ACT

May 09/2017


news roundup

RAPS Seeks to Raise its Profile in Europe

RAPS plans to spend more than 2 million euros over the next three years by launching new events and resources to serve the needs of regulatory professionals in the region.


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Build a trial around patients, not technology. Learn how a modern EDC helps deliver complex studies and improve data collection in this white paper. Read now.


WIRB-Copernicus Acquires ThreeWire

WIRB-Copernicus Group announces the acquisition of ThreeWire, a global patient recruitment, enrollment and retention firm that assists biopharma, medical device companies and CROs achieve trial enrollment and retention goals.


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Planning Gene Therapy Research? Prepare for institutional biosafety committee (IBC) Review with these tips from the Biosafety Officer at a leading IRB.
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Adventist, Bio-Optronics Partner on CTMS

Adventist Health System and Bio-Optronics announce the implementation and rollout of the Clinical Conductor Clinical Trial Management System (CTMS) at two of the health care system's research institutes.


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Winning the RAT race: A new Center of Excellence to drive development of regenerative medicines
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Commonwealth Informatics Launches Big Data Offering

The Commonwealth Vigilance Workbench (CVW) Longitudinal assists drug researchers and regulators explore and refine safety signals using evidence from healthcare data sources.

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In this edition

Orphan Drug Surges Raises Regulatory Challenges
Analysis of EMA Anonymization Practices
WIRB-Copernicus Acquires ThreeWire
Oncology— George Clinical Acquires Vector Oncology

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Talking the Patients' Language – the importance of effective, patient-centered engagement
Live Webinar: Tuesday, June 6 at 8:00am EDT
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Events

Transformative Trial Models and Engagement
Global Risk-Based Monitoring, Barcelona
IRT 2017
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Blog Posts

Patient Centricity and Convenience: Request a Lyft

Continuum Clinical recently partnered with Lyft to deliver the convenience of transportation directly into the hands of patients. Nariman Nasser, VP of Site Optimization at Continuum Clinical, elaborates on the partnership in this interview.


Fighting Back Against Drug Skepticism

In a world given over dangerously to social-media sensationalism, systematic distrust of science, and blind acceptance of fake news, vaccine deniers are gaining ground.


Oncology

George Clinical Acquires Vector Oncology

George Clinical, a full-service CRO in the Asia-Pacific region, has acquired Vector Oncology's Pharma Services Division, to provide oncology services in that region.


Orphan Drug Surges Raises Regulatory Challenges

Orphan drugs will account for more than 21% of worldwide brand-name prescription drug sales in 2022, up from 6% in 2000, according to an analysis by EvaluatePharma.


Developing New Endpoints for Immuno-oncology Studies

Drug developers are using surrogate endpoints to monitor the effectiveness of immunotherapies, taking into account the differences between immunotherapy and traditional treatments.

Articles

Analysis of EMA Anonymization Practices

This article provides a descriptive analysis of what we have learned from EMA data releases over the first three months in terms of approaches to anonymization, how the EMA anonymization guidelines are being implemented by manufacturers, and how patient privacy is balanced against data utility.


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Is Your CTMS Working for You? Unify and Optimize Your Approach to Clinical Trials
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Regulatory Debate Around Pre-Approval Product Access

The FDA tries to strike the balance, and/or accomplish the goods of society and the individual patient through its evolving expanded access program. This program, under certain conditions and criteria, gives patients access to investigational products not approved for marketing. But there is ongoing dialogue about achieving the right balance for this access.



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Lisa Henderson
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Mike Tessalone
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