Lucent Clinical Consulting provides human clinical research expertise to medical device and in-vitro diagnostic companies to accelerate commercial launch of new products, ensure compliance to changing regulatory standards and protect core markets through a winning clinical strategy.
STRATEGIC CLINICAL CONSULTANT SERVICES:
• Define Clinical Program Strategy and Design Clinical Protocols for Medical devices (Class II, Class III, de novo, combination products, humanitarian device exemption)
• Design Global Organizations and Grow High-Performing Clinical Teams
• Perform Corporate Due Diligence for Clinical-Stage Medical Products
• Define Commercialization Pathways for New Technology
• Plan Clinical Evidence for New Products (market offense) & Core Products (market defense)
• Execute Clinical Risk Management Methodology with Leading Indicators
• Evaluate Clinical Quality System Compliance (architecture, audit, SOPs, templates, work instructions, training)
CONTACT:
• kimberly.oleson.consulting@gmail.com
Company Details
- Founded
- -
- Address
- Greater Minneapolis/st. Paul, Minnesota 55421, Us
- Industry
- Medical Device
- Keywords
- clinical research, medical device, regulatory standards, ISO 14155, ISO 20196, Class II, Class III, FDA, Good Clinical Practice, GCP, Biotechnology, Validation, Risk Management, GCP Consultant, Regulatory Submissions, Code of Federal Regulations, 510(k), PreMarket Application, Clinical Trials, MDR, IVDR, Clinical Operations.
- HQ
- Greater Minneapolis/St. Paul, Minnesota
Lucent Clinical Consulting Llc Questions
Lucent Clinical Consulting Llc's website is https://www.linkedin.com/in/kimberly-wong-oleson/
Lucent Clinical Consulting Llc's LinkedIn profile is https://www.linkedin.com/company/lucent-clinical
Lucent Clinical Consulting Llc's industry is
Medical Device
Lucent Clinical Consulting Llc's top competitors are
Axis Medical Extrusion,
Minnesota Timberwolves,
Apollo Medical Extrusion,
Buymed,
Abbott,
Dexcom,
The Fda Group,
Deeplook Medical,
Indispensable Health,
Minitubes.
Lucent Clinical Consulting Llc's categories are Medical Device
Lucent Clinical Consulting Llc's founding year is 2020
