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Tag: clinical trials

Clinical Research: Phase 1 - Phase 4

Premier Insight 277: Optimizing Enrollment for a Phase 3 Clinical Trial During a Global Pandemic

Background A biopharmaceutical company focused on delivering innovative products for women’s health chose us to manage their Phase 3 clinical trial evaluating an investigational, thermosetting, bioadhesive hydrogel for bacterial vaginosis (BV). We leveraged our expertise in study design and execution along with our extensive network of OB/GYNs to deliver a successful clinical study ahead of...

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Patient and Stakeholder Engagement

Premier Voices #8: Engaging Patients in Clinical Trials w/ Alan Thomas

Clinical research certainly has evolved over the past three decades. There are more trials crossing a broader spectrum of indications, and advances in study design and execution have dramatically changed the way drugs and medical devices are evaluated and sold. But perhaps no change has been more significant than the growth in engagement on the...

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Clinical Research: Phase 1 - Phase 4

Expert to Discuss Trial Cost Forecasting at Industry Financial Summit

DURHAM, N.C., March 30, 2018 — Predicting the cost of clinical trials is a complex task, and more CROs are providing grant forecasting as a service to produce more accurate projections and give customers greater visibility. A grant forecasting expert from Premier Research will discuss new approaches to predicting trial costs in April at the...

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Clinical Research: Phase 1 - Phase 4

Why Forecasting Trial Costs Is So Hard (and Getting Harder)

Forecasting the cost of clinical drug and medical device trials has never been easy, and as trials become more complex, estimating (and re-estimating) these costs becomes even more challenging. Lack of accurate forecasts has serious schedule and cost implications. By impeding effective cash management, inaccurate projections can lead to disruptions and delays that cost sponsors...

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Consulting

Finding Endpoints in Medical Device Trials: Attend Our Webinar

DURHAM, N.C., September 5, 2017 — Defining efficacy and safety endpoints that are scientifically measurable, objective, and valid is a critical challenge for developers of medical devices. At a live webinar on Tuesday, September 12 (11am EDT / 4pm BST / 5pm CEST), Premier Research will examine how clinical endpoint committees play an ever-larger role...

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Data Management & Biostatistics

Quality Expert to Discuss Data Integrity at DIA Annual Meeting

DURHAM, N.C., June 19, 2017 — Data integrity has been a prime focus of pharmaceutical regulators for two decades now, but the focus is sharpening markedly with issuance of new guidance from multiple regulatory authorities. Sherri Hubby, who leads quality assurance, risk, and compliance at Premier Research, will address this trend and its implications at...

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Consulting

Experts to Discuss Pediatric Medicines, Wearables at EuroMeeting 2017

DURHAM, N.C., March 27, 2017 — Two Premier Research drug development experts will speak at the Drug Information Association’s EuroMeeting 2017, March 29-31 in Glasgow: Dr. Thomas Laage, Senior Medical Director, will take part in a session on optimizing development of pediatric medicines on Thursday, March 30, from 11 a.m. to 12:30 p.m. Dr. Laage...

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Quality

The Trends Reshaping Medical Device Trials: Attend Our Webinar on Nov. 2

DURHAM, N.C., OCTOBER 27, 2016 — Medical device and diagnostic companies are conducting more clinical trials than ever, a trend that’s giving rise to new procedures and best practices for studies that differ in many ways from pharmaceutical trials. Register for this webinar focused on the evolution of device clinical research on Wednesday, November 2....

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Consulting

Early-Stage Considerations for Maximizing Success in Initial Oncology Clinical Trials

There’s a lot to consider when investigating a novel and targeted oncology compound, and decisions you make early on can have profound and lasting implications. In this webinar, Premier Research shows how making sound decisions from the outset can improve your odds of long-term success. Oncology experts, Paul Hallenbeck and Luke Gill, Executive Directors for...

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