Healthcare

WHITE PAPERS AND CASE STUDIES

• Seamless Onshoring From China-Based CDMO

  Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• An Introduction To MES For Cell And Gene Therapy Manufacturers

  What are manufacturing execution systems, and why are they so crucial for cell and gene therapy manufacturing?

• Standardizing Content Management Across The Life Sciences Industry

  Explore a quality reference model that aims to foster further standardization within the life sciences industry, and discover the advantages of leveraging the standardized best practices within.

• 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.

• What 4 Things Do All eCOA Studies Need To Succeed?

  Learn what else, in addition to good technology, study teams need for eCOA studies to succeed.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Helping To Power The WHO Solidarity Trial Against COVID-19

  To overcome the unprecedented challenges of large-scale global clinical trials, adopting data capture solutions is essential for ensuring the success of critical research initiatives.

• 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.

• 2025 Trends In Patient Recruitment: From Disruption To Precision

  Explore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.

• Modular Automation: The Plug-And-Produce Opportunity For Life Sciences

  Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.

• Moving CGTx Clinical Development Forward In 2023

  Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.