ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Significance Of Quality Data In Meeting FDA Regulatory Scrutiny

  Data Science expert Rod McGlashing explains how scrutiny from the FDA spurs regulatory compliance, resulting in better data quality and the creation of optimal applications for intellectual property.

• Global Experience In Complex Oncology Trials

  Discover how this company was able to overcome complex eCOA challenges in an oncology study.

• eCOA/ePRO: Why Patients Deserve Even More Progress

  The shift from reporting on paper to reporting electronically has been happening for years, however, the transition hasn’t always been elegant. Explore how the pandemic has played a role in accelerating the shift to eCOA/ePRO.

• Shorten Trial Timelines With Better Evidence Generation

  Learn how digital data is helping the pharmaceutical industry tackle its most daunting challenge; the 12 year, $3 billion average to bring a new drug to market.

• Medical Device Clinical Trials: Key Considerations For Sponsors And CROs

  Medical device trials must align risk class, regulations, and study design. Strong oversight, data, and proactive safety planning support reliable evidence and market approval.

• Analyzing The FDA's Approach To Diversity In Clinical Trials

  Learn how utilizing diverse data resources and collaborating with stakeholders enables sponsors to foster a culture of inclusivity, meet regulatory requirements and ultimately advance medical science.

• The Value Of Tokenizing Clinical Development Data

  Most use cases of real-world data don’t require tokenization to deliver value. However, given industry challenges and the influx of information, see how ROI can be achieved from trial data tokenization.

• The FDA Just Rewrote The Rules For Clinical Trials. Here's What It Means For RTSM.

  Learn how evolving trial designs are changing RTSM requirements and driving demand for greater flexibility, traceability, and execution quality.

• 3-Week Database Builds That Withstood FDA Review

  Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.

• Timely Lab Data To Inform Outreach To Healthcare Professionals

  Learn how you can leverage a system that offers flexible data delivery formats and seamless integration into commercialization workflows while also ensuring HIPAA-compliant deidentified data for patient privacy.