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...

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...

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...

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...

Clinical Research: Phase 1 - Phase 4

Are We Trading Speed for Innovation in Approving New Drugs?

DURHAM, N.C., February 16, 2018 — Are expedited approvals of new drugs occurring at the expense of innovation? Nach Davé, Vice President of Global Regulatory Affairs at Premier Research, will explore the subject at Outsourcing in Clinical Trials West Coast 2018, February 21 in Burlingame, California. In his presentation, Faster Approvals but Less Innovation: Trend...

The Outlook for Orphan Drug Research: A Live Webinar

DURHAM, N.C., DECEMBER 5, 2017 — The outlook for orphan drug research is more promising than ever, with regulators providing a progressive development platform and government reforms putting new emphasis on the need to treat rare diseases. Premier Research will examine the outlook for biotech and pharma companies at a live webinar on Tuesday, December...

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...

Quality

Quality Assurance VP Speaking at Life Sciences Webcast July 20

DURHAM, N.C., June 29, 2017 — Premier Research’s head of quality assurance will speak on life sciences supplier certification during a webcast hosted by The Knowledge Group. The event takes place Thursday, July 20, from 3 p.m. to 5 p.m. Eastern. The Life Sciences’ Supplier and Contractor Qualification and Control Framework Explored will address challenges...

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...

Consulting

Risk-Based Decisions Topic of Panel Talk at Quality Consortium

DURHAM, N.C., June 7, 2017 — Premier Research’s leading quality expert will host a panel discussion on risk-based decision-making at the Avoca Quality Consortium’s 2017 summit in Dublin. The discussion, starting at 2:15 p.m. June 8, will address needs in transforming human capital management and improving risk mitigation in clinical trial execution. It’s an ideal...