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In this ISSUE

Acknowledging Cycle Time Impact from Protocol Amendments

Six Predictions for 2019

Quality Control and Assurance

Regulatory Affairs
Brexit or no Brexit, it's an EMA Exit
The British government and the country's squabbling parliament are still incapable of deciding when–or even if–the UK should leave the European Union, still less how.
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Regulatory
FDA Policies Support Shift to Decentralized Clinical Trials
FDA Commissioner Scott Gottlieb supports approaches that help biomedical research "become more agile and efficient" and reduce the cost of developing therapies, including decentralized trials and how real world data (RWD) and real world evidence (RWE) to support a range of drug development goals.
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Calendar
/ Making Clinical Research an Element of Better Healthcare 2/19-2/20 /
/ 2019 Bridging Clinical Research & Clinical Health Care Collaborative 3/4-3/5 /
/ CRO Partnerships and Oversight Excellence 3/7-3/8 /
/ IRT Europe 4/16-4/17 /
/ Clinical Trial Budgeting and Forecasting /


Clinical Research
The Turning Point for Clinical Research: Global Data Standardization
Clinical research is only as effective as its ability to have an impact on health.
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Direct-to-Patient
Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts
A new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications. This paper poses a consensual review, fine-tuning, and validation of study classification while further clarifications on this law are sought out.
... /Read more/
GDPR
How Does GDPR Affect Clinical Trials
The EU General Data Protection Regulation is the most important change in data privacy regulation in 20 years.
... /Read more/
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Lisa Henderson
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Todd Baker
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