Wendy Schroeder has been involved with research and clinical trials for more than 25 years, and has a deep understanding of medical devices including in vitro diagnostics (IVDs) and companion diagnostics (CDx). She has served as a key company stakeholder in the implementation of an in-house contract research organization (CRO) infrastructure for a commercial laboratory moving bench IVD science into clinical validation studies and launching a biorepository of blood samples with annotated clinical data. Wendy has provided research operations oversight for commercial laboratories (Caris Life Sciences, Ashion Analytics) and IVD manufacturers (VisionGate, Inc.) as well as at hospital and clinical sites. She has supported medical device product development including device risk classification, pre-clinical testing and design controls and clinical strategy interactions with the FDA.

Wendy holds a Bachelor of Science in nursing degree from Arizona State University (Tempe, AZ). She is a certified Research Coordinator and Project Manager (ACRP) and a certified Research Contracts Professional (MAGI). She has been an invited speaker and author of peer-reviewed journal publications on molecular diagnostics (MDx), clinical trial billing and IVD/Laboratory Developed Test (LDT) regulatory matters.

CORE COMPETENCIES

• Coordinating clinical trials for several medical device and IVD areas, including implantables, grafts, meters, oncology diagnostics (e.g. 3D cell imaging, blood based exosomes—prostate, colon and breast—, next-generation sequencing [NGS] assays), infectious disease, chemoprevention CDx (surrogate endpoints) and multiplex assays
• In-house CRO infrastructure implementation moving bench IVD science into clinical validation studies
• Sponsor (and site) vendor management for Good Manufacturing Practice (GMP)/Good Clinical Practice (GCP) compliance, including biostatistics, laboratory services, CRO, electronic data capture (EDC), sample collection kits/supplies/shipping/preclinical analytical controls, clinical trial management system (CTMS) and regulatory consulting and submissions
• Clinical Trials Operations Management (Certified Clinical Research Coordinator-Project Manager [CCRC-PM/ACRP])
  • Infrastructure and resource planning
  • Site recruitment, qualification, activation, training, maintenance and close out
  • Protecting patients and preserving the integrity of the data
  • Contracts, budgets and clinical trial billing
  • Trials cost and coverage analysis
• Clinical trial billing determinations based on Centers for Medicare & Medicaid Services (CMS) coverage rules
• Protocol design and budget planning
• U.S. regulations – product risk assessment/business impact on protocol design (significant risk [SR]/Investigational Device Exemption[IDE], nonsignificant risk [NSR], LDT, Clinical Laboratory Improvement Amendments [CLIA], design controls and clinical readiness) and LDT pathway to market
• In Vitro Diagnostic Directive (IVDD) transition to In Vitro Diagnostic Regulation (IVDR) – IVD classification and clinical evidence requirements

RECENT PROJECTS

• Provided strategic direction on clinical trial design, implementation and data management
• Clinical trial management for 510(k), LDT and Premarket Approval (PMA) projects.
• Supported strategic clinical consulting on IVDR clinical performance
• Managed lung cancer assay product development and commercialization

RECENT PUBLICATIONS

• RA/QA Podcast Clinical Investigations: Collecting proof that your device is safe and effective (September 2023)
• Webinar Infectious Disease Diagnostic Devices: The move to at home testing and treatment (Panel Discussion) (24AUG2023)
• Blog Clinical trial cost analysis with site budget estimates (12JUL2023)
• Webinar Clinical trial site budgeting – risk mitigation or budget control? (16MAR2023)
• Publication: “Regulatory and development approaches to research for in vitro diagnostics vs. other medical devices – The same or different?” peer reviewed journal publication in ACRP Clinical Researcher February, 2023
• Blog U.S. FDA EUAs: CRO lessons learned for the MedTech Industry (08FEB2023)
• Webinar Navigating the Landscape for OTC and DTC IVD Tests, Advamed 2022.
• Blog Monkeypox: Not all EUAs are Created Equal. (22SEP2022)
• RAPS (2022) Presentation: IVD Clinical Performance Across Geographies
• HCCA 26th Annual Compliance Institute (2022) Presentation: Research Compliance 101: Fundamentals and Complexities
• Publication: “In vitro diagnostic tests: Ensuring test accuracy and patient safety when used as companion diagnostics” peer reviewed journal publication: online in Vol 10, No 6 of JHA.
• RAPS (2021) Presentation: ISO 20916:2019 – GCPs for IVDs
• Embracing Change Conference for Clinical Research (2021), ACRP Phoenix Chapter Presentation: IVD EUAs and SARS-CoV-2