We’ve seen a shift in the way clinical trial data can be submitted as more companies have conformed to specifications such as CDISC, SDTM or ADaM specifications.
“With the impending approval of PDUFA V, which includes language around the requirement of ‘standardization of electronic drug application data’, it is very apparent that if we are not implementing standards in our submissions, it’s beyond time to start.” wrote Joanna Koft in her blog post titled ‘So many Standards, so little time’
She went on to write, “It’s very difficult to find individuals that are experts in the implementation of multiple standards. Many people understand just one or two of the models to an expert level.”
This difficulty in training and finding experts in statistical programming is a core reason companies are turning to statistical programming consultants like SimulStat to assist with their clinical trials. Pharamceutical and BioTech companies have the option to outsource or supplement their in-house biostatistical staff for specific projects, which helps ensure critical clinical trials are completed on-time with professional programming, validation and documentation.
“SimulStat has allowed us to fill in programming staff during peak work periods. They are available to work off-site or on-site. They have access to the kinds of programmers we need when we need them. They are even helping us put together a training program for contract and temporary
programming employees.” said a Manager of Biostatistics and Data Management about their experience outsourcing statistical programmers.