If a regularly used CRO has not been subject to an independent facility inspection in the last 12 months, or if a new facility is to be used for the first time, it may be useful to consider a visit to ensure that staff, facilities and procedures employed meet the required standards of experience, competence and quality.  These assessments are different from Quality Assurance audits because they include a detailed assessment of the scientific practices of the facility in addition to considering GLP compliance.  Many issues which may be of significant technical or regulatory concern to an expert may nonetheless satisfy basic GLP requirements and therefore not be immediately apparent to a QA Auditor.  Resolution recommends conducting such technical audits of all facilities used.

In addition, if a retrospective expert technical review or scientific audit of analytical data is required, for example as a result of receipt of the US FDA letter of 10 Jan 2007 concerning certain studies in support of Approved and Pending Abbreviated ANDAs, Resolution is able to meet this requirement.  Refer to Analytical Data Review for more details of capabilities in this area.   

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• Resolution has the necessary experience to assess the suitability of a facility for your programme from a GLP perspective

• Resolution has the necessary scientific expertise to conduct technical audits on the competence of a facility

• Avoids the need for your staff to travel to CROs

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 laboratory and management experience to fully assess if a CRO is capable of delivering what is required to the necessary standard within the desired timeframe through assessment of the following key aspects.

Assessing Facilities
Dr Gerry McGuire has experience of visiting Laboratories and facilities all over the world and has participated in GLP inspections involving the UK Monitoring Authorities and the FDA for many years.  He is therefore able to evaluate and assess if potential facilities have the competence, resources, commitment and Quality to meet your Project requirements.

Assessing staff training and competence
Properly trained staff are vital to success on any programme.  Resolution has the training and management experience to review and assess staff competence against your needs and the needs of your programme.

Technical Audits
In depth practical experience coupled to a sound understanding of GLP and Regulatory requirements enables Resolution to critically review and appraise all procedures, from planning and scheduling through to laboratory work and the operation of equipment, to ensure these meet the expected standards.