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.

• Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation

  Growing oligonucleotide complexity is straining traditional analytical workflows. See how automated LC‑UV‑MS processing offers a scalable way to boost throughput and reduce manual effort.

• Automated Evidence Generation For Regulatory-Grade RWD

  Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.

• 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.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• Decentralized And Community-Based Solutions Driving Women's Healthcare

  Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.

• 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.

• 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.

• Novo Nordisk Harmonization Of Quality And Change Management

  See how Novo Nordisk, a global biopharmaceutical company, transitioned from a paper-based Quality Management System to an automated solution to enhance efficiency and compliance in change management.

• Navigating Regulations And Risk Management For Ophthalmic Medical Devices

  Ophthalmic medical device safety relies on regulatory compliance, rigorous risk management, and thorough testing, ensuring quality, patient safety, and effective vision care worldwide.

• Advances In Regulations For Viable Environmental Monitoring

  Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.