\nGraham Craig (GSK) explains the impact of smart automation on time to database lock\n<\/p>\n<\/p>\n
\n³Ô¹Ï±¬ÁÏ Electronic Data Capture (EDC) and ³Ô¹Ï±¬ÁÏ DQS have advanced GSK\u2019s connected environment, enabling it to introduce smart automation at scale. Here are four ways it has helped accelerate clinical data management \u2014 and reduce average study timelines.\n<\/p>\n
\nBefore introducing ³Ô¹Ï±¬ÁÏ DQS, GSK\u2019s data managers used 40+ systems to manage trial data and were forced to aggregate data manually from disparate sources, using spreadsheets.\n<\/p>\n
\nWith DQS, GSK is automating data ingestion and harmonization across all relevant sources (e.g., eCRF, external study data) into a single environment. Frequent updates make it easier to export the latest data to stakeholders in other functions (e.g., clinical science, medical writing).\n<\/p>\n
\nPreviously, understanding data cleaning progress was a challenge while SAS checks and listings complicated the overall data picture.\n<\/p>\n
\nSince consolidating its cleaning activities to one tool, data managers use a single control center to manage discrepancies and have better cleaning oversight. They can also use a \u2018snapshot\u2019 of patient data to signal where they are in their data-cleaning journey to downstream teams.\n<\/p>\n
\nThe old approach was to freeze patient data form by form, which diverted specialized resources from value-added tasks.\n<\/p>\n
\nBy using DQS functionality, data managers can quickly demonstrate that study data hasn\u2019t changed, reducing the need for study data tabulation model (SDTM) reviews. Additionally, medical writing has automated the \u2018lift and shift\u2019 of data, accelerating clinical study report generation.\n<\/p>\n
\nBefore implementing ³Ô¹Ï±¬ÁÏ EDC, reports were generated at the subject level, so identifying data changes was laborious. With ³Ô¹Ï±¬ÁÏ EDC, data managers access the latest data from the day of receipt and run study-level reports, enabling them to identify data changes at the subject, site, or country levels.\n<\/p>\n
\nData change extract reports pinpoint critical data within the eCRF. This supports GSK in fulfilling its risk-based responsibilities for audit trail review, adhering to the latest guidance from the EMA.\n<\/p>\n
\nA connected environment ensures study data flows to the right stakeholders. By enabling these smart automation use cases and accelerating clinical data management, GSK has almost halved average study timelines, from a median of eight weeks to just 4.4. Its future target is two weeks to database lock.\n<\/p>\n