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 here.
Cutting Edge