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Premier Research utilizes the Parallel Processing Approach™ (PPA). PPA has been established in-house for a number of years and successfully implements cost-effective, high quality, rapid execution of biometrics study tasks. We have tested, refined, and perfected this approach over a eleven-year period, successfully delivering more than 250 projects. Using PPA, each team initiates processes as quickly as possible to drive projects to early completion. The timelines and deliverables are managed by a dedicated Biometrics Project Manager (BPM). The BPM works with the department leads to ensure all the critical processes and procedures for data management, statistics and medical writing are conducted simultaneously.
As soon as the study protocol and CRFs are finalized, the data management group begins database design and data entry screens, the statistical group begins the statistical analysis plan (SAP) and identification of feasibility checks, and the medical writing group begins the shell report. The writers lay out the format of the report, including all tables, figures and listings defined in the SAP, per FDA and ICH guidelines. As data arrives, it is cleaned and entered. Edit checks are run against new data and these subsets of blinded data are used to test and validate the statistical analysis programs.
In short, all the critical processes and procedures are conducted simultaneously so that by the time the final CRF is entered and validated, all the SAS programming, the analysis and report formats have been completed and approved. The clinical study report can then be rapidly generated soon after database lock, including an extensive 'end-to-end' review procedure where all data and results of the study are quality controlled. Because extensive 'pre-reviews' have already been performed and changes in style, format and content incorporated, the final review is extremely efficient and ensures a high quality product.
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