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MAY 07/2019


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news roundup

Proscia Releases Update to its Digital Pathology Platform

Proscia has released the latest version of Concentriq, the company's digital pathology platform, which includes performance analytics module alongside a new suite of automation features.


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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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Frenova Adds Renal Research Center in Nevada

Frenova Renal Research, a division of Fresenius Medical Care North America (FMCNA), has added The Las Vegas site of Nevada Kidney Disease and Hypertension Centers to its available centers for its contract clinical research services. The facility features 24 physicians, 2,000 ESRD patients, and 15,000 CKD patients to the program.


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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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Michael J. Fox Foundation, 23andMe Launch Research Data Platform

The Michael J. Fox Foundation for Parkinson's Research (MJFF) and 23andMe have launched the Fox Insight Data Exploration Network (Fox DEN), the data access and analytics platform for Fox Insight, an online clinical study sponsored by MJFF. Fox DEN contains patient-reported outcomes, de-identified genetic data and data exploration tools from the largest cohort in Parkinson's disease research. All research data is de-identified and participant-consented for data sharing in Parkinson's research.


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Refocusing on Risk Mitigation in Starting Clinical Trials
Tuesday, May 28, 2019 at 1pm EDT | 12pm CDT | 10am PDT
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CRF Bracket Launches New Visual Planning Module

CRF Bracket's SmartSupplies Planning module allows for graphs for clinical supply and demand at the project and program levels using real-time forecast data pulled from the SmartSupplies Forecasting module, or other external sources such as simulation tools and spreadsheets.

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Challenges in Biosimilar Bioanalytical Assays and Sample Processing
Wednesday, May 15, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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In this edition

War On Cancer Takes Stage in EC Election
Frenova Adds Renal Research Center in Nevada
What is FDA's Pre-Certification Program for Digital Health Devices?

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Standardization Drives Transparency and Optimization of Contract/Budget Processes in Clinical Trial Startup
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Articles

Fundamental Changes Required for Clinical Research as a Care Option

In this article, the author describes three key considerations for the concept of clinical research as a care option (CRAACO) to succeed.


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Challenges in Biosimilar Bioanalytical Assays and Sample Processing
Tuesday, May 21, 2019 at 2:30pm IST | 5pm CST | 6pm JST
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What is FDA's Pre-Certification Program for Digital Health Devices?

In this article, the authors outline the third iteration of the FDA's Digital Health Innovation Action Plan, the Pre-Cert program. This program's documents were released in January and detail the proposed regulatory framework for the program, as well as the agency's plan to test the model.


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A new way to assess changes in trial complexity, success and duration: The Clinical Development Productivity Index
Tuesday, May 21, 2019 at 11am EDT
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Blog Posts

War On Cancer Takes Stage in EC Election

Columnist Peter O'Donnell offers his take on Manfred Weber's, a German MEP who is bidding to become the president of the European Commission in November, "European Master Plan against Cancer."


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Technology: Friend vs Foe - Considerations for Practical Execution of a Risk-Based Monitoring Strategy
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Events

4th Annual Managed Access Programs and Accelerated Pathways
BIO International Convention
Rare Disease Innovation and Partnering Summit
DIA 2019 Global Annual Meeting
Direct-to-Patient Trials
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Lisa Henderson
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Todd Baker
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