Medical and Regulatory Affairs
Protected: PREMIER VOICES #15: Understanding EU Regulatory Requirements in Gene Therapy Development
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Tag: real-world evidence
Consulting
Entering a New Clinical Phase of Non-Traditional Data Sources
This is part two of a two-part series based on our recent webinar Setting a Real-World Strategy in an Evolving Clinical Research Environment. You can read part one here. In this post, we will cover non-traditional data points, their use in randomized control trials (RCTs), and how they contribute to a successful data strategy. The...
Clinical Research: Phase 1 - Phase 4
Premier Insights From WODC
Watch Premier Research’s presentations from World Orphan Drug Congress 2020 below. Note: You must be logged into your WODC Swapcard account to view presentations Rare Disease Recruitment: Addressing Enrollment Hurdles and Differentiating Your Clinical Trial in an Increasingly Competitive Research Environment Jonathan Kornstein, Executive Director, Program Strategy, Rare Disease & Pediatrics, shares tips for overcoming...
Clinical Research: Phase 1 - Phase 4
PREMIER VOICES #14: Setting a Real-World Strategy in an Evolving Clinical Research Environment
Featured Guests Stacy WeilSenior Vice President,Clinical Data Operations, Strategic Business Optimization Stacy Weil translates Premier Research’s strategy into actionable data initiatives that enable internal and external customers to achieve the highest level of performance and success. Prior to joining Premier Research, Ms. Weil was Vice President of Clinical Data Operations at PatientiP.Read More Nach Davé,...
Consulting
Can Your Clinical Data Strategy Keep Pace?
Following up on our recent webinar Setting a Real-World Strategy in an Evolving Clinical Research Environment, this is the first of two blogs on this critical topic. In this post, we’ll cover the importance of process in ensuring a robust strategy is in place for the acquisition and analysis of trial data in the face...
Clinical Research: Phase 1 - Phase 4
Setting a Real-World Strategy in an Evolving Clinical Research Environment
Presented byStacy Weil, Senior Vice President, Clinical Data Operations, Strategic Business Optimization & Nach Dave, RPh., MSc, Vice President, Development Strategy Related Resources Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm? Data Driven: How Electronic Patient-Reported Outcomes (ePROs) Provide a Vital Opportunity to Capture Key Data Beyond the COVID-19...
Data Management & Biostatistics
Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm?
In times of crisis, there is often value in taking a step back and reassessing some of the traditional ways of doing things. As the clinical research community tackles the issues COVID-19 has raised for ongoing and future studies, we at Premier Research are meeting the challenge of developing alternative paradigms and new ways to...