There has recently been a number of high profile cases where analytical studies were completed, found to be compliant with GLP and reported, but 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 for such issues, Resolution recommends including an assessment of a CRO's technical competence and scientific practices before any studies are initiated (see Facility Inspections & Technical Audits) and/or conducting some degree of study monitoring (see Study Monitoring & Programme Management Services ) to allow the earliest possible 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.

 

Resolution 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.

 

This service has been of particular interest to companies receiving one of the warning letters from the US FDA in January 2007, (see http://www.fda.gov/cder/news/pharmaco_studies/default.htm).  Resolution  has the experience to satisfy the FDA's option for an independent expert audit.

   

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• Resolution has the necessary experience to assess the quality of the work from a GLP standpoint

• Resolution has the expertise to critically appraise the technical and scientific conduct of the study 

• Resolution will ensure that the review is conducted against the background of the latest Regulatory expectations appropriate to the study

Resolution can conduct a remote review of the report, and the reported methodology and results, but a thorough review requires in site access to all raw data.  Resolution is based close to Edinburgh International Airport, Scotland, therefore CROs throughout the UK and Europe are within immediate reach, and there is ready access to those organisations in North America, Japan and other destinations.  Resolution has the necessary technical expertise and GLP experience to fully assess if the conduct and reported results of a study are beyond reproach or to identify any areas of concern.  Such an assessment will include, but not be limited to, a review of the following key aspects:

On conclusion of the review, Resolution will prepare a report detailing all findings in full and including a summary of these.  Any areas of concern will be highlighted with comment on the impact of these on the overall quality of the study and, if appropriate, recommended corrective actions.