Healthcare

WHITE PAPERS AND CASE STUDIES

• Best Practices For Sterilization Validation In Medical Device Manufacturing

  Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

• How To Recruit 236 Patients In An Osteoarthritis Study On Time During The Peak Of The Pandemic

  A leading Eastern European contract research organization completed the recruitment of 236 subjects in a Phase 3 osteoarthritis study for Handok Inc. despite hurdles caused by the COVID-19 pandemic.

• 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.

• Not Your Typical MES: The Ultimate Guide To Made With MX

  Life sciences manufacturing is evolving rapidly. Discover how digital transformation is revolutionizing production processes to enable personalized medicine and improve patient outcomes across the healthcare industry.

• 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.

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

• Forge Boosts Efficiency And Compliance During External Collaboration

  Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.

• 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.

• Blending Tradition And Technology For A Water-Resilient Future

  Discover how a desert utility is evolving its operations to safeguard Tucson’s water supply for generations to come.

• Providing Enhanced Manufacturing Data To Contracting Companies

  The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.

• From Paper To Digital Study Management In Large Patient Registries

  Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.

• 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).