The ClinReg team is composed of experts from a range of disciplines, ensuring that our clients benefit from our remarkable depth of regulatory experience and clinical understanding.
Judy F. Gordon, DVM, founder and president of ClinReg Consulting Services, has over 20 years progressive clinical, regulatory, quality and R&D experience in the pharmaceutical and medical device industry. She has worked to gain FDA approval for multiple PMAs for Class III devices, and has made many presentations to Advisory Committees. She has also directed clinical trials of biologics, pharmaceuticals, and Class I, II and III medical devices, from protocol development through clinical reporting to FDA.
Furthermore, Dr. Gordon has served as the industry representative to Medical Devices Dispute Resolution Advisory Panel to FDA and the Ophthalmic Devices Advisory Panel to FDA.
Dr. Lee Kramm is a board certified Ophthalmologist with a Masters' degree in Biomedical Engineering. He earned his graduate degree from the Tulane University School of Engineering and his medical degree is from the University of Miami School of Medicine. Following medical school he received general and surgical training in Ophthalmology from the Rocky Mountain Lions Eye Institute at the University of Colorado in Denver. Dr. Kramm served for five years as a medical officer and scientific reviewer in the Division of Ophthalmic, Neurological and ENT Devices in the Center for Devices and Radiological Health, FDA. In his position as a medical officer at FDA, Dr. Kramm reviewed a variety of ophthalmic devices and served on several internal FDA working groups whose goal was to improve and bring consistency to premarket regulation and clinical evaluation. During his tenure at FDA, Dr. Kramm reviewed pre-IDEs, IDEs, PMAs, 510(k)s, Humanitarian Use Designations (HUD), Humanitarian Device Exemptions (HDE), Class I/II device recalls, combination products and requests for designation (RFD).
Yi Jing Duh, PhD has 15 years experience as a senior statistician and manager of statistical services, including responsibility for clinical database development and validation, SAS programming and output in support of PMA and NDA applications.
Yi Jing has provided statistical sample size calculations and statistical sections for the clinical study protocols and has participated in the Case Report Form and database designs. Yi Jing also interfaces with FDA clinical and statistical reviewers and has participated FDA panels.
Eeke Romo, DSc is a Dutch-trained physician with extensive experience in design and conduct of experiemental research studies in an academic environment (UC Irvine) as well as clinical trials in support of product registration, with 10 years of experience at Baxter Healthcare, Edwards Division and at Theracardia, a venture-backed private company.
Dr. Romo prepares clinical study protocols and reports for FDA submissions, develops table formats for data reporting, reviews and prepares adverse event summaries, and has prepared final clinical reports for 6 original PMA submissions.
Mr. Kair has more than 25 years of experience in the medical device industry, clinical research and quality assurance. He has been directly responsible for overseeing multiple clinical investigations, each involving 150 to 800 patients, and received FDA premarket approval for more than 70 ophthalmic medical devices.
In addition to regulatory submissions, Mr. Kair has extensive experience conducting clinical audits in conformance with the Good Clinical Practices requirements of the International Conference on Harmonization and ISO 14155, and is well versed in the conformity assessment requirements of the EU Medical Device Directive, compilation of technical files, design dossiers, investigator brochures and implementation and coordination of clinical trials in Europe.
Helene Spencer has over thirty years experience in regulatory affairs and quality assurance specializing in medical device start-up companies bringing innovative technology to the market in the US and Europe. Her experience includes Class II and Class III medical device approvals, and designing and implementing quality systems in compliance with FDA and international regulations. Prior to her current consulting for medical device companies, Helene served as Vice-President of RA/QA at Glumetrics, a company with novel technology for continuous glucose monitoring, and Genyx Medical Inc., where she gained FDA approval of a PMA a permanent polymeric implantable device for the treatment of urinary incontinence. This approval culminated in the acquisition of the company. In addition to urology, Helene's regulatory, clinical research and quality assurance experience includes medical devices in a variety of clinical applications including intcrventional ncuroradiology, interventtonal cardiology, critical care medicine, neonatology, anesthesia and surgery. She has served on the management boards of start-up companies, of which four were acquired and one became a public entity. Helene currently serves on the Board of Directors for Orange County Regulator)' Affairs Discussion Group (OCRA) and has assisted in coordinating activities for the OCRA Risk Management Networking Group and other educational programs for OCRA.
Maureen Johnson is a registered nurse and medical writer with over 20 years of regulatory experience in the medical device industry. A regulatory consultant since 1997, Maureen joined ClinReg Consulting Services in 2003. She has extensive experience in medical device reporting and complaints and is an active member of the OCRA MDR Network Group, where she has led productive discussions between industry and FDA. She has been instrumental in supporting companies introducing novel technologies and establishing precedence for MDR/Vigilance reporting. In addition, Maureen has written manuscripts for publication, white papers, IDEs, 510(k)s, and PMAs in various medical fields. In addition to her nursing degree, Maureen’s educational background includes a bachelor’s degree from UCI, a certificate in pharmaceutical medical writing, and a certificate in scientific and technical writing.
Debe Deck is a regulatory affairs professional specializing in both FDA and international registrations. Over the last 12 years, in positions at Chiron Vision, B&L and as part of ClinReg Consulting Services, Debe has gained worldwide approvals for a wide range of medical devices through registrations in the EU, Canada, Australia, Latin America, South Africa, and Pacific Rim countries.
She has extensive experience in planning and conducting International Regulatory Affairs activities in support of investigational (clinical) and registration (marketing) applications for intraocular lenses, lens inserters, excimer lasers, microkeratomes, corneal storage media, viscoelastics in over 25 countries. She has also interacted with U.S. and international regulatory agencies.
Gretchen Neumann has over 15 years of experience in the medical industry managing clinical trials and has been with ClinReg Consulling since 2003. Over the course of her career, Ms. Neumann has managed all aspects of multiple site clinical trials including investigator recruitment, obtaining IRB approvals and training surgeons in the use of investigational devices in the areas of ophthalmics, cardiovascular, neurology and general hospital. In addition, Ms. Neumann has prepared original IDE applications including amendments, supplements and annual reports, developed clinical standard operating procedures, developed protocols for database software validation, and handled all FDA and IRB correspondence. Ms. Neumann also has extensive experience in conducting clinical audits in conformance with Good Clinical practice and monitoring of clinical trials for Class III significant risk devices to verify conformance with 21 CFR Parts 50, 56, 812 and GCP.
Sara Culver is the Office and Production Manager of ClinReg Consulting Services, Inc. She has been a part of the ClinReg Consulting Services team since 2003. Ms. Culver is responsible for all aspects of the day to day activities in the office, as well as the organization and production all FDA submissions and supplements including LDEs, PMAs, INDs, 510(k)s, Annual reports etc. This includes formatting, editing, proofing, and the final QC of documents prior to production and shipment to FDA. Ms. Culver has also participates in the compilation of patient information booklets, physician training booklets, SSF.Ds, CRFs, protocols and many other various documents submitted to FDA. As office manager, Ms. Culver has assisted clients with small business qualifications, payment to FDA for submission review, key 1 data entry for clinical studies, organization and recruitment of DSMB members, FDA panel preparation and organization of required documents, and assistance in completion of FDA submission cover sheets, certifications, and product/facility registrations. Ms. Culver is responsible for managing all FDA correspondence and communication logs as well as overseeing all administrative staff.
Scott has worked in the technical sciences since 2006. He is familiar with clinical database management system, such as Clintrial, and the components that support the clinical system (ie. Oracle, Microsoft SQL Server). Scott has validated and verified newly developed systems that is necessary to meet FDA's 21CFR Part 11 requirements. He has also operated diverse computer systems and continues to be an integral part of ClinReg's diverse team.