Healthcare

WHITE PAPERS AND CASE STUDIES

• What FDA CRLs Reveal About Method Validation

  FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

• Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies

  Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.

• Finding An RTSM Software To Keep Up With A Small Biotech

  Stop letting rigid RTSM builds stall your oncology trials. Learn how agile configuration and right-sized documentation keep Phase I studies on track during frequent protocol amendments.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• Raise The Bar: Setting New Standards For The eCOA Industry

  A paradigm shift may be necessary to increase the adoption of Electronic Clinical Outcome Assessments (eCOA) in clinical research. Explore six pivotal areas where eCOA standards can be improved.

• What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research?

  Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.

• 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.

• Paper Vs ePRO: Clinical Data Collection Methods

  Patient-reported outcomes (PROs) assess patients' health without clinician interpretation. Traditional paper methods often result in missing data and quality issues, while electronic solutions enhance data accuracy and completeness.

• Working Smarter: Empowering Water Operators With Integrated Data

  As water utilities face the challenges of sustainability, efficiency, and service quality, digital technology has become a necessity. The right tech can help deliver reliable service, optimize systems, and meet sustainability goals, but integrating the data streams these solutions generate can offer even greater gains – allowing utilities to move faster and achieve more powerful outcomes.

• Understanding And Implementing USP <665> For Single-Use Systems

  New expectations for single-use systems require structured risk assessment and extractables testing. As compliance deadlines near, practical guidance aligns science, knowledge, regulatory readiness.

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• Overcoming Participant Compliance Challenges In A Medical Device Study

  Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.