.
To avoid the potential
recommends including an assessment of a CRO's
technical competence and scientific
practices before any studies are initiated
(see Facility Inspections &
and/or conducting some degree of
study monitoring (see
Study Monitoring &
Programme Management Services
) to allow the
detection of issues that may be of Regulatory concern. If neither of these options has been adopted, then a detailed review of the analytical data as soon
as possible after the conclusion of the study will highlight any problem areas and allow any remedial action required to be taken to limit costs.
has conducted many such
audits of analytical data, including both recent and older data. Acceptable study data can be certified as compliant with sound scientific practices and regulatory
expectations at the time of the study, and any issues identified will be detailed and recommendations on the best corrective action will be provided.
notify your interest in this service and have
someone contact you, please complete the form at the
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