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Q&A: The IND Journey Phase I – Navigating Success
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.
IBC vs. IRB: What’s the Difference?
Gene therapy research is full of promise, but because of the risks, it’s a highly regulated space requiring oversight by an institutional biosafety committee (IBC).
Beginner’s Guide to Clinical Trial Billing Compliance
Ensuring proper compliance within clinical trials is confusing, so here are best practices to ensure charges and claims are correctly routed
Surprise! “Checking the Box” Is Still an Option on the Federalwide Assurance (FWA)
Checking the box is still an option on the FWA. At this time, institutions must carefully consider whether it makes sense to check the box.
Advarra Acquires Forte:
What You Need to Know
On September 5, 2019, Advarra announced its intent to acquire Forte.
Component Analysis: Analyzing Benefits and Risks of Individual Interventions to Ensure Appropriate Research Participant Protections
A major element of any IRB review is the examination of potential benefits and risks to study participants.
Defining Decentralized Clinical Trials and Understanding Their Nuances
It’s important to understand decentralized clinical trials are not one-size fits-all and oftentimes a hybrid approach is necessary. Read our latest blog outlining what to consider when rolling out decentralized clinical trials across multiple jurisdictions where laws, technological uptake, and populations will vary.
Advarra Acquires IntegReview: What You Need to Know
On November 9, Advarra announced its acquisition of IntegReview. The combined organization leverages strengths in supporting the research community with client service,...
A Look at the Processes Behind Clinical Endpoint and Event Adjudication
Take a closer look at how and why we leverage proprietary, custom, and intelligent technology in our EAC program
Protocol Feasibility to Promote Trial Efficiency
Many studies do not accrue subjects at the site level, which contributes to a significant amount of waste of staff time and monetary resources. Read more:
4 Questions to Ask When Establishing a Pharmacovigilance Organization
Four common but critical questions for emerging biotech organizations establishing a pharmacovigilance (PV) organization.
4 Questions to Ask When Evaluating Your Research ROI
Return on investment (ROI) is a critical metric for clinical research leadership. Read more for questions to ask as you evaluate your ROI.