As we become more interconnected via social media, globalization, and improved technology, the speed at which pharmaceutical and biotechnology companies’ practices are converging is ever increasing. While there was a time when programming standards and reporting tools were home grown within each company, the industry is now moving toward a single set of global standards dictating everything from data collection to electronic filing submissions.
How can statistical programmers keep up in this ever changing, globalized world?
Pharmaceutical Users Software Interchange (PhUSE) has set up forum to help statistical programmers build and archive global standards relating to collection, analysis, and reporting of data from clinical trials. For the past year, PhUSE has been working with regulatory agencies such as the FDA to set up the PhUSE Wiki, a platform containing information and resources relating to global standards and invites collaboration and dynamic dialogue among professionals from various industries and regulatory agencies.
Currently the PhUSE Wiki has content related to 3 broad topics: derivation standards, good programming practice, and output templates. Viewing access to the PhUSE Wiki is free of charge and does not require a membership. To post content and comments however, you must be a registered member. As with any collaborative project, content becomes richer with greater and more diverse input. Time will tell if this site can develop into the go-to forum for data managers, statisticians, and statistical programmers in the pharmaceutical industry to keep abreast of global standards relating to their daily work.
I encourage you to take a look at this site and see if it can be of use to you. http://www.phuse.eu/Wiki.aspx