Data Management & Biostatistics

Clinical Research: Phase 1 - Phase 4

TrialSite News: Going Virtual: How to Implement mHealth and Remote Monitoring in Your Clinical Trials

In the year since COVID-19 brought all normal activity to a halt, clinical trial professionals around the world have been forced to re-examine their strategies. What happens when neither patients nor clinical research associates can visit trial sites? How can data collection and data monitoring occur — and critically, how can researchers deliver clean, concise...

Clinical Research: Phase 1 - Phase 4

Key Changes in the Revised EMA Guidance on Clinical Trials During COVID

In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent...

Clinical Research: Phase 1 - Phase 4

Rethinking Data Quality Best Practices in the Era of Decentralized Clinical Trials

Pandemic-related disruptions have accelerated much-needed change in clinical operations, but this change has been accompanied by questions about data collection and data quality. In a recent survey commissioned by Oracle Health Sciences, more than 75 percent of industry respondents indicated that limitations in patients’ ability to attend on-site visits sped up their adoption of decentralized...

Data Management & Biostatistics

Premier Research Vice President, Statistical Consulting, Recognized by AMSTAT for Black History Month

DURHAM, N.C., February 1, 2021 — Premier Research, the clinical research company that delivers outcome-focused insights which support sponsors in developing life-changing therapies, announced today that Abie Ekangaki, Ph.D., Vice President, Statistical Consulting, has been recognized by the American Statistical Association (AMSTAT) in celebration of Black History Month. Dr. Ekangaki is one of ten Black...

Data Management & Biostatistics

Explainer Video: Premier One Ecosystem Hybrid Case Study

Today’s technology enables us to seamlessly integrate data for every stage of a clinical trial, from lab results to mobile health apps, patient-reported data, and much more. These new sources of data allow us to better interpret, predict, and quickly turn aound a study that may be stalled due to lagging enrollment, regulatory challenges, or...

Data Management & Biostatistics

Premier One Ecosystem – Delivering clarity amid the complexity

Fully Integrated Ecosystem Fuels Biotech Innovation The Premier One Ecosystem aggregates all the data captured within our ePremier environment. The ecosystem also represents Premier Research’s processes for data analysis related to administrative and financial data, study management data, and patient data. Among systems contributing to the ecosystem are risk monitoring, clinical trial management, electronic data...

Clinical Research: Phase 1 - Phase 4

mHealth and Remote Clinical Trial Strategies to Include in Your next Study

What happens when patients and clinical research associates alike can’t—or won’t—go to your clinical trial sites? It’s time for a new plan. In the months since the novel coronavirus brought all normal activity to a halt, clinical trials worldwide have been forced to re-examine their strategies and reconsider their approach to data collection, data monitoring,...

Consulting

Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development

Professionals focused on drug development are charged with making the most of their resources, maximizing the value of their work, and bringing effective products to market as quickly as they can without compromising quality or safety. It is a long list of responsibilities, and development professionals struggle to balance all of them. Sameena Sharif, senior...

Consulting

Real-World Data and the FDA: How to Make Sure Your Data Counts

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...

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...