Data Management and FSP Services Shave Weeks Off Startup Time
The Challenge: Manual Processes Inflate Budgets and Timelines
A top 5 global dermatology company spanning more than 6,000 employees and more than 100 countries turned to Quartesian to provide clinical data management. However, the client received much more: a review of their processes to find efficiencies, reducing timelines and budget while improving data quality.
Clinical trial sponsors are under constant pressure to reduce costs while maintaining quality, timeliness, and compliance with regulatory requirements. The dermatology company’s study setup, database build process, and edit check specifications were not optimized for automation. Manual data review and ad-hoc programming led to time-consuming rework and database lock delays.
Correcting this approach would improve the company’s chances of success when bringing treatments to market — and Quartesian had the deep domain expertise in both data management and Medidata Rave to make it happen.
The Solution: Expert SAS Programming, Automation, and Process Optimization
Initially, Quartesian was contracted to provide data management services only. At the beginning of the project, however, Quartesian discovered that much of the data querying and cleaning was done by hand, creating bottlenecks and increasing the likelihood of error. Quartesian assigned its most experienced data coordinators to institute good clinical data management practices and edit check specifications.
Quartesian deployed SAS programmers to develop supplemental SAS and Excel programs for a more efficient data cleaning process, and leveraged algorithms to review large portions of the data. By providing this supplemental programming and using EDC technology to capture data discrepancies, Quartesian helped automate the previously manual process. This drastically reduced the data cleaning and lock timeframe, while also reducing errors and improving overall data quality.
The Outcome: 75% Reduction in Time to Database Lock
After evaluating the dermatology company’s processes and finding efficiencies, Quartesian delivered far more than just a clean, locked database on time and budget. By offering not only clinical data management experience but also SAS and Medidata Rave programming, Quartesian was able to improve the data cleaning process while ensuring the highest level of quality — all at the most cost effective rates in the industry.
This engagement reduced the company’s database lock from last-patient-last-visit from 3-4 weeks to one week, a 75% decrease. Standardizing database builds using Medidata reduced study startup time from eight weeks to five weeks for this project — a three-week difference.