news roundup

Lyft Joins Continuum to Transport Trial Patients

Through the partnership of Lyft and Continnum Clinical, patients will be able to use the Lyft app to secure transportation to and from the trial site, free of charge.

PAREXEL Expands Managed Access Services

PAREXEL offers end-to-end services for Managed Access Programs that includes operational teams, global regulatory expertise, proprietary technology, and global clinical logistics to coordinate complex compassionate use or expanded access programs.

Pharma Selects Worldwide Clinical Trials for Phase III Trial

Aurinia Pharma has selected the CRO for its Phase III trial for the treatment of active lupus nephritis.

FDA Moves on New Site Inspection Program

FDA's Office of Regional Affairs (ORA), which manages the agency's 5,000 field inspectors, will implement a major reorganization of the FDA field force in fiscal year 2017, as promised.

Blog Posts

An Overview of the 21^st Century Cures Act

This article discusses provisions of the Cures Act that will successfully preserve conscionable safeguards of safety and efficacy, eliminate undue development hurdles, and increase patient access to breakthrough treatments.

Revised Common Rule Draws Praise and Criticism

To avoid excessive roadblocks to future research, the updated Common Rule drops the need for added informed consent for research involving non-identified biospecimens. And it continues to permit investigators to obtain waivers to consent requirements.

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Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com