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Quality Assurance

L3 In-Vitro Diagnostic Clinical Trials

 

As experts in the In Vitro Diagnostics (IVD) space, we provide comprehensive services to assist organizations with quality and regulatory strategy, and tactical execution.

 

Our team can help fulfill regulatory needs by working with your team or conducting an independent assessment. We align with your resources to focus our expertise in the areas you need, at the time you need.

L3 Quality and Regulatory Services Include:

  • ISO 13485 gap analysis to the new 2016 regulatory standard
  • Implementation of a compliant QMS to meet ISO 13485:2016
  • Internal and Critical Supplier QMS Audits
  • Management of Quality and Regulatory documentation Assistance with EU IVD Classification to meet the new IVDR Compilation and updates to European Technical Files
  • Implementation of an effective Post-Market Surveillance system
  • Coordination with the notifying body to update CE Mark of IVD products

Team

Our team is led by Dr. Mary Nunnally, and includes clinical trials professionals and consultants with extensive experience in in-vitro diagnostics clinical trials.

Dr. Mary Nunnally

Dr. Nunnally heads L3’s Quality and Regulatory Compliance division. Her extensive experience stems from working from within major companies and as President of Translational Medicine, LLC, her own consulting agency, for IVD and Medical Device companies such as Invitrogen, Venaxis, Sontec Instruments and Ceragenix. Dr. Nunnally holds a Ph.D. in Biochemistry from Johns Hopkins University School of Medicine and a B.A. in Genetics with Honors from University of California, Berkeley.

Jane Edwards, CCRA, Vice President, Clinical Trial Services

Over the course of two decades in the diagnostics industry, Ms. Edwards has proven to be a leader in various disciplines of the IVD business. Ms. Edwards leads the L3 Clinical Trials CRO and data management services focused on assisting diagnostic and medical device companies in generating clinical trial data for regulatory approvals. Her experience encompasses project management of both small and large clinical studies, global clinical research and operations, regulatory affairs, medical writing, technical services and clinical training on many different platforms with an emphasis on POC technology. She has successfully authored multiple study protocols and executed studies in the areas of cardiovascular, diabetes, nephrology, toxicology, infectious disease, oncology, and coagulation. Her key areas of responsibility have included product clinical trial strategy, study protocol development, clinical operations oversight, clinical trial management, data management, project management, regulatory strategy and technical team implementation and development. She is a certified data management designer with iMedNet and is a member of the Association of Clinical Research Professionals.

Chermaen Lindberg, Partner

With more than 20 years of experience in the healthcare industry, Ms. Lindberg is a founding partner of L3 Healthcare. Her understanding of the day-to-day challenges that companies face while undertaking clinical research and marketing initiatives stems from working in medical device and diagnostics companies such as SafeSkin (San Diego, CA), Biosite (San Diego, CA), and as a consultant both independently and since co-founding L3 Healthcare. Ms. Lindberg lead the project to establish the L3 Clinical Trials division of L3 Healthcare to help improve the services, quality and pace of clinical trials for sponsors under tight budgetary constraints, limited resources and short timelines. A data management and technical guru, Ms. Lindberg is a certified clinical software designer for iMedNet. Previously, she worked with multiple clients to streamline and standardize processes to assist with positioning clinical, economic and operational outcomes studies, and collect and automate valuable health and economic market data demonstrating product impact on clinical outcomes. Ms. Lindberg lead the restructuring of Biosite’s Marketing Communications department resulting in nearly $1M in savings, and has earned other operations and marketing awards for ingenuity and creativity. Ms. Lindberg received her Bachelors in Business Administration from Cal State San Marcos. She is passionate about her work and now resides in Canada with her husband and two children.

Karen Copeland, Ph.D., Analytics and Biostatistics / Consultant

With over 15 years of experience in clinical and healthcare statistics, Ms. Copeland brings extensive biostatistics expertise in working with various medical device and diagnostic teams spanning clinical affairs, R&D, quality, manufacturing, marketing, and regulatory. She has developed statistical plans and analyzed clinical trial data for FDA and CE marking submissions of IVD products. She has more than 20 years of experience in enhancing the analysis and application of complex data using advanced software methodologies. Prior to working with L3, she founded Boulder Statistics where she provided statistical consulting services to clients and co-authored several clinical articles and posters with study investigators. She is also the co-author of two books on statistics, has been an invited speaker and presenter at several JMP User Conferences (for statistical software), and an invited presenter and current member of the American Statistical Association. Before establishing Boulder Statistics, Ms. Copeland served as Research Statistician at PPG Industries in Pittsburgh, and also as Visiting Professor at Macalester College in St Paul, MN. Ms. Copeland earned her M.S. and Ph.D. in Mathematical Sciences from Clemson University, and B.A. from St. Olaf College in Minneapolis.

Rachelle D’Souza, Regulatory / Consultant

Ms. D’Souza began her career in regulatory compliance in 2007. She has provided Regulatory Affairs, Quality Assurance, Clinical, Pharmacovigilance and Medical Information support to the pharmaceutical, biologic, generic, natural health product, dietary supplement, medical device, cosmetic and food industries. She has developed regulatory strategies for product market authorizations and site approvals, as well as independently prepared regulatory submissions for diverse products. Ms. D’Souza has designed, implemented, and maintained global quality, pharmacovigilance and medical information systems. She has secured product and site approvals from Health Canada and the FDA.