Designing a patient-centric protocol

Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap

Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap | Stegemann et al Read more…

By Lindsey, ago

Patient Experience: Gratitude Toolkit

Patient Experience: Gratitude Toolkit Patient Experience: Gratitude Toolkit | TransCelerate TransCelerate, in partnership with patients/care partners, sites, and industry sponsors, developed the Gratitude Toolkit (GRAT), a set of deliverables that sponsors, with their site partners, can leverage to acknowledge and show appreciation to clinical trial participants. The GRAT streamlines options Read more…

By Lindsey, ago

Personalized Clinical Trials Framework

Personalized Clinical Trials Framework Personalized Clinical Trials Framework | TransCelerate TransCelerate’s interactive Personalized Clinical Trials Framework is a set of practical considerations to support the R&D ecosystem (i.e., sponsors, sites, third parties, and other clinical trial stakeholders) with understanding and evaluating options that enable a more personalized experience for clinical Read more…

By Lindsey, ago

Patients Drive Authentic Trusted Solutions for Inclusive Clinical Trials

Patients Drive Authentic Trusted Solutions for Inclusive Clinical Trials Patients Drive Authentic Trusted Solutions for Inclusive Clinical Trials | Article “A recently launched peer reviewed publication in Current Breast Cancer Reports which highlights Tigerlily’s Clinical Trial capabilities. Tigerlily believe that it is critical to engage all parts of the community Read more…

By Lindsey, ago

Case Studies | MRCT Center of Brigham and Women’s Hospital and Harvard

Case Studies Case Studies | MRCT Center of Brigham and Women’s Hospital and Harvard The MRCT Center worked with stakeholders to develop case studies that illustrate efforts for diversity, equity, and inclusion that have been successfully integrated into the clinical research enterprise, and examples of therapeutic response differences that warrant Read more…

By Lindsey, ago

Determining Fair Market Value: Demystifying the Methodology Behind Patient Renumeration

Determining Fair Market Value: Demystifying the Methodology Behind Patient Renumeration Determining Fair Market Value: Demystifying the Methodology Behind Patient Renumeration | PFMD Reviews the challenges and opportunities that arise when seeking to co-create a global methodology and framework for patient FMV that is deemed fair, transparent, and ethical. View Here

By Lindsey, ago

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use | ICH ICH unites global regulators and the pharmaceutical industry to develop guidelines for safe, effective medicines. Established in 1990, it has grown to include 21 Read more…

By Lindsey, ago

Patient Focused Medicines Development (PFMD)

Patient Focused Medicines Development (PFMD) Patient Focused Medicines Development (PFMD) “Information on PFMD, A global collaborative and non-competitive coalition to Improve global health byco-designing the future of healthcare for patients with patients.The PFMD network is making sure to aggregate existing knowledge and tools, identifying good practices and coherently combining them Read more…

By Lindsey, ago

CTTI and FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials

CTTI and FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials CTTI and FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials | FDA An overview of a March 2019 CTTI and FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives Read more…

By Lindsey, ago

Enhancing Benefit-Risk Assessment in Regulatory Decision-Making

Enhancing Benefit-Risk Assessment in Regulator Decision-Making Enhancing Benefit-Risk Assessment in Regulatory Decision-Making | FDA An FDA guidance intended to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Agency makes about Read more…

By Lindsey, ago
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