ACT

April 10/2018


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news roundup

Removing the Risks from Adaptive Pathways: Planning for the Possible?

Peter O’Donnell weighs the varying views in Europe on the risks of going the adaptive pathways route for drug approval.


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Protein Biotherapeutic BioAnalysis, by Immunoaffinity LC–MS: Latest Trends and Recommendations
Live Webcast: Tuesday, May 15, 2018 11am EDT | 8am PDT 4pm BST | 5pm CEST
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Collaboration and Transparency Key to More Effective Clinical Research

Jill Wechsler details the two chief reasons why clinical trial quality and efficiency has improved in recent years.


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Six Strategies for More Accurate Clinical Trial Forecasting & Budgeting
Live Webcasts: Wednesday, April 25, 2018 at 11am EDT
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Europe Adds More Voices to Orphan Drug Push

Rare disease interests in Europe add more voices to push for greater backing of research incentives, infrastructure.


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Where Expertise Meets Nuance: Conducting PTSD Clinical Trials
Live Webcast: Tuesday, April 24 at 11:00am EDT
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How Social Media is Transforming Pharma and Healthcare

Outlining the growing attention and pursuits around social media in adverse event reporting and advancing patient-centric initiatives in clinical trials.


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Move Your Immuno-Oncology Therapy Forward in 2018 and Beyond
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Scientific Advice with Regulators – An Essential Tool in Early Drug Development
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In this edition

Europe Adds More Voices to Orphan Drug Push
Optimal Strategies for Compliance with EMA Policy 0070 on the External Publication of Clinical Data
Clinical Trial Quality and Compliance Update
Master Protocols in Oncology: A Review of the Landscape

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Patient-Centric Complex Trial Design & Site-Less Visits: How Study Design & IRT Can Ease Patient Burdens
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Events

IRT Europe 2018 - Interactive Response Technologies in Clinical Trials
Clinical Trials in Central and Eastern Europe Forum 2018
FDA Advisory Committee Master Class
4th Annual Endpoint Adjudication
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Managing the Placebo Problem in Chronic Pain Studies
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Articles

Optimal Strategies for Compliance with EMA Policy 0070 on the External Publication of Clinical Data

With the EU’s new General Data Protection Regulation coming into force in May this year, the impetus for life sciences firms to cement their data management strategies has increased.


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PV Research Reveals Momentum Towards Cloud and AL
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Millennials and their Impact on Clinical Research

The importance of examining this generation's influence on the clinical trial value chain.


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The Benefits of a Data-driven Approach to Feasibility
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Blog Posts

New Janssen Study Reveals Consent Insights

At ExL’s CROWN Congress, Cassandra Smith, Associate Director, Investigator & Patient Engagement at Janssen, discussed results from a study they conducted with patients on consent content modification.


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Achieve Better Early Clinical Development Outcomes - Faster
Use existing global network site relationships for improved early phase quality, costs and timelines
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Clinical Trial Quality and Compliance Update

The topic of clinical trial quality and compliance continues to evolve in clinical operations, based on discussions at ExL’s 9th Proactive GCP Compliance Conference.


Oncology

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.

 

Certara Launches Quantitative Systems Pharmacology Consortium on Immuno-oncology

Certara announced the launch of its Quantitative Systems Pharmacology (QSP) Immuno-oncology Simulator Consortium.


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Ask the editor

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

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Todd Baker
Group Publisher
todd.baker@ubm.com