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WHITE PAPERS AND CASE STUDIES

• Patient Perspectives On eConsent

  Explore how eConsent enables participants to engage meaningfully with consent documentation, addressing information dissemination, explanation, and recall challenges.

• 4 Steps To Understanding The Quality Journey

  Explore a four-step framework for organizations to enhance quality management, emphasizing its importance in driving business success, customer satisfaction, and competitive advantage.

• Disclosure Management System: Build Or Buy?

  Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

• Ensuring Reliability And Patient Safety With XiltriX

  Protect the integrity of your therapies and ensure patient safety by investing in reliable, real-time environmental monitoring systems that proactively address operational vulnerabilities.

• Modernizing Operational Maintenance At Treatment Plants

  In 2017, the Harford County Division of Water and Sewer began looking for a modern work management solution to help automate preventive maintenance, coordinate work activities between groups, manage material inventories, and capture important data.

• Patient Insights Informed Consent Engagement

  By incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.

• Combining Digital Platforms And QbD Principles

  How can data and digitalization further improve pharmaceutical development and the continuous, quick, and efficient delivery of products?

• Leveraging Machine-Learning For SDTM Mapping

  The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) represents trial data in a standardized format for review, but could its preparation be automated?

• Regulatory Publishing Expertise Across The Entire Development Journey

  Learn how with expert support, three separate sponsors were able to issue flawless IND, MAA, and NDA submissions to the FDA and EMA, expediting the process of bringing their product to market.

• Today And Tomorrow: WaysTo Accelerate Decentralized And Digital Trials

  Learn about the need for investment in modern technology platforms to successfully handle the influx of new data streams available in research today, as well as those coming in the future.

• Navigating The Privacy Tightrope For CTIS

  Examine the challenges, potential risks, recommended best practices, and future trends related to anonymizing personal data for Clinical Trials Information System submissions.

• 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.