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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 sponsors, CROs, IRBs, and investigational sites to assure compliance with GCP regulations and has trained many clinical research professionals in GCP compliance. She’s the author of a reference book entitled “Handbook of SOPs for Good Clinical Practices” and 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.
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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.
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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.
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Tina 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. 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.
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