June 11, 2014
Glen Burnie, MD– CSSi, the leader in patient recruitment solutions for the clinical research industry, recently announced the formation of the company’s LifeSciences division. This entity was created to complement our other service offerings by providing guidance and support for all phases of the product life cycle, from product concept and early planning to post approval compliance and surveillance.
CSSi LifeSciences provides innovative solutions which span the entire lifecycle of a new drug or device by reducing time to market, development costs, and resources. Their portfolio of service offerings includes Health Authority Interactions, Regulatory Consulting, FDA/EMEA Advisory Committee Support, Clinical and Site Planning Services, and Regulatory and Clinical Communications Services. Since 2005, the LifeSciences team members have worked on more than 150 new drugs, biologics, and devices, and have extensive “First in Class” and “First Indication” experience.
The LifeSciences team is being led by James Sergi, who has held various positions in academic nursing and cancer research, before co-founding and serving as CEO of a healthcare services and drug development company. His academic and medical experience includes Director and Administrator for the Department of Experimental Therapeutics at the Cleveland Clinic Cancer Center, Associate Professor of Medical-Surgical Nursing at the Case Western Reserve University Frances Payne Bolton School of Nursing, Lecturer for Oncology Nursing at the Cleveland State University College of Nursing, and Research Manager of Hematology and Medical Oncology at the Cleveland Veterans Administration Medical Center Research Division.
“The regulatory industry is constantly changing and evolving which presents continued challenges to pharmaceutical companies who are tasked with bringing new drugs to market quickly while maintaining cost efficiency,” states Chris Trizna, President of CSSi. “CSSi is thrilled to bring Jim Sergi on board as President to lead this new division. His extensive experience in the regulatory industry will allow us to increase our global operation capabilities as pharmaceutical companies are relying more on outsourcing regulatory needs to market their new medicines.”
“CSSi LifeSciences will allow clients to be more effective and knowledgeable when dealing with the complex arena of regulatory operations and affairs. I am very excited to join CSSi and help them broaden their service offerings to include regulatory information solutions,” commented James Sergi, newly appointed President of CSSi LifeSciences division. “With offices in Baltimore, San Francisco and London, CSSi LifeSciences is positioned to drive successful outcomes for pharmaceutical companies of all sizes and specialties.”