Maintenance / Service

WHITE PAPERS AND CASE STUDIES

• Navigate The Complexities Of CGTs With Regulatory And CMC Expertise

  Explore how strategic regulatory and CMC expertise helped guide a biopharmaceutical company’s regulatory and development strategy for a cell and gene therapy product.

• Quality: The Link Between Platform, Processes, And Patients

  Quality management in healthcare and life sciences is crucial for optimizing patient health. Learn how modern quality management systems optimize patient outcomes, enhance safety, and drive operational efficiency.

• How Vanguard Clinical Harnesses CDMS/EDC For Faster Results

  Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.

• Forget About Isolators: Switching From Manual Vial To Automated Bag Filling

  Discover how transitioning from manual vial filling to single-use bag systems can reduce contamination risk, improve accuracy, and enhance GMP compliance in biopharmaceutical manufacturing.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• How A Leading CDMO Reduced Yield Variability With Automation

  Explore the transformative journey of a leading CDMO company and how they adopted an innovative platform that enhances data analytics and drives pharmaceutical manufacturing advancements.

• Understanding Real-World Patient Characterization And Safety Outcomes Of DEXTENZA

  In this study, we can derive confirmation of DEXTENZA’s favorable safety profile across a broader surgical spectrum.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Endpoint Clinical RTSM: Getting The Job Done

  Explore how a Job-to-be-Done (JTBD)-focused RTSM approach reduces delays, optimizes costs, and accelerates trial success through predictive intelligence and streamlined global workflows.

• Operational Success By Strategic Investment

  Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

• Inline Checkweighing Of Packaged Products In Manufacturing

  Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.

• 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.