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ACT

May 19/2020

news roundup

SubjectWell Opts In Patients Willing to Participate in COVID-19 Vaccine Trials

SubjectWell has developed a growing patient registry of individuals in the U.S. interested in participating in clinical trials for COVID-19 vaccines.


Peachtree Bioresearch Selects Oracle Cloud Services

CRO Peachtree BioResearch Solutions has selected Oracle Health Sciences cloud services to improve its clinical startup and management activities.


Latest Business News and People Moves

This month’s updates come from AiCure, CluePoints, Cytel, Datacubed Health, Illingworth Research Group, Parexel, and RAPS.


In this edition

Latest Business News and People Moves
Bridging the Gaps in CAPA Planning in Clinical Trials


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Bioforum, the Forum for EmergingBio's Outsourcing Decisions
As the biopharma industry traverses unchartered waters amid the COVID-19 crisis and doubles down on its efforts to bring new therapies to market faster, cheaper and without affecting quality, the success of strategic partnerships and functional service provider models will become more critical than ever before.
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Articles

DMCs Role in Data Integrity in COVID-19 Climate

Competent authorities are urging sponsors to utilize data monitoring committees (DMCs), if not already part of the study design, and regulatory agencies are issuing new and updated guidance as the situation evolves.


Bridging the Gaps in CAPA Planning in Clinical Trials

This article discusses bringing CAPA and RBQM together because they currently exist in silos. Within R&D organizations, CAPA management often sits on the quality assurance side of the business, while RBQM has evolved into its own multi-disciplinary area.


Blog Posts

Pandemic Highlights Urgency for New Methodologies for Evidence Generation

Ülo Palm, MD, PhD Senior Vice President, Digital Sciences, Allergan and Iya Khalil, PhD, Co-Founder and Chief Commercial Officer, GNS Healthcare discuss the need for statisticians, mathematicians, and computer and data scientists to come together and develop, with the tools of modern digital sciences, new 21st century methodologies for “substantial evidence” generation in a global health crisis.

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Lisa Henderson
Editor in Chief
LHenderson@mjhlifesciences.com

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Todd Baker
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TBaker@mjhlifesciences.com