Posted by: Ethan Smith in: ● July 26, 2011
It’s no secret that Life Sciences is one of the most highly regulated industries with ever-increasing obligations and scrutiny. As these requirements increase it is essential that you are prepared for changes that you can expect will continue to come. Life Sciences companies should build into their operational structure a plan for continuous change and [...]
Posted by: Derek Weeks in: ● July 19, 2011
Regulatory Document Submission is one of the most time consuming, yet critical steps pharmaceutical, biotechnology and medical device companies must take to meet government requirements, ensure patient safety, and get a new product introduced to the market. While it is essential to the health of a pharmaceutical company to get its submissions issued efficiently, many [...]
Posted by: Derek Weeks in: ● April 1, 2011
A week or so ago Metastorm presented a webinar on how to manage change in different industries. The webinar explained how industry-specific capability models can accelerate the value of an organization’s transformation efforts. So what industries are most in need of a formal business transformation framework and platform? When polled, respondents clearly emerged as having an immediate need [...]
Posted by: Derek Weeks in: ● February 2, 2011
Today, Metastorm announced that Forest Laboratories has selected Metastorm’s enterprise software suite for its business process improvement initiatives. Forest has selected several business processes for analysis and automation – including a strategic initiative to model, analyze and automate business processes related to Aggregate Spend Management and compliance with the U.S. Federal Physician Payments Sunshine Act. [...]
Posted by: Ethan Smith in: ● January 25, 2011
As 2011 gets into full swing, I can’t help but think about the impending federal regulations forcing pharmaceutical companies to document, track and report payments to physician and physician owned entities, set to begin at the end of the year. In its annual Predicts 2011 series, Gartner recently published a list of predictions for the [...]
Posted by: Derek Weeks in: ● December 20, 2010
Last September, as you probably remember, Allergan reached a $600M settlement regarding its off label promotion of BOTOX—which sparked some interesting dialogue about leveraging business process management software to solve new compliance requirements within the pharmaceutical industry. Starting January 2012, U.S. federal government has required that all pharmaceutical companies document, track and report a wide [...]