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OCTOBER 09/2018

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news roundup

TrialScope Launches Clinical Trial Transparency Service

TrialScope, a company specializing in clinical trial transparency and compliance solutions, announced the launch of its Clinical Trial Transparency Service (CTTS) for sponsors. The new service hopes to improve patient engagement, lower costs, and increase transparency through a clinical trial publication website.

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Catalent Selected to Provide Oral Delivery Systems

GB Sciences, Inc. and Catalent Pharma Solutions announced that GB Sciences has selected Catalent to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacturing of GB Sciences' proprietary active pharmaceutical ingredients for its Parkinson's disease therapies.


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Medidata and Decibel Therapeutics Announce Multi-Year Collaboration

Medidata announced that Decibel Therapeutics is adopting Medidata Cloud and specifically using its eTMF and eCOA/ePRO solutions. The agreement will support Decibel Therapeutics' clinical development for hearing loss, tinnitus, and balance disorders.


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ActiGraph Launches New Activity Monitor

ActiGraph has announced the launch of its newest activity monitor, the CentrePoint Insight Watch. This watch hopes to deliver high quality, real-world data, and an enhance patient experiences during clinical drug trials and health research studies.


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In this edition

ActiGraph Launches New Activity Monitor
Comparing Risk Based Monitoring and Remote Trial Management vs. SDV
An Introduction to BYOD: What You Need to Know in a Snapshot
Pediatric Oncology Clinical Trials in Sub-Saharan Africa

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Other News

Covance Opens Companion Diagnostics Lab

LabCorp announced that its Covance Drug Development business will open a companion diagnostics lab in Morrisville, North Carolina. The facility also includes a genomics and molecular pathology lab to support clinical trials and diagnostic testing development, and houses manufacturing facilities for diagnostics materials and testing components.


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EMA Plans Relocation, Delays CT Portal Launch

In anticipation of relocating, the EMA has started on the re-distribution of the workload relating to the evaluation and monitoring of medicines to ensure the quality of EMAs scientific assessments and compliance with legal timelines Additionally, the EMA announced that the EU clinical trial portal and database’s go-live date has been postponed, due to technical issues with the IT systems.


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Articles

The Conversation ‘Before’ the Clinical Trials Conversation

This study looks at in-office conversations earlier in the patient journey toward a clinical trial, before suitable trial options have been identified or patient eligibility for a study has been established. These early conversations set the stage for patients’ understanding of and receptivity toward enrolling in a clinical trial in the future.


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The Conversation ‘Before’ the Clinical Trials Conversation

This study looks at in-office conversations earlier in the patient journey toward a clinical trial, before suitable trial options have been identified or patient eligibility for a study has been established. These early conversations set the stage for patients’ understanding of and receptivity toward enrolling in a clinical trial in the future.


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Oncology

Pediatric Oncology Clinical Trials in Sub-Saharan Africa

The region is significantly underrepresented in clinical development activity targeting childhood cancer.

Master Protocols in Oncology: A Review of the Landscape

With technology's increasing ability to gather and analyze previously unmanageable data sets, and medicine's forays into genomics and targeted therapies, the time of the master protocol may be at hand.

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Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Todd Baker
Group Publisher
todd.baker@ubm.com