Healthy Skepticism Library item: 14538

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Publication type: news

According to Research by Cutting Edge Information, Only 59% of Pharma Companies Own Dedicated Compliance Departments
Fierce Biotech 2008 Oct 28
http://www.fiercebiotech.com/press-releases/according-research-cutting-edge-information-only-59-pharma-companies-own-dedicated-co

Full text:

A new study by business intelligence firm Cutting Edge Information finds that only 59% of pharmaceutical companies currently own dedicated departments for compliance. The study, “Monitoring and Ensuring Pharmaceutical Compliance,” highlights the growing need for creating a dedicated compliance department.

With only 59% of pharma maintaining a dedicated department for compliance, there are still a healthy percentage of companies who remain vulnerable to unforeseen regulatory changes. Building a strong compliance management team will give the staff the necessary power to effectively manage their internal clients’ changing needs.

Maintaining a dedicated compliance department also signals to outside agencies that the company takes regulation seriously. Giving an outward appearance of a company willing to police itself goes a long way in the court of public opinion. The damage done by a compliance misstep can take a long time to recover from — both legally and in the eyes of company stakeholders.

“New laws and regulations affecting pharma companies’ abilities to do business seem to be coming out more and more often,” says David Richardson, senior analyst for Cutting Edge Information and lead author of the study. “There is no doubt in my mind that companies with dedicated compliance departments are better prepared to handle and adapt to these changes.”

The 104-page report makes its case with 300+ metrics and numerous insights and industry best practices for managing these three aspects of the regulatory landscape:

— Structure, Headcounts and Investment — Provides up-to-date structuring strategies, headcounts and investments of top compliance groups

— Monitoring and Ensuring Compliance — Details companies’ strategies regarding monitoring, training, testing, documentation, firewalls, and much more

— Activities and Challenges — Examines the focus and reach of top compliance functions as well as the impact and reactions companies have made to recent regulations. Survey respondents also rate the challenges facing compliance efforts forward.

Key metrics and topic areas in the new pharmaceutical report include:
— Compliance structures
— Compliance training and testing methods
— Firewalls
— Corporate Integrity Agreements
— Standard Operating Procedures
— Risk Assessment
— Audits
— Live monitoring
— Functions trained by compliance departments
— Benefits of documentation
— Impact of regulations on companies’ practices

To download a free, online brochure of this report, visit http://www.cuttingedgeinfo.com/pharmacompliancemanagement/PH113_Download.asp#body.