NAMSA provides global regulatory, clinical and compliance support to manufacturers of in vitro diagnostics.

We specialize in the design and conduct of IVD Trials by creating smaller, focused teams of IVD experts who customize data collection methods and monitoring plans to meet the unique requirements of these studies.

We have the expertise required to understand site, instrumentation and logistical requirements for the various types of IVD studies. We also have a dozen statisticians based out of our Minneapolis, Minnesota offices, several of whom have experience in modeling IVD studies and performing the associated analysis.

Areas where NAMSA has experience with IVDs:

  • Blood glucose,
  • Hemoglobin A1c,
  • Urinalysis strips,
  • Fusion protein (BCR-ABL),
  • Troponin,
  • Stem Cell Enumeration (CD34+, CD45+),
  • Drugs of abuse,
  • Therapeutic drug monitoring (theophylline, phenobarbital, dilantin),
  • Thyroid hormones,
  • Bone alkaline phosphatase,
  • Deoxypyridinoline and pyridinoline,
  • Luteinizing Hormone (LH),
  • Human Chorionic Gonadotropin (HCG),
  • Streptococcus A,
  • HIV,
  • HLA Typing (DNA sequencing),
  • Cystic Fibrosis,
  • UTI–uropathogen detection,
  • Theophylline,
  • Phenobarbital,
  • Dilantin,
  • hCG,
  • Therapeutic Expertise,
  • Oncology,
  • Anemia,
  • Reproductive,
  • Cardiovascular,
  • Allergy,
  • Adrenal/Pituitary,
  • Bone Metabolism,
  • Autoimmune,
  • Diabetes,
  • Therapeutic Drug Monitoring,
  • Endocrine,
  • Infectious Disease,
  • Fetal Well Being Therapeutic Expertise,
  • Molecular Diagnostics,
  • ELISA,
  • Automated Instrumentation,
  • Immunoassay,
  • Immunohistochemistry,
  • Calibrators,
  • Controls Intended Uses,
  • Diagnostic,
  • Research Use Only,
  • Point of Care,
  • Quantitative,
  • Qualitative,
  • Semi-Quantitative,
  • Companion Diagnostic for melanoma and lung cancers,
  • Pre-IDE coordination and package development,
  • FDA and CLIA Waiver submission, and
  • Studies using leftover de-identified samples as well as prospective studies requiring informed consent.

Project specific examples:

  • Immunoassay kit for detection of sepsis;
  • Early-stage regulatory support to include study design, statistical analysis plan and pre-IDE interactions with FDA;
  • Prognostic assays for breast, colon and prostate cancers with companion therapies;
  • Assist global manufacturer with strategic commercialization planning, including U.S. and international regulatory requirements, resource planning and timelines;
  • Assay for tissue typing;
  • Full clinical trial support for large U.S. manufacturer, including project management, resource planning, site selection and qualification, monitoring, data management, biostatistics and report writing;
  • Immunological assays for prostate, breast and colon cancer;
  • Provide regulatory counsel and FDA interaction support for European manufacturer;
  • Immunological and molecular diagnostics for us in in vitro fertilization;
  • Assist global manufacturer with strategic commercialization planning to include regulatory affairs, resource estimation and timelines;
  • Blood-based assay for screening of colon cancer;
  • Provided regulatory counsel to venture capital group on likelihood, requirements and merits of FDA IVD vs. CLIA pathways;
  • Filed BLA efficacy supplement for blood group reagents;
  • Immunological assay to detect neurodegenerative disease;
  • Assist European manufacturer with indicators for use, regulatory pathway and FDA interactions;
  • Flow cytometry for stem cell enumeration Immunohistochemistry assay to detect prostate cancer, 26 monoclonal antibody-based blood grouping reagents, 2 anti-human globulin products, 13 reagent red blood cell products and supplements to 3 previously licensed reagents Instrument and DNA primers for K-RAS mutation detection kit Point-of-care test for counting blood cells and quantifying hemoglobin content;
  • Regulatory assessment on modifications to blood cell analyzer;
  • Assay to detect marker response to a drug therapy;
  • HgB A1C point-of-care device;
  • Immunohistochemistry assay to detect breast cancer;
  • Genetic marker to detect human papillomavirus (HPV);
  • Regulatory assessment;
  • Molecular genetics assay to detect cystic fibrosis;
  • Cell separation product;
  • CLIA waiver;
  • Genetic screening for congenital indication;
  • Breath sensor array device for detection of lung cancer;
  • Reagents for immunoassay analyzer — chemistry assays, hormone level assays, etc.;
  • Reagent panel for ABO typing;
  • Cancer tissue marker; and
  • Hepatitis diagnostic.

Why choose NAMSA?

  • Regulatory, quality systems and assurance, data management, statistics, and clinical expertise all under one roof;
  • Proven working relationships with IRBs, Central Laboratories and sites for IVD studies;
  • Understanding of the various global regulations as they apply to IVD clinical trials and regulatory submissions;
  • Work with pharma and device companies on companion diagnostics;
  • Frequent contact with FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR);
  • Experience with instrument platforms, systems and database interfaces;
  • Staff includes members with prior laboratory experience (e.g. medical technologists, laboratory management and logistics expertise); and
  • Expertise with studies using leftover de-identified samples and prospective studies requiring informed consent, as well as studies where well- characterized banked samples are utilized.

Additional experiences with IVDs:

  • Pre-Submission meeting preparation and attendance;
  • U.S. Regulatory submissions (IDE, 510(k), PMA, HUD, HDE, BLA, Device Master File);
  • FDA panel preparation and participation;
  • International Submissions (Ethics Committee, Technical File, Dossier, STED) and Registrations (EU, Canada, Australia, Japan, BRIC and more);
  • U.S. Agent;
  • Clinical Evaluation Reports;
  • IVD Analytical Testing;
  • NAMSA now performs IVD analytical testing per CLSI guidelines;
  • Quality Systems;
  • Development and implementation;
  • Audits and gap analyses;
  • Document control process;
  • Design controls;
  • Supplier audits;
  • BIMO Inspection preparation and participation;
  • Clinical study design and protocol development;
  • Qualification and selection of clinical sites and core and central labs;
  • Clinical study and site management;
  • Monitoring of clinical data;
  • Uploading instrument data outputs in lieu of manual data entry for data collection;
  • Data management and statistical analysis for development of the clinical study report;
  • Writing of clinical reports;
  • Custom kit assembly including bar coding;
  • Chain of Custody tracking of shipments nationally and internationally;
  • Knowledgeable in area of IATA regulations;
  • Experience managing ground and Next Flight Out (NFO) couriers;
  • Logistical support for time sensitive testing of samples to central laboratories for therapeutic drug monitoring studies;
  • Data management – Instrument data can be directly into the database via CD/jump-drive or electronic upload through our Electronic Data;
  • Capture (EDC) solutions, reducing or eliminating the need for monitoring of a transcript to source.
  • Expertise in XML, HL7, CSV and ASCII file formats and solutions for high volume upload
  • Experience developing clinical databases for data management tailored to IVD studies (and longitudinal patient data, when required);
  • FDA mandated post-market studies;
  • Registries and retrospective studies;
  • Health Economics studies;
  • Post-market surveillance; and
  • Literature based meta-analysis.