Healthcare

WHITE PAPERS AND CASE STUDIES

• Paper Vs ePRO: Clinical Data Collection Methods

  Patient-reported outcomes (PROs) assess patients' health without clinician interpretation. Traditional paper methods often result in missing data and quality issues, while electronic solutions enhance data accuracy and completeness.

• Raise The Bar: Setting New Standards For The eCOA Industry

  A paradigm shift may be necessary to increase the adoption of Electronic Clinical Outcome Assessments (eCOA) in clinical research. Explore six pivotal areas where eCOA standards can be improved.

• Avoid Clinical Manufacturing Pitfalls With These Tech Transfer Best Practices

  Ensure a smooth transition from development to manufacturing by implementing a strategic tech transfer process. Review key practices for effective communication, collaboration, and risk mitigation.

• 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.

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• 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.

• Automated Validation And Centralized Data

  Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.

• 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.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• Choosing An R&D Data Management Platform For Novel Antibody Therapeutics

  Uncover how this collaboration ensured the implementation of a robust electronic system that streamlined R&D operations, increased data integrity, and ultimately supported the development of novel antibody-based therapeutics.

• Improving Patient Health And Safety: Medical Affairs

  A medical affairs department needed leaders with scientific and project management expertise. With no time for training or risk tolerance, a consultant was hired to align activities with development and launch plans.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.