Innovative technology and metrics plays key role in allowing FDA Advisory Committees to make informed decisions regarding control of prescription narcotics.
Earlier this month, Polaris supported an important two-day FDA Advisory Committee hearing to review Risk Evaluation and Mitigation Strategy (REMS) involving opioid use and physician training, providing metrics and data outlining achievements and milestones by pharmaceutical companies over the past 3 years.
The Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) convened to review the effectiveness of the REMS and discuss if it should be modified in response to ongoing concerns regarding trends in the abuse of opioids.
Polaris supports the process and provides the technology enabling the REMS group to train the 160,000 HCPs targeted for education by the third year of the REMS program. To provide this support, Polaris leverages its Request Management System (RMS), managing submissions, approvals and payments, in addition to compiling metrics and data, an integral element of the company’s Business Process Outsourcing (BPO) services.
Oversight and legislation regarding opioids is a hot topic currently with plans to assemble several opioid bills into a single measure being introduced in the House of Representatives, and President Obama proposing $1.1 billion dollars in funding to fight opioid abuse.
Large and small pharmaceutical firms have come to rely on Polaris’ Business Process Outsourcing (BPO) to deliver a cost-effective, end-to-end solution that efficiently manages business processes including grants request processing, payment processing, HCP/O background screening, KOL evaluation, disclosure and transparency reporting, HCP dispute resolution and Compliance office outsourcing.
“New challenges arise daily for companies working in the life science space and Polaris is uniquely positioned to help these companies be compliant, both locally and globally,” said Andy Bender, Founder and President of Polaris. “By providing pharmaceutical companies with innovative solutions for managing compliance processes, Polaris continues to stay at the forefront of the rapidly evolving life science compliance landscape,” Bender stated.
Polaris is the global authority on life science compliance, delivering innovative, expert consulting and comprehensive, best-in-class software and technology solutions, compliance management systems and business process outsourcing to the world’s most recognized pharmaceutical, biotech and medical device companies. Learn more at www.polarismanagement.com.