Innovations brought to the Sponsor
- Establishment of a robust governance structure between the Sponsor, the technology provider and Quanticate: this led to transparency between all three companies which enhanced the understanding of the technology provider for the Sponsor needs. This transparency led to the Sponsor understanding how its in-study protocol changes resulted in implementation challenges for the technology provider. The technology provider had been very cognizant of the costs of implementing these changes to the extent they were merging multiple changes resulting in delays that were unacceptable to the Sponsor. The transparent governance driven by Quanticate led to the mutual understanding by the Sponsor and the technology provider of the need to marry timelines and budget.
- The tracking of all deliveries using an established project management (PM) system was implemented, to identify any potential issues as early as possible. Regular comparison of actual and baseline hour reports for specific tasks are run, to identify exactly where additional support should be sent, or assignment(s) revised. The PM system controls all on-going projects, enabling the project manager to recognize potential risk of staff becoming overloaded.
- Revision of the existing quality control (QC) SOP, and creation of a new SOP for peer review to improve quality. The latter is a third-party review process where the lead statistician follows risk-based methodology to check all key elements of the biostatistic deliverable. Training was provided on the updated QC process, which included a practical guide on the application of the QC SOP in real-life cases; implementation of QC dashboards giving in-depth access to comprehensive quality data at overall/portfolio/project level and equipping user in bunch of interactivity. All Quanticate programmers have a routine QC assessment which is used as one of key sources for improving and developing our staff.
- The latest concept is ‘library of templates’ which is crucial part of our overall EDC -> SDTM mapping process. It is based on very active cooperation between Data Management and Programming and the final outcome are sets of corresponding EDC modules and sections of annotated CRF.
Improved performance in quality of data and timelines
- Quanticate have built three databases for a single program within a span of 12 weeks for the Sponsor. While 12 weeks is a standard timeline for a database build, the challenge is that the build needed to be sequential since a change in one database would impact the other two. There have been numerous changes based on the Sponsor’s needs and these are being accommodated and managed in a manner that is exceptional. This can be attributed to our project management skills and our expertise in the systems which help us quickly respond to the changing circumstances.
- The Sponsor wanted information to flow from the EDC system to the Sponsor’s Clinical Trial Management System (CTMS). The two technology providers were unable to accommodate this interface in less than six months, which would negatively impact study timelines. The Sponsor requested assistance from Quanticate’s in-house technical experts, and within one day of discussing the scope, Quanticate had a proof-of-concept tool developed to transfer data between the two vendor systems. Quanticate’s speedy development was permitted through using best-of-breed Open Source components combined with our strong data experience. Once the proof-of-concept was confirmed by the project team to meet their needs, formal user requirements were documented and approved. Within one week, the solution was ready for full validation. This included the Audit Logging, Reporting, Alerting and Summarisation that Clinical Systems Validation and SDLC Best Practice mandates. Within two weeks, the system was deployed into production. The Sponsor was delighted as the solution met their requirements and was faster and more cost-effective than the offering from the two well-known large vendors.
- Monthly SDTM transfers to the Sponsor throughout the active life of the study have been provided to allow on-going Medical Monitoring of data. This process has involved bespoke programming solutions to automate the production and validation of SDTM datasets, which has resulted in reducing cost to the Sponsor whilst maintaining the high standard of QC we apply to all deliverables. The system that has been put in place also allows for ad-hoc requests for data (for example, for Data Monitoring Committee meetings) to be accommodated at relatively short notice compared to a more standard programming set-up.
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