The Highest Standards
Any CRO or FSP provider can supply resources to support your Biostatistical and SAS Programming requirements but only a select few will keep their commitment for excellence by providing highly experienced (>10 years) biostatistical and SAS programming experts. Our strong foundation allows DataCeutics to distribute expertise to all channels of our Center of Excellence. Take a look below at what you receive being an important customer of our company.
We don't just scratch the surface. We have deep roots in CDISC since 2005.
Our CDISC leader has 25 years experience as a SAS Programmer and 13 years in CDISC- since it's inception. Everything from how important standardization is needed to what is done when this requirement through to reporting. Our leader provides continuous improvement in CDISC by keeping our resources trained in CDISC standards.Throughout the DataCeutics keeps current on the latest requirements for SDTM, ADaM, Define.xml and the Reviewers Guide.
Statistical Computing Environment (SCE)
Processes, Procedures, People and Tools are the focus of SCE assessments.
The SOPs may be similar from company to company however, it is the unique programs and activities of the sponsor that can make the assessments unique. A combination of DataCeutics 25 years in servicing the pharmaceutical and biotech industry along with our strong commitment to process, procedures and methodologies provides for our ability to assess your compliance with 21 CFR Part II.
CR Toolkit™ & SAS Macro development
We claim a 50% reduction in lines of code.
You don't have to imagine a faster, more consistent, and tested set of code that produces reports for FDA submission. We've done it and can offer you a better way too. We've got a ready to go format for you or if you provide a sample of your report format today, we can replicate with macros that
We are top performers in the industry. Our SAS programmers are seasoned, self starters with 10 years or more of programming experience.
Statistical programming and even more specifically, SAS programming, is an important set of skills needed by the pharmaceutical and biotech industry as part of the FDA's requirements. The programmers are providing a very important service which comes into play during the last mile to submission. Do you really want to risk your submission working with inexperienced programmers?
Registries provide the basis for sponsors' research.
Our SAS Programmers work on large datasets and with methods for presenting data in SAS. In close collaboration and dialogue with the sponsors' staff, the SAS programmer will participate in the drafting of scientific papers and publications within clinical epidemiology including programming and analyzing clinical indicators that show the information pertaining to the product.
For the Biostatistician, the Statistical Analysis Plan (SAP) defines and delineates all statistical methods and analysis outputs in the Clinical Study Report.
The work of the biostatisticians is focused on sample size and power estimations, rules for handling missing data, definitions of populations, interim statistical analysis, methods for analysis of efficacy endponts.
The information gained from the results of ongoing PK analysis during a clinical trial is invaluable for both monitorings and for compiling FDA submission reports on both the safety and efficacy of very many experimental drugs.
Our programmers sort out data from various sources, convert them into standard format, gather all variables, organize them into specified structure, derive further variables and handle outliers/missingvalues/error data based on specific requirements. The entire process is normally very time consuming and resource demanding therefore we ensure we provide programmers that are very persistent and knowledgeable.