Data Management & Biostatistics

Data Management & Biostatistics

Premier Insight 238: Back On Track: Data Rescue On Pediatric Rare Disease Trial

  Imagine rebuilding the engine in an ambulance carrying a critically ill patient to the hospital. Got it? Then you have a pretty good idea what it took to put this pediatric rare disease trial back on track. A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was...

Data Management & Biostatistics

ASA Biopharmaceutical Workshop to Explore Study of Chronic Pain

DURHAM, N.C., SEPTEMBER 29, 2016 — Point-in-time “landmark” analysis, the standard in most chronic pain studies, may not be appropriate for evaluating single-dose drugs. Instead, an analysis strategy similar to that used in acute-pain research may be more effective, Premier Research’s top biostatistics expert will assert in a poster presentation at the American Statistical Association’s...

Clinical Research: Phase 1 - Phase 4

Working with a CRO

The challenges of greater regulatory scrutiny, complex logistics, downward cost pressure and increasingly rigorous data requirements are just a few of the reasons biotech and pharmaceutical companies look to outsource clinical trials. In a dynamic healthcare and regulatory environment, outsourcing increases flexibility by streamlining clinical trial management and enabling sponsors to concentrate their resources on...

Consulting

Premier Insight 268: When Other CROs Said No, We Said Yes – to the Nearly Impossible

The client asked the nearly impossible — a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it. So we...

Consulting

Premier Insight 243: The Question Was a Real Puzzle – and the Answer Changed Everything

Things were complicated enough to start. The customer, conducting a Phase 2/3 dose-finding/pivotal study for an adult growth hormone drug, changed its protocol midstream in response to regulatory feedback and was rethinking other aspects of the trial, adding to its complexity. For weeks, the sponsor’s requirements changed almost daily, severely testing an incumbent lab vendor...

Data Management & Biostatistics

Premier Insight 240: Getting Every Detail Right – With No Time to Think About How

Our customer was racing to beat a competitor to registration. One critical part of the timeline: Last patient out to database lock in two weeks. In sister studies that involved 800 patients at 90 sites. And several primary investigators who were heading off on vacation just when we needed their sign-offs on the data. We...

Data Management & Biostatistics

The Ethical Challenges of Adaptive Design: Join a Premier Research Webinar Nov. 19

PHILADELPHIA, November 10, 2015 — What happens when a widely recognized advance in clinical trial design poses ethical questions? Find out Thursday, Nov. 19, at a complimentary Premier Research webinar, Ethical Considerations in Adaptive Design Clinical Trials. The hour-long event, starting at 11 a.m. EST / 4 p.m. BST / 5 p.m. CET, will examine particular...

Data Management & Biostatistics

A Smarter Tomorrow: How CROs Can Produce Better, More Objective Data

PHILADELPHIA, October 21, 2015 — Clinical research must produce consistent, reproducible results to be of real value. But too often, underlying decisions are based on opinions and not on well-defined, objective criteria, complicating things and making objectivity impossible. Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will address this issue at the...

Data Management & Biostatistics

Premier Research Achieves Medidata Rave Accreditation for Clinical Trial Processes

Premier Research has been accredited to the Medidata Rave system for data capture and clinical trial management. The achievement certifies the company to build Medidata Rave databases and include this widely adopted electronic data capture and clinical data management system in its repertoire of offerings to improve clinical trial processes and increase productivity.

Data Management & Biostatistics

Premier Research Announces Adoption of eTMF System

Premier Research announced today that it will use a new electronic Trial Master File (eTMF) system on all Clinical Development Services Studies. Trial Interactive has been tapped to provide the supporting platform. The adoption of eTMF is the company’s latest investment in its 2012-2013 technology RoadMap focused on three key areas ...