Compliance Leadership Team

Celine M. Clive, President, has more than 30 years of experience in diverse areas of the drug development process, including positions in pharmaceutical companies and CROs. She has worked with many clients to develop customized SOPs for their companies and institutions. She has developed and delivered orientation and training programs on a wide variety of topics. She’s the author of a reference book entitled “Handbook of SOPs for Good Clinical Practices.”  In addition, Ms. Clive performs GCP quality assurance audits for sponsors, CROs, study site personnel, and IRBs. She was an alternate member of The Copernicus Group IRB. Ms. Clive is the former President of North Carolina Regulatory Affairs Forum and is a member of ACRP, DIA, and other professional societies. Ms. Clive has a BS degree in Biology from Wilson College in Chambersburg, PA and an MBA from Meredith College in Raleigh, NC.

Claude B. "Ty" Tyson, Chief Information Officer, has over 38 years of experience in electronics and computer system design, sales, marketing, and IT management. Early in his career, designing calculators and computers at Texas Instruments, Ty purchased one of the original IBM PCs that hit the market in 1981, took it apart and learned it from top to bottom.  Fascinated with that machine and realizing its potential, he went on to found one of the first retail computer stores in the area to offer complete turnkey PC systems and support for business applications.

He has since designed and managed the installation of fully integrated server rooms in a number of enterprise sectors, to include big name clients such as Hilton Hotels.  As the IT industry has grown increasingly specialized, Ty has preferred to remain more of a generalist, resulting in his ability to install and manage enterprise solutions and to meet the increasing demands of computer system security.

Mr. Tyson has a BS in Electrical Engineering from NC State University and an AS in Aviation Electronics from Tarrant County College, along with industry certifications including Cisco, Microsoft, and Lotus.

Rosanne K. Sylvia-Heeter, Director of GMP Compliance, has over 30 years of GxP quality assurance experience with Active Pharmaceutical Ingredients (APIs), clinical research materials, and finished product.  During her career, she has developed global quality systems and prepared both domestic and international facilities for FDA Pre-approval Inspections (PAIs). Ms. Sylvia-Heeter has interacted with the FDA at both the Headquarters and District levels. She has held positions as Compliance Manager, Quality Assurance Manager, and Global Director at major research-based and generic pharmaceutical companies and consulting firms. Her memberships include ASQ and RAPS. Ms. Sylvia-Heeter holds a BS degree in Biology from Loyola University in Chicago. 

Lauren Kelley, CCRP, Associate Director of GCP Compliance, has worked for over 34 years in the pharmaceutical industry and specializes in GCP auditing. She has worked with sponsors, CROs, IRBs, and investigational sites to assure compliance with the GCP regulations and has trained many regulatory and clinical research professionals in GCP compliance. She has served as an instructor for the Western Institutional Review Board and DIA and is a frequent speaker at SoCRA and other professional meetings. Ms. Kelley has a BA degree from the University of North Carolina at Chapel Hill, a legal assistant certification from Meredith College in Raleigh, NC and she is a Certified Clinical Research Professional.

Karen S. Sargent, Senior GCP Auditor, has more than 30 years of experience in product development from the perspectives of the sponsor, investigative site, and the CRO. Ms. Sargent has extensive work experience in the pharmaceutical and medical device industries. Her work includes product safety and efficacy trials, pharmacoeconomic studies, and consumer behaviors and preferences. She has performed domestic and international audits of both pharmaceutical and medical device sponsors, clinical sites, IRBs, and vendor qualification assessments. In addition to FDA/ICH audits, Ms. Sargent has performed due diligence risk-assessment audits for acquisitions and mergers.

Ms. Sargent has published books, articles, and developed training courses for clinical investigators, clinical research coordinators, monitors, and quality auditors. She holds a BS degree in HealthcareManagement from Rutgers University and is a graduate of the Nuclear Medicine program of Duke University and the Radiologic Technology program of Morehead State University. She holds ARRT and NMTCB certifications in radiology technology and nuclear medicine respectively.

Karen L. Harrison, Project Manager, has over 35 years of experience in diverse areas of the drug development process, mainly in the pharmaceutical industry and over 10 years of experience in GCP. She has worked at the bench level testing antibiotics and in the development of radioimmunoassays. Her clinical experience started in the conduct of clinical trials for product line extensions. She was instrumental in consolidating domestic and international clinical trials for a major pharmaceutical company to obtain worldwide registrations.

Ms. Harrison’s extensive experience and knowledge of the pharmaceutical industry was invaluable when she took the position of a Product Liability Specialist and became a part of the legal litigation team. After this interesting era in her career, she joined the Clinical Quality Assurance area. While in the GCP area, she audited clinical sites and company operations throughout the world. She implemented procedures for clinical document review and tracking, managed worldwide regulatory agency inspections of clinical trial investigators, managed potential misconduct and fraud cases, developed procedures for major internal clinical audits, and provided leadership and mentoring for the GCP staff. She has presented the principals of GCP at domestic and international investigator meetings. She received her BS degree in Medical Technology from Western Michigan University, in Kalamazoo, Michigan.

Laurie Meehan, Social Media Manager, is an education and consulting professional with over 25 years of experience in both academic and corporate settings. She writes the company blog, eNewsletter, and website content, and manages the company’s SOPs and training. Through her interactions with industry members at conferences and on social media platforms, Ms. Meehan has developed an expertise in Risk-based Monitoring and QA best practices. For 9 years, she was an adjunct faculty member at Immaculata University, teaching math and computer science classes. Prior to her Polaris and academic work, Ms. Meehan worked in the telecommunications industry for 15 years at Bellcore and Telcordia Technologies. There, she developed course curricula, and consulted with global telecommunications companies about implementing and positioning data services. Her systems engineering work includes designing interfaces between network elements in the public telephone system and developing requirements for Voice over IP applications. Ms. Meehan holds a BA degree in Computer Science from La Salle University and an MS degree in Computer Science from Drexel University, both in Philadelphia.

Kathleen Dreyer, Operations Manager, has over 35 years of administrative, managerial, and customer service experience in professional, elected, and volunteer positions. Prior to joining Polaris Compliance Consultants, Ms. Dreyer was an office manager at a law firm in North Carolina. In addition to other office-related skills, she has long been involved in the management of budgets and personnel from her positions as a Board of Education Trustee, a Trustee of a Senior Citizen Housing Complex, a Board Member of her Home Owners’ Association, and numerous other activities during a varied career. Ms. Dreyer holds a BA degree in History from Georgian Court College (University) in Lakewood, NJ.

Tina Pilati Stevens, Quality Consultant, has over 25 years of experience in the pharmaceutical industry. She began her career conducting bench research in a Molecular Pharmacology laboratory for a major pharmaceutical company.  She then moved into clinical research for pivotal Phase III trials, first as a monitor, then as a project manager.  As an experienced independent contractor, Ms. Pilati Stevens has worked with multiple companies in several therapeutic areas, performing auditing, training, writing, project management, and document quality control.  She received her BS degree in Biology from East Carolina University in Greenville, North Carolina.