Tag: services

Data Management & Biostatistics

Discover the Vital Intersection Where Data Ops Meets Quality Assurance at SCDM

Join us at SCDM 2018 for a session chaired by Sara Doolittle, Associate Director of Data Operations While quality assurance and data operations are generally considered separate entities in clinical drug research, in theory and in practice they are intertwined at multiple levels involving numerous stakeholders. Sara Doolittle, Premier Research’s Associate Director of Data Operations,...

Clinical Research: Phase 1 - Phase 4

5 Must-Dos To Build Trust Between an Early-Stage Biotech and CRO

Most early-stage biotechnology companies have limited resources and manpower. As a result, early-stage biotechs conducting randomized clinical trial research often need a CRO’s help to deliver the quality data required to make their ideas and theories achieve practical purpose. In addition, engaging a CRO with a depth of strategic expertise early in the planning process...

Clinical Research: Phase 1 - Phase 4

Study Start-Up: Why You Really Need to Get This Right

You get one chance to initiate a clinical trial. Botch the start-up and you’ll expend great effort correcting course and playing catch-up. The waste of money and time — commodities that are chronically scarce among the biotech and specialty pharma companies that comprise most of our customer base — can be devastating. That’s why we...

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

Informed Strategy Key to Drug Development Innovation, Premier Research Says in Naming Regulatory Chief

DURHAM, N.C., June 27, 2016 — Small biotechnology companies taking new biopharmaceutical products from benchtop to bedside need an informed regulatory strategy and a close working knowledge of the Food and Drug Administration and other regulatory agencies. So when it sought a new head of regulatory affairs, clinical development service provider Premier Research found its ideal...

Medical and Regulatory Affairs

Europe’s New Trial Regulations: Quality VP to Address 2016 West and Wales Forum

DURHAM, N.C., April 05, 2016 – New European Union standards governing clinical research have significant implications for future drug trials. Nicky Dodsworth, Vice President, Quality Assurance, Risk & Compliance at Premier Research, will discuss these changes at the 2016 West and Wales Regional Forum on Innovation and Risk, April 21 in Milton Park, Oxfordshire, U.K. In...