Medical Affairs

Lumos has a qualified in-house clinical team with experience in IVD/Medical Device clinical study design, site management, monitoring, statistical analysis, report writing in compliance with Good Clinical Practice (GCP), International Council for Harmonization (ICH) and applicable Codes for Federal Regulation (CFR).

Core competencies include:

  • Clinical Regulatory Strategy (in collaboration with RA).
  • Feasibility, registrational, human factors and post-market study design (US, OUS) / protocol development.
  • Case Report Forms (CRFs) / Electronic database capture (EDC) system development/management.
  • Draft Informed Consent Forms (ICF), ICF process forms, recruitment materials, and other supporting ethics documentation.
  • Ethics submission and oversight.
  • Clinical Site Management (selection, budget, contracts, ethics, screening, enrollment, monitoring, study closure).
  • Vendor management (e.g., EDC, reference labs, kit suppliers etc.).
  • Data management.
  • Data analysis, Clinical Trial Report writing, regulatory submissions, manuscript preparation and submission/management of publication of clinical trial findings (e.g., applicable registries / peer reviewed journals etc.).
  • Essential document file management.
  • Review of product labeling (package insert, product labels).

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