ACT

DECEMBER 11/2018


news roundup

Certara Launches Trial Simulator 2.3

Certara, a provider of drug development, regulatory science, real-world evidence, and market access, announced the launch of version 2.3 of its Trial Simulator software in order to help drug developers test new trial design ideas for all phases of drug development.


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Outcomes in Focus: Best Practices for eCOA
This eBook covers considerations and practical advice for smooth eCOA implementation; secrets to eCOA success from industry insiders; and new opportunities for the use of eCOA in clinical trials.
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Research Partnership Publishes New Patient Living with Diabetes 2018 Report and New Reports Scheduled for 2019

A new report, Living with Diabetes (LATAM), is just one in a series of reports offering insights into the chronic disease patient journey from pre-diagnosis to stabilization.


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Introducing Cross-Trial Safety Notifications: Built for Efficiency, Vetted by Experience
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Synteract Acquires Pediatric CRO KinderPharm

Synteract, a CRO, has acquired KinderPharm, a pediatric CRO, focused on advancing pediatric drug development across all phases of clinical research. Together, Synteract and KinderPharm will deliver a single source model for preclinical and clinical development, for working with children and their families.


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Introducing IQVIA ICF Author: The Power to Do Patient Consent Your Way
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Europe Mulls Rival Approaches to Tackling Disease

Policy discussions include focus on targeted treatments on one side and wider access and prevention-over-treatment on the other.

In this edition

Europe Mulls Rival Approaches to Tackling Disease
Direct-to-Patient Clinical Trials: Strategies for Success
BMS Operationalizes Study Connectivity
Multiple Expansion Cohort Clinical Trials: A Shorter Path to Success for Oncology Drugs

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Cellular Biomarkers: Predicting Clinical Trial Outcomes Through the Understanding of T-cell Responses in the Human Challenge Model
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Events

14th Biosimilars Summit
Clinical Data Disclosure and Transparency
Patient Registries and Real-World Evidence Summit
DIA Europe 2019
Search Upcoming Events

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The Potential for Disease-Modifying Therapies in Parkinson's Disease
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Cellular Biomarkers: Predicting Clinical Trial Outcomes Through the Understanding of T-cell Responses in the Human Challenge Model
On Demand
Learn More


Articles

Direct-to-Patient Clinical Trials: Strategies for Success

The growth in the use of Direct-to-Patient clinical trials and the strategies pharmaceutical manufacturers should consider when implementing this model.


The Basics of Clinical Trial Centralized Monitoring

Examining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.

Blog Posts

Blockchain Use in Research

The core tenets of blockchain technology–a decentralized and encrypted way of distributing, sharing, and storing information–seem appealing for health data.


BMS Operationalizes Study Connectivity

In this interview, Carolyn Brehm, BMS Study Connect Business Lead, discusses how BMS is helping to match patients with studies through Study Connect.


Oncology

Multiple Expansion Cohort Clinical Trials: A Shorter Path to Success for Oncology Drugs

The rapid rise of targeted drugs and biologics in oncology has spurred sponsors and the FDA to innovate, leading to the creation of a variation to the typical trial design that can include multiple expansion cohorts.

Medidata Rave Omics Collaborate on Rare Disease Research

The Castleman Disease Collaborative Network (CDCN) discovered new patient subgroups, based on previously unknown proteomic signatures, with Medidata's Rave Omics, a machine learning-based solution. These discoveries, presented at the 60th Annual Meeting of the American Society of Hematology, provide insights into treatment response and potential new drug targets.


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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