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ACT

APR. 5/2016

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news roundup

Take Our Survey on Paperless Trials


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Immuno-Oncology Insights:
Top 5 Challenges in Today's Immuno-Oncology Trials

Live webinar: Thurs., April 7, 2016 at 11 am – 12 pm EDT
Learn about the top 5 challenges of immuno-oncology clinical trials, and get practical insights for your clinical development program.
Register now


Study Start-Up Platform from goBalto

goBalto offers a platform for cloud-based study startup clinical trials, from site feasibility assessment and selection through to activation, with metrics to track adherence to timelines and budget.


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Overcoming regulatory and statistical hurdles of biosimilars drug development
Designing smarter trials

Live webinar: Wed., April 6, 2016 at 11 am
Register here


In this edition

Take Our Survey on Paperless Trials
Study Start–Up Platform from goBalto
3 Factors Affecting FDA Inspections
RBM-Central Monitor: A New Role in RBM

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Acquiring, Tracking and Maintaining Biological Study Samples for Complex Study Designs
On Demand
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articles

CTMS: What You Should Know

Many organizations have a constant need to expand CTMS capabilities, integrate clinical operations data across multiple systems, and update clinical trial processes.

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Mitigating risk using Risk-based Monitoring
On Demand
Learn how risk-based monitoring (RBM) is transforming clinical development by mitigating risk while optimizing execution. Understand how to achieve enhanced patient safety with improved quality to execute your RBM studies with confidence.
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Blog Posts

3 Factors Affecting FDA Inspections

The outcome of any inspection or audit is a blend of the compliance level of the inspected site, Inspector/Auditor and reviewing agency competence, and how well the audit or inspection is managed.

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Advancing Drug Development with Digital Health
4 Key Ways to integrate Patient - Generated Data into Trials

On Demand
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RBM

Central Monitor: A New Role in RBM

Considering the scope of centralized monitoring and RBM processes, the central monitor role has key responsibilities and attributes.

Wingspan eTMF Features Monitoring Solution

Wingspan eTMF’s newest release features a placeholder feature for visit documents, as they are scheduled.

Keep RBM Approach Simple

When applying a risk-based approach to clinical trials, one needs to identify the risks to the critical data and processes that are very important to achieve the study objectives.


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Lisa Henderson
Editor in Chief
lhenderson@advanstar.com

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Mike Tessalone
Publisher
mtessalone@advanstar.com