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ACT

June 7/2016

news roundup

Q1 2016 Shows Continued Hiring Demand

According to ZRG Partners' Global Life Sciences Hiring Index, activity continues to grow, posting over 20% higher than a year ago.

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NORD’s Rare Diseases and Orphan Products Breakthrough Summit is the most meaningful multi-stakeholder event – historically featuring over 20 speakers from the FDA, participation from over 80 patient organizations and the Pharma/Biotech industry’s foremost experts in orphan product innovation, investment and commercialization.

The 2016 Summit is your opportunity to address the progress and innovations in rare disease diagnosis, treatment, engagement and access of orphan products.
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WCCT Merges with Specialty Oncology CRO Medelis

WCCT Global and Medelis will help sponsors navigate the complexities of global oncology and immuno-oncology drug development.

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The State of Risk-based Monitoring (RBM)
Live Webinar: Tuesday, June 21, 2016 at 11 am – 12 pm EDT
Register Free


Quintiles Offers Precision Enrollment

The new model is designed to accelerate site start-up and patient recruitment in oncology clinical trials and only opens a site after a patient is identified.

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In this edition

Low Success Rates Persist in Clinical Trials
Quintiles Offers Precision Enrollment
Q1 2016 Shows Continued Hiring Demand
Regulatory—Califf Seeks Evidence to Guide Regulatory Decisions

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Regulatory

CAPA As a Tool to Prevent a Warning Letter

This article offers tips on how a CAPA program is a critical tool in response to an FDA Form 483 and can prevent a Warning Letter.

Califf Seeks Evidence to Guide Regulatory Decisions

Prospectively designed registries and cohort studies are valuable, along with RCTs to guide clinical practice.

CDISC's Clinical Trial Registry Standard

The standard allows sponsors to build applications that generate submissions for multiple, global clinical trial registries; specifically for WHO, EMA and ClinicalTrials.gov from a single file.

EMA's Annual Report Features a Different Script

The European Medicines Agency departed from the tradition of tame complacency in its annual report published in mid-May, and featured non-official reflections from some distinctly non-official sources.

Blog Posts

Low Success Rates Persist in Clinical Trials

Cancer programs fare worse than average, and a large proportion of Phase III studies fail to support market applications.

Identity Trust in Clinical Trials

One use allows investigators to use a single identity that can be recognized across business, government and academic entities.

What Does Innovation Mean to You?

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Events

Publication and Clinical Trial Disclosure
Risk-Based Trial Management and Monitoring
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BIOVISUALIZATION
Effective Mining and Interpretation of Laboratory Results Data

On Demand
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Articles

Growing Availability of Wearable Devices

Broad consumer use of wearable devices is building familiarity and will facilitate the implementation of similar medical grade devices in clinical studies.

Disruptive Technologies in Drug Development

This article discusses which emergent technologies have the potential to further disrupt the clinical trial process.



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Lisa Henderson
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Mike Tessalone
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