EmpiriStat provides a wide range of services throughout every project and clinical trial phase.
EmpiriStat has the skills, knowledge and experience to perform DSMB services professionally and effectively.
EmpiriStat has the expertise and capability to succeed at collaborating and managing overall projects and clinical trials beyond biostatistical services.
Effective and well-executed data management is a vital part of any project or clinical trial, and EmpiriStat’s guidance of clinical data management ensure the quality of your results.
EmpiriStat's strength is our knowledge of every phase in your project, and the ability to understand and contribute to your program's objectives. We collaborate with you at every stage—from proposal development and grant writing to protocol development and statistical analysis planning...through programming and interpretation...to final validation and reporting.
Equally important are the practices and methodologies we apply throughout the entire timeline: rigorous quality control, thorough documentation, transparency, and regulatory compliance. EmpiriStat effectively becomes a part of your team—as well as your thought process. We proactively suggest improvements, offer guidance, and provide accurate, timely, and effective service.
We tailor our timelines to your timelines with the flexibility that is needed in clinical trials. You will not find the standard excuses from other providers at EmpiriStat, we deliver topline TFLs in a matter of days after database lock NOT weeks. We push you to think ahead and prepare, and with that collaboration you get reportable results for Executive level decision making.
But hey, who is counting (we are!). We handle data, and lots of it with the quality and precision you need in every clinical trial.
We are different and we can tell you how, but it is so much easier to show you. You get a focused "A – team" every time, and we never switch out our team members once they are designated for your project. We work hard, but we do like to have fun too.
A US biotech company prepared their NDA and wanted an Independent Biostatistical review of all data and Statistical requirements, including the CDSIC coding performed by the CRO, prior to submission to the FDA in order to prevent a Technical Rejection.
A pharmaceutical company was only months away from filing their NA with the FDA. They did not have an in-house Biostatistics/Statistical Programming group for review and writing of the ISS SAP and to conduct validation programming for their program. None of the studies were CDISC coded.
There is a reason why so many global companies choose EmpiriStat as a Biostatistical/Data partner. Our offerings are not only expansive, but specifically personalized to your needs. Find out why we are the right fit for you.