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Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.

uMotif worked with IDEO to shape a patient-centric approach by focusing on human-centered design.

As FDA continues to advance the role of patients in designing clinical trials with meaningful and accurate endpoints, it is seeking more input from stakeholders on how best to identify clinical outcomes most important to patients and caregivers.

Imagine you are in charge of European legislation on pharmaceuticals. Imagine you've been told to draft rules on how to conduct clinical assessments at European level to help measure the value of a medicine. What would you go for?

In this article, Crissy MacDonald reviews the key changes in ICH E6 (R2), discuss the challenges organizations are facing, and present actionable recommendations for organizations to implement now.

A new report on EU's digital health strategy also calls for closer coordination of national HTA arrangements-but both policy initiatives couldn't be more different.

FDA is joining with other federal health agencies and the biomedical community to advance science, regulatory policies, and reimbursement strategies to combat the need for new medicines for infectious diseases.

Success in developing targeted medicines means companies need a companion diagnostic strategy, the expertise, and more.

Q&A highlights one such example of M&A movement in the CRO space toward mid-sized companies focused in specific disease indications.

A multitude of data sources leaves clinical data management systems in catch-up mode-and researcher dizzy trying to follow the data- but there is hope for simplification on the horizon.

Key tips and resources to help evade the common traps of market landscaping-today an increasingly high-stakes and comprehensive task during clinical development.

Click the title above to open the Applied Clinical Trials October 2018 issue in an interactive PDF format.

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.