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Data management plays a formative role in driving clinical development and supporting sponsors' success. Veristat’s flexible global data management approaches enable even the most complex clinical data challenges to be overcome quickly and successfully, a win for sponsors and patients alike.
Terilynn Koster, Senior Director, Global Data Management at Veristat, shares her thoughts on how a quality data management program supports the development of safe and effective new therapies.
👉 Industry-leading Data Management Capabilities
Evolving operational and regulatory complexities create a unique set of challenges that impact how clinical data is managed and governed to align with the clinical trial’s objectives. Veristat’s end-to-end capabilities provide our sponsors with a trusted resource that brings the right people, processes, and technology together to glean the most value from clinical data and move trials forward. The design of the clinical trial database plays an important role at the start, involving such factors as identifying the types of data that will be collected (e.g., demographic information, medical history, and clinical laboratory values) and the format in which the data will be recorded.
The database design and data management process are highly dependent on the selected electronic data capture (EDC) system, which is used for clinical trial data capture and entry at the study site. EDC systems streamline data collection, helping to reduce time and minimize the risk of errors in data entry.
Listen as Terilynn describes the key principles she replies on for effective data management, and the importance of choosing the proper EDC system.
👉 Traversing Data Management Challenges
When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), timelines can be negatively impacted.
At Veristat, we routinely rely on strategic data quality control measures to monitor the data collection process and ensure there are no surprises to achieving our milestones. We conduct regular checks to ensure adherence to the protocol and data collection procedures; we implement site visits to confirm protocol compliance, and we institute validation checks via the EDC system. If data discrepancies or inconsistencies are identified, we work to rectify them immediately as discrepancy management is vital to meeting timelines and satisfying regulatory requirements.
Listen as Terilynn shares how she and her team overcame a recent data management challenge for a sponsor.
👉 Working as Partners to Ensure Success
What makes for a positive sponsor experience? At Veristat, we believe it is based on our ability to accomplish more, more effectively and with less worry for sponsors. To alleviate the challenges associated with clinical trial data management, we focus on developing strategies that support the study protocol, choosing the right EDC system to meet study objectives, establishing fit-for-purpose quality controls, identifying potential risk factors early on, resolving discrepancies quickly, and ensuring data integrity from study start-up to database lock.
A partnership with Veristat means that our highly skilled data management and statistical experts seamlessly complement a sponsor’s teams, processes, and environments. Our teams are passionate and committed to guiding you through the clinical trial and regulatory submission process. We are ready to help you successfully bring your therapies to market.
Listen as Terilynn describes the best part of her day.
Want to speak to Terilynn to discuss your data management challenges and learn how Veristat might help?
