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 several 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. In his early career, he designed calculators and computers, and went on to found one of the first retail computer stores in the area to offer complete turnkey business systems and support. Since then, he has designed and managed the installation of fully integrated server rooms in a number of enterprise sectors. As the IT industry has grown increasingly specialized, Ty has preferred to remain more of a generalist, allowing him to install and manage enterprise solutions that 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.

Laurie Meehan, Social Media and Platform Administrator, is an education, training, and platform professional with 30 years of experience in both academic and corporate settings. For 10 years, Ms. Meehan taught college math and computer science classes and operated her own tutoring business for SAT preparation. Prior to her Polaris and academic work, Ms. Meehan worked in the telecommunications industry for 15 years, working with global telecommunications companies on implementing and positioning data services, developing course curricula, and writing technical network requirements. 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.

Lauren Kelley, CCRP, Associate Director of GCP Compliance, has worked for over 36 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.

Paula Nuchols, Quality Assurance Auditor, has over 27 years of drug development experience, with 24 years of quality assurance and compliance (GCLP, GLP, GCP, cGMP).  She began her career in the pharmaceutical industry conducting pharmacokinetic studies in laboratory animals.  She has held QA positions in both CROs and a pharmaceutical company where she performed quality audits of internal systems, analytical chemistry stability data, test methods and specifications, pre-clinical toxicology and clinical study reports, investigator sites, IRBs, clinical and non-clinical labs and vendor qualification assessments.  She has hosted sponsor audits and participated in FDA inspections.  Ms. Nuchols has inspected raw materials, packaging materials and final products for release inspections and has reviewed and approved Master and Batch Production Records.  She has also developed and reviewed Standard Operating Procedures (SOPs).  She has extensive auditing experience in a variety of therapeutic areas including pain, treatment for chemotherapy-related side effects, rheumatology, allergy, gastroenterology, virology, oncology, endocrinology, infectious disease, dermatology, cardiovascular, transplant, ALS/MS and psychiatry.  Her management experience includes supervision and training of personnel on FDA regulations and SOP compliance.  Ms. Nuchols has a BS degree in Biological Sciences from Wright State University in Dayton, OH and an MS degree in Toxicology from the University of Kentucky in Lexington, KY.

John Janeri, CSV/Part 11 Auditor, has over thirty-three years of experience in software engineering, and computer and information system security. He has extensive experience working in all phases of a project’s life cycle, including training, validation master planning, requirements specification and analysis, risk identification/analysis/remediation, creation and execution of test documentation, system design and configuration, policy and SOP development, change control, and system retirement. In his free time, he enjoys long walks with his bride of 30 years (is a mile considered "long"?), woodworking, and beekeeping in Chatham County NC. Mr. Janeri has a BS in Mathematics and Computer Science from Ohio University in Athens, OH, an MS in Computer Science from Northeastern University in Boston. MA, and has completed graduate courses at the University of Texas, the Wang Institute of Boston University, and MIT.

Lisa Olson, CSV/Part 11 Auditor, has over 30 years of experience in the pharmaceutical industry, including technology and compliance roles.  She has worked at a major pharmaceutical company, multiple CROs, and in consulting roles, working with sponsors, CROs, phase 1 units, software vendors, and technology service providers.  She has assisted clients in writing and reviewing computer system validation (CSV) SOPs, performing system gap analyses against 21 CFR Part 11, determining training approaches, and identifying technology-related risks. She’s worked with vendors to obtain acceptable audit responses, and worked with small companies to develop their initial computer compliance approaches.  She’s experienced with EDC, IVR, eTMF, ePRO, medical imaging, portals, data migration planning.  Ms. Olson was on the task force that issued the CDISC “Leveraging the CDISC Standards to Facilitate the use of Electronic Source Data in Clinical Trials,” the DIA publication “Computerized Systems in Clinical Research – Current Data Quality and Data Integrity Concepts,” and co-authored the Barnett International book “The ‘New’ Part 11 and Drug Development:  A Q&A Reference Guide.” She has her BA in Liberal Arts from Albion College in Albion MI.

Susan Meeker, Laboratory Compliance Consultant, has over 25 years experience in the pharmaceutical industry and specializes in GLP, GCLP, CLIA and CAP compliance. She began her career in the analytical lab at a major pharmaceutical company. She moved to the Quality Assurance Unit at a CRO and continued her career in QA at a CRO and then at a sponsor company. As an experienced independent contractor, Ms. Meeker has worked with clients to: conduct audits of analytical, bioanalytical, and clinical labs; prepare for CLIA or CAP certification; prepare SOPs; conduct regulatory training; document lab investigations; audit final reports; and conduct document quality control. Ms. Meeker has a BS degree in Biochemistry from Hofstra University in Hempstead, NY.

Dawn Edgerton, Clinical Data Scientist Consultant, has over 22 years of experience in research computing and 10 years managing clinical trial staff across all functional areas, including project management, clinical operations, data management, data standards, biostatistics, medical writing, and statistical programming. She launched and grew a statistical programming Functional Service Provider for a mid-sized biopharmaceutical company, and led a successful sales team that bundled customized hardware, software, and service solutions to address client business issues. Ms. Edgerton holds certificates in Project Management from UNC and in Regulatory Affairs from RAPS. She is a member of North Carolina Council for Entrepreneurial Development, Pharmaceutical Users Software Exchange, and North Carolina Regulatory Affairs Forum among others. She has an MBA with concentrations in BioSciences Management and Services Management from NC State University in Raleigh, NC, and a BS in Mathematical Sciences with a Computer Science Option from the UNC, Chapel Hill, NC.

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 20 years of experience in GCP QA. 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.

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.

Jean Noblin, Resourcing Manager, has over 24 years of experience in virology research, clinical drug development from Investigational New Drug (IND) submission through regulatory submission, approval and marketing, medical writing, and change management at a major research-based pharmaceutical company and as an independent consultant. She has held positions as a clinical monitor, clinical project manager, medical writer and an International Product Development Team Leader (program director). In addition, Ms. Noblin has over 16 years of experience as a Clinical Resourcing Manager recruiting and managing consultants in clinical operations, medical writing, regulatory, safety and quality assurance for clients in the biopharmaceutical and device industries and serving as the primary client and consultant liaison. She has a BS in Zoology from North Carolina State University and a MS in Microbiology and Immunology from Wake Forest University in Winston-Salem, NC.

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.