Healthcare

WHITE PAPERS AND CASE STUDIES

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• Navigating The Privacy Tightrope For CTIS

  Examine the challenges, potential risks, recommended best practices, and future trends related to anonymizing personal data for Clinical Trials Information System submissions.

• Streamlining Global Respiratory Trial Complexities With Robust Data Capture Strategy

  Want to see how eCOA solutions can simplify patient-reported data capture and accelerate global trials? Explore implementation strategies, lessons learned, and measurable results.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• CHO Cell Lines For Recombinant Protein Production

  Discover how new strategies in CHO cell line development are driving innovation and transforming the future of biologics manufacturing, from enhanced productivity to improved therapeutic quality.

• As Rates Of Uterine Cancer Rise, So Do Racial Disparities In Care And Outcomes

  Learn about several factors that contribute to racial disparities in uterine cancer and how targeted interventions such as increased access to healthcare, improved patient-provider communication, and cultural competency training can ensure equitable and effective healthcare for all patients.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• Creating Sustainable Data In The Laboratory

  In a laboratory setting, data is everywhere. Learn in-depth about data challenges, the importance of data lifecycle management in laboratories, and the need for data sustainability.

• Robust Models For Supporting PV And Medical Information Activity

  Learn how outsourcing local pharmacovigilance and medical information activities to an established safety organization can provide high-quality expertise and technology that meets demand.

• How Syneos Health Tackles Protocol Complexities

  Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase IIV clinical trials, particularly under a complex adaptive trial protocol.

• Streamlining Trials: How To Upgrade From Paper To EDC

  Electronic modes have been shown to improve data quality in clinical trials. Address how equivalency can be achieved when migrating PROs from paper to ePRO.

• Still Using Paper Diaries To Capture PRO Data? Read This.

  Access real-world examples of how electronic patient-reported outcome measures (PROMs) optimize data quality and reliability and improve the statistical power of trial data.