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Tools & Downloads
DIA Communities have developed a number of tools, information, case studies and best practices to help you in your jobs, taking advantage of best practices in real-world settings, vetted by an inter-disciplinary group of subject matter experts.
DIA: A Pioneer in Patient Engagement
In 2006, DIA was among the first organizations to recognize the importance of patient involvement in drug development and launched its first Patient Fellowship Program. Since then, the role patients can play in therapeutic product R&D has exploded. DIA continues to lead the way, providing input and insights into the evolution of therapeutic product development, and driving towards improved health and well-being throughout the world. DIA believes patients should be at the epicenter of the drug development life cycle, and for more than 15 years has pioneered efforts to advocate for the patient voice and discuss future patient engagement efforts across the health care continuum.
Bayesian Case Studies
The Bayesian case example repository, supported by the DIA Bayesian Scientific Working Group, contains a series of case studies demonstrating examples of the use and value of Bayesian statistics in medical product development.
Electronic Document Management Reference Model
DIA Community for Document and Records Management developed an initiative aimed at developing a taxonomy/metadata reference model that can ultimately be shared by biopharmaceutical organizations as a common starting point for building sustainable, shareable EDM repositories.
Framework for the Destruction of Paper 2.0
DIA Community for Document and Records Management has defined the critical requirements for destruction of paper records for better content management.
GMP Quality Systems Reference Model
Represents the combined work of DIA volunteers in the Document and Records Management community and provides a model of accepted practices across the industry for the organization (taxonomy) and metadata properties of GMP Quality Systems documentation. Can be used by any biopharmaceutical company as a common starting point for building sustainable, shareable repositories for the management of GMP Quality Systems documentation.
Trial Master File Reference Model 3.1
Represents the combined work of DIA volunteers in providing a model of accepted practices across the industry, and can be used by any company in an electronic or paper format.
Visual Model of Patient Engagement in Benefit-Risk Assessment through the Medical Product Life Cycle
Engaging patient stakeholders in benefit-risk decision making throughout the medical product life cycle is key to meeting patient needs. This visual model, created by participants of a 2015 DIA conference on this topic and partially funded by an Engagement Award from the Patient-Centered Outcomes Research Institute (PCORI), depicts how we are engaging patients in benefit-risk decision making and where stakeholder efforts can improve patient outcomes.