Premier Research’s Parallel Processing Approach (PPA) provides inherent efficiencies by leveraging the value of simultaneously performing data management, statistics, and medical writing activities. The PPA successfully implements cost-effective high quality, rapid execution of biometrics study tasks. We have tested, refined, and perfected this approach over a fourteen-year period, successfully delivering more than 300 projects. Utilizing PPA, each team initiates and processes its part of the project 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 and report and analysis formats have been completed and approved. The clinical study report can then be rapidly generated soon after database lock. By implementing PPA, time can be afforded to extensive 'end-to-end' quality control procedures where all data and results of the study are examined.