We often wonder why the regulatory rules are so stringent for pharmaceuticals. At the end of the day the primary goal is to protect the patient. Today, I read an article that defied belief. A contract research and development organization was caught modifying documents and samples! There are not only implications for patients who may receive potentially unsafe products but those pharma and biotech companies that have invested may have to re-file, even fail or enter class action law suits in extreme cases. For their financial investors this could send share prices through the floor.
To quote the article “Specifically, in at least 1,900 instances between April 2005 and June 2009, laboratory technicians identified as conducting certain studies were not actually present at [Company Not to be Named by Accelrys] facilities at that time, the FDA said in its May report”
I can't help but wonder if the scientists were still using paper lab notebooks. After all, paper has always been the very foundation of the forger's trade. Moving to an electronic environment documenting samples, experiment ownership and providing data traceability along with not just electronic signatures, but full electronic audit trails, makes falsifying information that much harder.
In the land of paper processes and paper documents anyone with pen and paper can make some subtle changes or create documents and samples at a later date with ease. With an ELN this becomes near impossible to do and importantly, hide, unless the whole company is in on the deal. Falsifying data within an ELN is near impossible. You need to be a scientist, a database wizard and be an expert in IT systems that have been designed to protect billions of dollars from fraudulent activities, for instance, in financial institutions.
I see news like this not only accelerating the use of ELNs, but also resulting in contracting organizations mandating 3rd parties to use more robust and electronic methods to document their day-to-day experiments, instead of a paper based process. In addition, I see that contract research and development companies can gain competitive advantage by demonstrating that they have electronic systems that protect their partners from fraudulent activities that can have massive financial and liability implications.