Data Management & Biostatistics

Data Management & Biostatistics

Path to Sophisticated Data Management

The modern pandemic has ushered the Biotech, Pharmaceutical, and Medical Device industry into an era where clinical trials require accelerated timelines on unprecedented levels. As such, modern clinical data management teams are responding to the need for intelligent analytical data review by leveraging technological advancements and advanced centralized data management experts. This powerful combination yields...

Data Management & Biostatistics

Premier Research Names Jennifer Nezzer Vice President of Biometrics

Morrisville, N.C., September 2, 2021 — Premier Research has appointed Jennifer Nezzer, M.S., as Vice President of Biometrics. Nezzer, an industry-recognized expert in biostatistics with more than 25 years of global clinical research experience, will head Premier’s integrated Biostatistics and Medical Writing operational departments. Premier Research is a leading provider of clinical research, product development,...

Clinical Research: Phase 1 - Phase 4

Clinical Researcher: Real-World Late-Phase Trials – How They’re Helping Sponsors Bridge the Gap from Drug Efficacy to Effectiveness

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...

Clinical Research: Phase 1 - Phase 4

International Clinical Trials: How Contingency Plans Became the New Normal

Over the last decade, there has been increasing interest in mobile health (mHealth) and wearables. The general population has been tracking their steps, checking their heart rates, and monitoring their sleep patterns. Meanwhile, the clinical trial industry has been exploring decentralized trials and remote monitoring options as a way of alleviating the travel burden that...

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: PremierOne 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 around a study that may be stalled due to lagging enrollment, regulatory challenges, or...

Data Management & Biostatistics

PremierOne Ecosystem – Delivering clarity amid the complexity

Fully Integrated Ecosystem Fuels Biotech Innovation The PremierOne 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 capture,...