Healthcare

WHITE PAPERS AND CASE STUDIES

• 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.

• 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.

• Agentic AI And How It's Impacting Clinical Trial Research

  Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.

• EHR-To-EDC Success In A Complex, Adaptive Platform Trial

  I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.

• Inside A Collaboration To Design Cutting Edge Modular Cleanrooms

  Learn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.

• 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.

• Advanced Methodology Of PLGA-Based Parenteral Formulations

  To enable the development of optimized PLGA-based sustained release formulations, this paper offers essential insights into the polymer’s properties, fabrication techniques, and drug release mechanisms.

• 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.

• Expert Consulting And MRCT Strategy Rescues Oncology Program

  Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.

• Essential Strategies For Effective Viral Clearance Studies In Biologics Manufacturing

  Strengthen your viral safety strategy by applying science- and risk-based approaches to viral clearance planning, ensuring robust data, regulatory compliance, and patient protection.

• 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.

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.