91ºÚÁÏ

91ºÚÁÏ and the sponsor collaborated to identify opportunities for improving specific processes related to electronic data capture (EDC) build for select studies. Through a comprehensive SWOT analysis of a suite of studies, 91ºÚÁÏ identified areas for study build process improvements across the entire portfolio. The outcome of this exercise was the establishment of consistent setup requirements, expedited build timeframes, a more robust migration process and clearly defined communication pathways.

Maintaining data integrity was a key focus throughout the project. 91ºÚÁÏ sought to enhance the migration process whilst also improving agility in relation to migration timelines. This emphasis on meeting strong timelines stemmed from 91ºÚÁÏ¡¯s discovery that feedback review rounds often exceeded contracted timelines, resulting in project extensions.

91ºÚÁÏ determined that the existing process, which was sponsor-specific, lacked the robustness necessary to ensure data integrity. As a result, the sponsor agreed to adopt 91ºÚÁÏ¡¯s migration process, which introduced documentation of all migration steps, associated impacts, audit trail reviews and sponsor oversight of all relevant
documentation.

To expedite the build process, the 91ºÚÁÏ team implemented a streamlined approach. By integrating dynamic programming alongside the build and focusing solely on critical data variables, 91ºÚÁÏ successfully built a COVID extension arm for a study, completed migration and went live in 11 business days. Throughout the build process, the team provided daily updates to the sponsor, outlining progress, risks and mitigations. Additionally, to showcase migration timelines, 91ºÚÁÏ engaged in
discussions with the sponsor presenting migration metrics across the portfolio. The data demonstrated that migration timelines were, on average, within ten weeks, with over 60% of studies completed in less than eight weeks (baseline assumptions with the sponsor).

To enhance collaboration, a single review meeting was established involving all stakeholders and leaders, with the aim achieving approval by the end of the session. If the objectives were not fully met, a second meeting was held within the same week.

In collaboration with the sponsor, 91ºÚÁÏ developed a standard definition for ¡°fix¡± versus ¡°change¡± and incorporated these definitions in slides for each study whenever necessary. Many changes were superficial and driven by the sponsor after electronic Case Report Form (eCRF) approval. 91ºÚÁÏ introduced a guidance document and an eCRF breakdown list; provided by the sponsor to establish clear guidelines on the source of forms ¨C whether they should be pulled from standards, sister studies or built from scratch. Agreement was reached at a governance level that work would not commence until these were received. For a holistic end-to-end review of the eCRFs, 91ºÚÁÏ presented its clinical user acceptance testing (UAT) prior to the release for sponsor testing.

Establishing a clear process around all areas of study build, 91ºÚÁÏ introduced a guidance document that was layered over standard operating procedures (SOPs). This integration resulted gains in quality and efficiency during the migration process. By shifting from sponsor-specific to 91ºÚÁÏ-specific processes, zero data integrity issues were identified in the 2.5 years following implementation of the revised process. Quality gains were evident with the introduction of the 91ºÚÁÏ clinical UAT, while timeline efficiencies were achieved through increased use of standard forms, as demonstrated by metrics.

Recognising the importance of effective communication and decision-making, 91ºÚÁÏ leadership initiated a consolidated, combined partnership meeting. This guided the team in reaching timely resolutions for any open or contradictory sponsor feedback. Clear migration timeline requirements were established from the outset and were subsequently recalibrated based on changes in patient enrolment.