ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• CAR T Study For Blockbuster Drug Granted Therapy Designation

  Discover how a pharmaceutical sponsor received support for an EDC and IRT database build and got help with data management and biostatistics.

• Elevating Rater Training For More Reliable Study Outcomes

  Well-trained raters are key to generating high-quality, consistent clinical trial data. Explore a program offering customized training tailored to the experience levels of raters.

• ICH E6(R3) Is Here: What Your Centralized Monitoring Strategy Needs

  ICH E6(R3) turns best practices into regulatory mandates. Learn how to maintain sponsor accountability and implement proportionate centralized monitoring through a unified, auditable data layer.

• RTSM: Randomization And Cohort Management, IP Inventory Management

  Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.

• Clinical Trial Startup: Insights From The Industry

  Uncover key survey findings gleaned from the perspectives of over 500 clinical researchers regarding technological trends and recommendations for enhancing the overall site experience.

• Evaluating Wearable Data Platforms For Endpoint-Driven Studies

  Endpoint‑driven studies need platforms that unify wearable data with trial systems, support derived measures, and ensure traceability so continuous data becomes reliable clinical evidence.

• Frequently Asked Questions About IRMS MAX

  Improve your information access and capabilities with the definitive gold standard of medical information systems.

• Avoid Database Go-Live Delays With The Right EDC System

  If you are looking to speed up your start-up process, selecting a reliable EDC System is key.

• Oncology Trials: Accuracy And Alleviating The Patient Screening Burden

  Flatiron Health has unveiled an innovative service designed to enhance patient screening for clinical trials by integrating structured EHR data with machine learning and human analysis.

• How eConsent Delivers Value For Sponsors

  Delve into the data substantiating experiences with electronic informed consent to better understand their positive impact on the outcomes of clinical trials.