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In this ISSUE

Malaysia's Clinical Research Ecosystem

Tech-Driven Efficient Oversight of Vendors and Sites Performance

Are Clinical Trial Matching Services Truly Patient-Centric?

Regulatory Affairs
FDA Moves to Implement New Site Inspection Program
The FDA's Office of Regional Affairs will look to implement their much-anticipated Program Alignment initiative, thus reorganizing the FDA field force in 2017.
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Wearables
What Are You Wearing?
While wearable devices are mainly an advantageous way to collect data from monitoring a trial participant's progress, there are scientific and operational considerations to be aware of.
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Patient Centricity
Patient-Centric Methods for Tackling Clinical Trial IP Nonadherence
Nadir Benouali of MEDICODOSE Systems speaks about his experiences with investigational product nonadherence, its place in pharma and patient-centric ways to address it.
... /Read more/
Good Clinical Practices
Does Your CRO Comply with ICH E6?
With the new regulatory guidelines concerning GCP, questions have arisen as to how best RBM plans can comply.
... /Read more/
Regulatory Affairs
Provisions of the 21st Century Cures Act
The 21st Century Cures Act, passed in December, contains provisions that many have questioned and criticized.
... /Read more/
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Calendar
/ IISR 2017 - Investigator Initiated and Sponsored Research 2/13-2/14 /
PPhiladelphia, Pennsylvania
/ Meeting the Ethical Standards Under the Clinical Trials Regulation 2/21-2/22 /
Brussels, Belgium
/ Clinical Trial Budgeting & Forecasting 2/22-2/23 /
Philadelphia, Pennsylvania
 
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