ACT

MAR. 15/2016

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news roundup

WIRB-Copernicus Acquires Clintrax Global

Clintrax Global is a services provider for negotiating clinical trial-related contracts and budgets between biopharmaceutical companies, CROs and investigator sites.


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Acquiring, Tracking and Maintaining Biological Study Samples for Complex Study Designs
LIVE WEBCAST: Thursday March 17, 2016 at 10:00 am PDT / 12:00 pm CDT / 1:00 pm EDT
Beyond sample tracking – have the peace of mind of knowing where your samples are throughout their lifecycle and ensure data integrity at every stage.
Register for free


goBalto, MCC Join to Benchmark Study Start-Up

The Metrics Champion Consortium's (MCC) Leadership program, a collaboration of member companies that define industry benchmark measures for Life Science organizations engaged in starting clinical trials.

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Advancing Drug Development with Digital Health
4 Key Ways to integrate Patient - Generated Data into Trials

LIVE WEBCAST: Wednesday, March 16, 2016 at 11:00 am ET
Are you ready to advance drug development with digital health? Register for this webinar to hear Medidata and Validic discuss how you can start leveraging participant-generated data in four key areas to streamline trials.
Free registration for this event


Almac Opens CDx Lab in North Carolina

The CLIA-accredited laboratory will support the downstream delivery of assays for patient testing and will operate both research-use-only and clinical diagnostic tests.


Regulatory

Califf Seeks Better Labels That Inform

Califf has a ready platform to discuss such strategies for improving clinical trial methodology, execution and evaluation as part of the larger goal of developing more innovative treatments for patients.


EMAs Approach to Early Drug Access

Early advice meetings could lead to improved clinical trial designs should ease data generation and the evaluation of applications for marketing authorization.

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In this edition

WIRB-Copernicus Acquires Clintrax Global
Almac Opens CDx Lab in North Carolina
TransCelerate CEO Discusses BioCelerate
Regulatory-Califf Seeks Better Labels That Inform

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Introducing A Faster, Easier, and More Effective Approach to Risk-Based Monitoring
LIVE WEBCAST: Tuesday, March 15, 2016 at 11:00 am ET
Oracle Health Sciences' holistic, advanced clinical trial solutions for data collection, management, and analysis help optimize research, mitigate risk, monitor/report adverse events, and drive medical insight for precision medicine
Free registration for both events


Events


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FDA Sentinel to Expand to Support Clinical Research

New developments reflect Sentinel's broader goal of providing a more active national system for biomedical safety monitoring.


Alternative Path to TQT Studies

From the FDA's perspective, if a sponsor submits QT data to a regulator, which meets certain defined standards, as described in the ICH revision document, it may seek a waiver from having to conduct a TQT study

Articles

TransCelerate CEO Discusses BioCelerate

Because of TransCelerate successes addressing shared industry challenges, says Dalvir Gill, other parts of R&D can also benefit from a similar collaborative approach.


Blog Posts

Genomic Data Too Valuable to Hoard

DNA testing company Ambry Genetics is launching a free online database that unlocks the human genome information of 10,000 of its customers.


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Lisa Henderson
Editor in Chief
lhenderson@advanstar.com

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Mike Tessalone
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