ACT

JULY 09/2019


news roundup

Veeva Vault Safety Available

Veeva Systems announced Veeva Vault Safety, a cloud application for managing adverse events in real time.


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Real Patient Stories: The Trials of Finding Clinical Trials
For clinical trial sponsors, it can be frustrating trying to recruit participants for clinical trials. For patients, trying to find a clinical trial can be equally frustrating. Looking for studies online is like searching for a needle in a haystack. Patients and caregivers share their personal experiences in these candid interviews.
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ERT Participates in Mobility Loss Project

ERT, a global data and technology company in clinical trials, announced its involvement in a project to enhance drug development and improve the clinical management of mobility loss. The clinical research project — MOBILISE-D — will establish a roadmap to implement new digital tools for analysis of motion to identify, categorize, and monitor patient disability


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Operational Challenges in Resourcing and
Executing Seasonal Infectious Diseases Studies

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News Notes

News you may have missed from TransCelerate, Verily, ICON and more.


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Operational Challenges in Resourcing and Executing Seasonal Infectious Diseases Studies
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Articles

Optimizing Approaches for Clinical Research as a Care Option

In this article, the author examines the benefits of clinical research as a care option, and what needs to change in healthcare systems for this to occur—going beyond just increasing individual and physician awareness of clinical trials as a valid care option to integrating research into the healthcare ecosystem.


Response Adaptive Trial Design for Rare Diseases

Due to the expense of clinical trials, more and more pharmaceutical companies are becoming interested in Bayesian methods—in 2006, the FDA called for advances in trial designs, specifically the use of adaptive design methods and Bayesian approaches in R&D, which are especially useful for rare disease trials.


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In this edition

Nothing is Simple in the EC's Upgraded Clinical Trials Regulation
ERT Participates in Mobility Loss Project
Response Adaptive Trial Design for Rare Diseases

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Blog Posts

Nothing is Simple in the EC's Clinical Trials Update

The European Commission recently updated its guide to the 2014 clinical trials regulation, a "live" document that has been in constant development by the EU's group of clinical trials experts drawn from the member states, and is periodically updated as procedures become better defined. This latest version includes an extensive new section on safety, along with updates to the previous guidance.


Events

T3: Trials, Tech and Transformation
Direct-to-Patient Trials
4th Annual Lay Summaries Summit
Basket & Umbrella Trials for Clinical Oncology
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Ask the editor

Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
Group Publisher
TBaker@mmhgroup.com