Tag: data management

COVID-19

PREMIER VOICES #11: Statistical Considerations in the Wake of COVID-19

COVID-19 has dramatically changed the way we conduct clinical trials and left many sponsors without answers when it comes to the future of their studies. Recognizing the issues is one thing, but figuring out where we go from here demands a new way of looking at some common challenges. In this episode, Premier Research’s Shari...

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,...

Data Management & Biostatistics

Beyond Meltdown and Spectre: Our Take on IT Security

No doubt you’ve heard much about Meltdown and Spectre, major security defects in the microprocessors that underpin nearly all of the world’s computers. Hackers, the world learned in early January, can exploit these defects to steal the entire memory contents of PCs, mobile devices, and the servers that make up cloud computing networks. That puts...

Data Management & Biostatistics

Premier Insight 244: Data Management: A Growing Challenge, Made Easier

Every day, the world creates and stores 2.5 quintillion bytes of data. If you really must know, that’s 2,500,000,000,000,000,000 bytes. We’re piling it up faster than ever, too — so fast that 90 percent of the data that exists today was created in the past two years. Moving and sharing all that information is a...

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 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.