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Esophageal perforations manifest in various clinical forms, influenced by factors such as the perforation's cause and location (cervical, intrathoracic, or intra-abdominal), the extent of contamination, and potential injury to adjacent mediastinal structures. The timing between the perforation occurrence and treatment initiation also affects the clinical presentation.
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A Knowledge Management Framework and Approach for Clinical Development.

Kathy A Salzano1, Christa A Maurer2, Jean M Wyvratt3

  • 11 Global Clinical Trial Operations: Quality & Continuous Improvement, Merck & Co Inc, Rahway, NJ, USA.

Therapeutic Innovation & Regulatory Science
|September 21, 2018
PubMed
Summary

Implementing a clinical knowledge management (CKM) framework improves knowledge sharing and retention in clinical development. This structured approach enhances decision-making, quality, and speeds up the delivery of new products to patients.

Keywords:
KMTransCelerateclinical developmentclinical qualityknowledge management

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Area of Science:

  • Clinical Development
  • Knowledge Management Systems

Background:

  • Knowledge management (KM) concepts are established but underutilized in clinical development.
  • Effective KM is crucial for organizational performance, ensuring timely information access.

Purpose of the Study:

  • To outline a clinical knowledge management (CKM) framework for clinical development organizations.
  • To highlight the benefits and components of implementing a CKM framework.

Main Methods:

  • The paper provides a high-level overview of key CKM framework elements.
  • It suggests flexible approaches for knowledge gathering, sharing, application, and retention.

Main Results:

  • A structured KM strategy can lead to more informed decision-making.
  • Enhanced quality, productivity, and faster product delivery to patients are potential outcomes.

Conclusions:

  • Adopting a CKM framework is essential for optimizing clinical development processes.
  • Strategic knowledge management supports innovation and patient-centric outcomes.