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Publications

ACRES team members have contributed articles to a variety of well-respected life science and biomedical publications

Vulnerability and Clinical Research: Mapping the Challenges for Stakeholders

Beyond what are characterized as Special Populations in U.S. FDA regulatory considerations is vulnerability of patient populations in a broader context of international guidance. Such a review suggests a rich appreciation for the diversity of patients.

The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams

The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide.

Accreditation of Clinical Research Sites — Moving Forward

An initiative to design a system of accreditation that would improve and ensure the quality, performance, and safety of clinical trial sites is now coming to fruition.

Can Pharmacovigilance Learn From the Oil and Gas Industry, Which Has Been Outsourcing for Over a Century?

Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for initiating as well as maintaining an outsource relationship.

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