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New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy
Explore insights on new CMS policies & Medicaid's fresh clinical trial policy. Stay updated in a rapidly evolving healthcare landscape.
How to Design Digital Materials for Participant Engagement
Keeping a participant informed and engaged in any study is critical. This blog outlines how we can engage participants digitally.
Roles and Responsibilities of a Clinical Research Coordinator
Clinical Research Coordinators are tasked with many responsibilities throughout the day. Learn about balancing each role and responsibility effectively.
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative
Advarra Senior Consultant David Babaian, JD, was a co-author for an article appearing in Therapeutic Innovation and Regulatory Science.
Understanding the EU Clinical Trials Regulations Updates
The new European Union regulations have significant implications for sponsors submitting trials in the EU.
TriNetX and Advarra Partner to Provide Enhanced Site Selection Services
SiteIQ™ Plus Offering Equips Life Sciences Companies with Study Site and Principal Investigator Insights Paired with Patient Availability Information to...
Regulatory Considerations for Pharmaceutical Product Lifecycle Management
New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.
What Is a Screening Consent?
Study-specific screening consent is a subtype of informed consent, which ensures a research participant understands of the research and its risks.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.
Services For Sponsors & CROs
Advarra understands the unique needs of clinical research sponsors and contract research organizations (CROs).
Building Remote Workflows within eRegulatory Document Management: Subject Binders & SOPs
Advarra eRegulatory Management System now supports the storage and remote monitoring of Subject Binders and SOPs, increasing compliance, and centralizing your study documents.
How Paper and Electronic Source Data Meet ALCOA-C Principles
ALCOA ensures source data is safe and effective, but how does it differ for data collected on paper vs. electronically?