Healthcare

WHITE PAPERS AND CASE STUDIES

• 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.

• Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection

  Explore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• Operational Success By Strategic Investment

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

• 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.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• 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.

• Hot Springs Combats Aging Infrastructure Challenges With Xylem Digital Solutions

  The City of Hot Springs, Arkansas knows the challenges of dealing with aging infrastructure well. The city’s 143-year-old system covers 923 miles of water mains in rocky terrain, making it difficult to detect leaks. That is why the utility’s water department decided to act. 

• Maintaining Quality And Regulatory Compliance To Support Rapid Global Growth

  Discover how Huvepharma, a global pharmaceutical company, implemented software to standardize quality management processes across its manufacturing sites, enhancing compliance and efficiency.

• Democratize Batch Data Management For AAV Gene Therapies

  Explore a biotechnology company's process of choosing a data management solution that offered centralized batch data management, allowing the company to streamline its CMO data delivery process.

• Preparing The Next Generation Of Clinical Research Professionals

  Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.