What’s missing could be a system that pulls all of your different R&D processes into a single product development platform. Such an integrated system can better monitor the hundreds of drug candidates in your pipeline, more quickly advancing winners and eliminating losers.
Implementation won’t be easy. Plan to work closely with a consultancy that understands your scattered lab systems, underlying processes and labyrinthine regulatory requirements. One particular area of focus will be the preclinical development environment, where specialized laboratory information and scientific data management systems will pave the way for the top-level enterprise application. Once in place, this Web-based process and information management software suite will give the staff analytical tools that will provide a snapshot of every compound in development, drawing on such data as lab notes, regulatory documents and pharmacological results.
The improved quality and speed of decisions in the preclinical stage is crucial, says Shoibal Datta, director of life science at Tribiosys Inc., since much of the investment in a new drug is triggered by its advance to high-profile human clinical trials and FDA approval. “Obviously, the sooner you are able to make that go or no-go decision on a candidate, the better,” Datta says, “even if it means just one day.”