Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions. Listening to patients living with a condition, we can proactively address potential flaws in clinical...
In a multilateral paradigm shift, sponsors, payers, regulators, physicians, and patients are increasingly recognizing the value of real-world late-phase (RWLP) trials. The increasing use of real-world data (RWD) and real-world evidence (RWE) to support clinical development has been informed by recent regulatory guidance and accelerated by the global COVID-19 pandemic. Stakeholders across the spectrum are...
In drug development, there is always pressure to move quickly, and with today’s push to develop treatments and vaccines for COVID, those pressures are exacerbated. From sponsors and investors to investigators and regulators, everyone is trying to balance the dual needs for speed and safety. The places where they find success are likely to change...
Stacy Weil, Vice President, Clinical Data Operations, Strategic Business Optimization, and Kristi Miller, Ph.D., Vice President, Regulatory Affairs, address the following: Expanded patient enrollment options when using RWDNew strategies for collecting and monitoring patient dataRecent regulatory reforms concerning acceptance of RWDCase studies illustrating the use of RWD for regulatory purposes What’s challenging you today? Fill...
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...
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...
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,...
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...
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...
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...