ACT

OCTOBER 16/2018

news roundup

Release of ADDPLAN neo Announced by ICON

ICON, a provider of drug development services, announced the release of ADDPLAN® neo, providing a technology platform for design, simulation, and analysis of adaptive clinical trials. The new release combines three modules, ADDPLAN® BASE, ADDPLAN® MC, and ADDPLAN® DF to become integrated under one robust framework.

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Cellular Biomarkers: Predicting Clinical Trial Outcomes Through the Understanding of T-cell Responses in the Human Challenge Model
North America: Tuesday, November 13, 2018 at 11am EDT | 10am CDT | 8am PDT
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BioIVT Acquires Clinical Trials Laboratory Services

BioIVT, a provider of research models and services for drug development, announced that it has acquired Clinical Trials Laboratory Services, a donor center and laboratory based in London, UK. With this acquirement, BioIVT hopes to ship high quality blood products and blood-derived immune cells efficiently to researchers throughout Europe.


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Cellular Biomarkers: Predicting Clinical Trial Outcomes Through the Understanding of T-cell Responses in the Human Challenge Model
Europe: Thursday, November 8, 2018 at 3pm GMT | 4pm CET
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New Whitepaper Outlines Patient Benefits of NHS High Throughput Centres

A new whitepaper has been released outlining the substantial benefits NHS High Throughput Centres could bring to UK patients, the NHS, and UK PLC. The set-up of High Throughput NHS Centres is potentially crucial in making the UK competitive after Brexit as it aspires to make the UK the country of choice for clinical research.


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Neuropathic Pain Studies: Patient Selection, Study Design, and Clinical Trial Challenges
Tuesday, November 6, 2018 at 11am EST | 8am PST | 4pm GMT | 5pm CET
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FDA Renews and Expands its Use of Certara Software

Certara, a provider of drug development, regulatory science, market access, and real-world evidence solutions, announced that the US Food and Drug Administration has renewed its number of Certara software licenses such as Certara Phoenix, Simcyp, and Synchrogenix GlobalSubmit, for reviewing new drug and biologics applications.


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IDENTIFYING NASH PATIENTS: Solutions and Strategies
Thursday, November 1, 2018 at 11am EDT
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A Pan-cancer View of Immune Cell Activity, Immune Checkpoints, and Tumor Mutational Burden
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In this edition

FDA Renews and Expands its Use of Certara Software
Patient Engagement Surveys in Clinical Trials: Dos, Don'ts, and How They Help
Clinical Trial Innovation Update

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On the brink of change: How academic data and machine learning can revolutionize Alzheimer's drug development
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Events

Basket and Umbrella Trials for Oncology
IRT 2018
eCOA / ePRO 2018
Women of Color in Pharma Second Annual Conference
2018 HBA Annual Conference
Independent Expert Committees
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Research Reveals Data Quality Issues Slow Clinical Trial Progression – What Can You Do To Prevent This?
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Artificial Intelligence: A Transformative Journey for Pharmacovigilance
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Articles

Patient Engagement Surveys in Clinical Trials: Dos, Don'ts, and How They Help

This article will address concerns and look at how the pragmatic implementation of surveys in today's clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.


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Challenging the Status Quo: The Diffusion of Technology in Study Startup
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Human Centered Design–A Pathway to Patient Centricity

uMotif worked with IDEO to shape a patient-centric approach by focusing on human-centered design.

Blog Posts

Hands Across the Sea for EU-US GMP

The mutual recognition agreement between the European Union and the US FDA now covers 15 European countries, after Portugal won US recognition in mid-September.


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A Next Generation Sequencing Approach to Influenza Vaccine Development
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Clinical Trial Innovation Update

This article will summarize the discussion on innovation such as information exchange, RBM, and big data analytics, that took place at this years Cambridge Health Institute's Clinical Trial Innovation Summit.

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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