Even when studies appear to be progressing smoothly, it pays to monitor progress against expectations and to have independent affirmation of the quality of the work being done.  Close monitoring will allow early identification of issues that might compromise schedules or Quality, allowing these to be addressed and minimising their impact.  Monitoring may involve occasional visits to facilities to review raw data and laboratory procedures, or review of data summaries and reports by e-mail.  An in-depth awareness of individual CRO capabilities and practices coupled with successful study management skills places  Resolution  in an excellent position to monitor studies on your behalf.

If required, Resolution has the necessary understanding of the drug development process to supply Programme Management services to manage and monitor entire programmes on behalf of customers. 

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• Keeps programmes on track through identification and resolution of problems at an early stage

• Ensures the maintenance of consistent Quality standards throughout the programme and across different CROs

• Saves time and effort for the Sponsor

• Study monitoring/management can be extended to include other aspects of the development programme through the availability of Project Management services 

Method Validation
A properly executed method validation that is fit for purpose is pivotal to the successful delivery of any analytical commitment.  If method validation is not adequately completed and reviewed, sample analysis may be delayed or even require to be repeated with serious implications for the programme timings.  Resolution keeps abreast of the latest Regulatory expectations regarding method validation and can monitor and review Validation work on your behalf to ensure that suitable methodology is in place before samples are submitted for analysis.

Monitoring Progress
Sometimes with the best will in the world, CROs can let programmes drift from agreed schedules with the potential for late reports and knock-on effects to other studies and programmes.  This may be due to a lack of awareness of your expectations, limited resources, changing priorities, conflicting deadlines, a series of unresolved method problems or any number of other reasons.  Closely monitoring progress can help identify Projects that are starting to slip behind and allow corrective action to be taken. Resolution can monitor progress on your behalf and act to ensure that programmes stay on track.

Review of Data and Reports
Data generated in the course of a study should be reviewed on an on-going basis to verify integrity and provide an independent assessment of on-going quality of the analysis on your behalf.  Reports can be reviewed to ensure they meet your requirements regarding style, content and quality and are consistent with other parts of the programme.  If required, Resolution can help with writing reports to ensure your results are presented clearly, concisely and unambiguously.

Site Visits
Resolution is able to offer Site Visits to review progress, methodology or data, and to help resolve any problems that may have been identified.

If your organisation is planning to outsource entire development programmes, Resolution has the knowledge and experience to work with you and other expert consultants to ensure that all aspects of the drug development are properly integrated and scheduled to allow your programme to progress as quickly as possible.  All aspects of a programme can be covered, including planning, budgeting, laboratory selection, scheduling, monitoring, review and coordination of the interactions between the different groups and disciplines involved in the programme.