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APRIL 16/2019

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news roundup

FHI Clinical Launches Full-Service CRO

The new CRO operates as an independent, commercial subsidiary of FHI 360, an international nonprofit working to improve the health and well-being of people in the United States and around the world. FHI Clinical is headquartered in downtown Durham, North Carolina.


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Operational Challenges in Resourcing and Executing Seasonal Infectious Diseases Studies
North America: Thursday, June 13, 2019 at 11am EDT | 10am CDT | 8am PDT
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Medidata Launches Acorn AI

Medidata has launched a new company, Acorn AI, which plans to "make data liquid" across the entire drug lifecycle, from R&D to commercialization, using its AI capabilities to provide insights to the data.


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Operational Challenges in Resourcing and Executing Seasonal Infectious Diseases Studies
Europe: Thursday, June 6, 2019 at 3pm BST | 4pm CEST
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BioOptronics Launches Site Solutions to its Portfolio

Bio-Optronics has launched CCTrialSuite, integrated, patient-centric clinical research management products that complement the company's Clinical Conductor CTMS. The first two products are CCPay, a fully integrated payment solution for sites and CCText, an advanced text messaging solution for sites.


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Standardization Drives Transparency and Optimization of Contract/Budget Processes in Clinical Trial Startup
Tuesday, April 30, 2019 at 1pm EDT | 12pm CDT | 10am PDT
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Articles

A Roadmap for Implementing Risk-Based Monitoring and Quality Management

In this article, DIA Clinical Data Management (CDM)/Risk-Based Monitoring (RBM) Community presents a segment of its roadmap –specifically, pre-study risk planning, vendor selection, and change management in RBM and RBQM.


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Technology: Friend vs Foe - Considerations for Practical Execution of a Risk-Based Monitoring Strategy
Tuesday, April 23, 2019 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST
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Digital Pathology Platform for Clinical Trial Imaging

In this Q&A, Nathan Buchbinder, Chief Product Officer for Proscia, discusses the company's new digital pathology platform and how it positively impacts imaging needs in clinical trials.


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RBM Case Studies: How Artificial Intelligence and Machine Learning with Advanced Analytics are driving new levels of patient safety and study quality
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In this edition

Medidata Launches Acorn AI
FDA Moves to Modernize Drug Review Process
FHI Clinical Launches Full-Service CRO

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Fast, Focused Medical Data Review – Use Cases by a Medical Monitor
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Events

IRT Europe
Clinical Research as a Care Option
Clinical Trial Budgeting and Forecasting
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Minimizing the Impact of Human Error, Subjectivity, and Labor Costs The Application of Digital Pathology in Clinical Trials
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Blog Posts

FDA Moves to Modernize Drug Review Process

Under a new "knowledge management" approach for the Center for Drug Evaluation and Research (CDER), sponsors will submit applications that present data in a structured format so that it can be transmitted to teams of experts from multiple disciplines able to assess applications for new drugs and biologics in a timely and efficient manner.


Re-Imagining Integration for Quality Clinical Trials

Integrations are the current state of the art. Working toward better standardization enables sponsors and CROs to eliminate human error, prevent business disruption, create repeatability, ensures efficiency and quality, and keep patients safe.


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Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
Group Publisher
TBaker@mmhgroup.com