Data Management & Biostatistics

Data Management & Biostatistics

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Clinical Research: Phase 1 - Phase 4

Leadership Development and Becoming a More Effective Change-maker

They say that great leaders aren’t born, but grow into their positions through sweat and tears. No matter what stage in life, industry, or phase of your career you’re at, it is important to continuously strengthen your skills, and this ongoing development is one of the key values we look to foster in our team...

Data Management & Biostatistics

3 Key Takeaways on Choosing the Right Committee for Medical Device Trials

As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency...

Consulting

Decoding the Distinction: DMCs, CECs, and Their Role in Medical Device Research

Data monitoring committees and clinical endpoint committees can provide independent, expert review of study data and opinions to standardize outcomes and optimize data quality to help sponsors meet complex trial monitoring requirements.

Clinical Research: Phase 1 - Phase 4

DMC? CEC? Your Guide to Translating Clinical Trial Shorthand

We were reviewing a study protocol for a maker of medical devices, and there was one provision that just didn’t make sense. The sponsor specified a need for regular data monitoring committee meetings, but we didn’t see the need and couldn’t justify the effort. It was a short study involving few sites. In all likelihood,...

Data Management & Biostatistics

Decoding The Distinction: DMCs, CECs, And Their Role In Medical Device Research [Webinar]

As global, multi-center medical device studies become increasingly common, trial monitoring is growing more complex. Regulators require that sponsors perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor agreements, investigational plans, and the requirements set forth by the study’s institutional review board. Additionally, sponsors are responsible for selecting qualified monitors to...

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

Demystifying the Differences Between DMCs and CECs

In a clinical trial landscape where global, multi-center studies have become increasingly common, trial monitoring has become more complex. Regulations require that sponsors of medical device studies perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor agreements, the investigational plan and the requirements set forth in the Investigational Review Board (IRB)...

Data Management & Biostatistics

ICH GCP Update: Sponsor Control of Clinical Trial Data

Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data. The recent update of...

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...