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news roundup
CRO giant and leading healthcare information provider merge to create a wide-ranging R&D-to-commercial services company.
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BIOVISUALIZATION
Effective Mining and Interpretation of Laboratory Results Data
LIVE WEBCAST: Thursday, May 26, 2016 at 10 am PDT / 12 pm CDT / 1 pm EDT
 Free registration
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Duke Clinical Research Institute (DCRI) and SAS will give researchers access, analytics and data management tools to its database that includes 45 years of cardiovascular patient data collected by the Duke University Health System.
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ICH E6 (R2) Process and Technology Considerations for the New Risk Based Gold Standard
LIVE WEBCAST: Thursday, May 12, 2016 11:00 am EDT
 Free registration
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PharmaSeek is partnering with the Puerto Rico Consortium for Clinical Investigation (PRCCI).
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Keeping pace with immuno-oncology research breakthroughs and biomarker identification
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From eligibility to exploratory: Planning and implementing biomarker testing for Immuno-oncology trials
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Regulatory
CDISC announces a new standard that allows pharma to register their clinical trials from a single file into regulatory databases of the EMA, FDA and WHO.
Barring issues with drug efficacy or data quality, the top reasons for rejection are based on administrative issues.
The Drug Controller General of India (DCGI) has been working to amend and update its policies to stimulate growth in drug development in that country.
Increased focus on adherence to anti-bribery and anti-corruption laws makes compliance issues particularly important for clinical research conducted in foreign countries.
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Articles
This peer-reviewed article concluded that assessment of AEs’ causality is subjective and influenced by individual judgment of investigator/expert, and, thus, does not reflect a safety profile of the drug.
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Blog Posts
FHIR (pronounced “fire”) is a new standards-based framework and platform that makes it possible to tap directly into Electronic Healthcare Record (EHR) systems to retrieve and even create protected healthcare and administrative data.
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We are seeking article submissions with case studies/examples on Innovation, Patient-Centricity, EHRs, Study Start-Up, Site Selection, and more.
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