Media, PA, April 02, 2011 --(PR.com
)-- Compliance Implementation Services (CIS), a pharmaceutical compliance consulting firm, today announced that it is solidifying its clinical compliance expertise and service offerings amidst a more highly regulated pharma landscape with respective hires of three new regulatory specialists.
With the increase in global clinical trials, including an expanded FDA foreign presence, and the demand for more outsourced services, both sponsors and contract organizations are facing more frequent and rigorous GCP inspections.
“Companies need to take proactive measures to mitigate the overall compliance risk to their organization,” said Annette Horner, CIS senior director of global clinical compliance. “They need a partner that understands regulations from a global perspective and can provide necessary guidance. The addition of new team members, each of whom has strong clinical and regulatory experience, will allow CIS to better serve clients who are feeling the pressures of this increased compliance scrutiny.”
Joining CIS are Diane Dellaratta, senior clinical compliance specialist and project manager; Billy Grimme, senior clinical compliance specialist and project manager and Karen Chaney, clinical compliance specialist.
Diane Dellaratta joins CIS from Pfizer (formerly Wyeth) where she served as a global laboratory and vendor quality monitor specialist. She has strong industry experience in clinical vendor management, clinical vendor auditing, research and development, and clinical laboratory management, having also worked for GlaxoSmithKline, Quest Diagnostics, and Merck & Co. Diane is a member of the American Society for Microbiology, as well as the Biotech and Pharma Professionals Network. She holds a Bachelors of Science degree in microbiology from Pennsylvania State University in University Park, Pennsylvania.
Billy Grimme joins CIS from PPD Inc., where he served as a lead clinical research associate across various clinical trials. He has solid clinical and regulatory expertise through extensive global clinical site monitoring, vendor management, and investigator site qualifications/audits. Billy is skilled in standard operating procedure review, gap analysis, and global process harmonization/improvement consulting engagements. He holds a Bachelor of Science degree in biological sciences from North Carolina State University in Raleigh, North Carolina.
Karen Chaney joins CIS from PPD Inc., where she served as clinical administration manager across various clinical trials. She has clinical and regulatory expertise in process/training development and implementation as well as vendor management. Karen is skilled in standard operating procedure review, gap analysis, and process harmonization/improvement. She holds a Bachelor of Arts degree in psychology from North Carolina State University in Raleigh, North Carolina.
Compliance Implementation Services (CIS) is a consulting firm specializing in compliance strategies for the pharmaceutical industry, from Global Clinical Research and Development, through Manufacturing, U.S. Commercial Compliance, and Government Programs. Founded in 2004, CIS provides its clients with a deep understanding of industry laws and regulations, innovative and practical applications, and custom solutions to establish a “Culture of Compliance” that is both meaningful and sustainable.
CIS experts identify, assess and prioritize an organization’s exposure to compliance risks, subsequently developing and implementing risk evaluation and mitigation techniques to ensure adherence to legal and regulatory requirements.