LAKESIDE LIFE SCIENCE SERVICES
Advancing Patient Care Through Expert Product Development and Commercialization Services
FULL-SERVICE CLINICAL RESEARCH
We provide regulatory and laboratory testing resources to support taking laboratory assays from concept to FDA clearance and approval. From product and project planning to analytical testing, clinical trials, regulatory strategy, and FDA submissions, our team is here to support yours and get new technologies to the market faster, more efficiently, and more affordably than ever.
PRODUCT AND PROJECT PLANNING
Lakeside integrates your science with current medical practice to create the correct intended use for your product, and the patients that will benefit from it.
Our Proven Planning Process Provides Clients with a comprehensive strategy with timelines and budgets:
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Analytical Validation Study Outline
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Clinical Validation Study Outline
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Regulatory Strategy
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FDA Pre-submission (Q-Sub)
ANALYTICAL TESTING
CLINICAL STUDIES
Comprehensive clinical study design and execution
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Study protocol development
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Site and patient feasibility assessments
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Site initiation, study start up, supply kitting, management
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Management of patient recruitment, enrollment and engagement
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Monitoring, review, and statistical analysis, reporting
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Clinical Validation testing site selection and management
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Human factor studies
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Bridging studies to support reference and historical data, and CDx development
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Provision of FDA Ready Clinical Study Report
REGULATORY STRATEGY AND FDA SUBMISSIONS
WORK WITH US
Our goal is to advance patient care through expert product development and commercialization services. The Lakeside team is knowledgeable, reliable, friendly, and flexible. From product and project planning to analytical testing, clinical trials, regulatory strategy, and FDA submissions, we're here to support you and get new technologies to the market faster, more efficiently, and more affordably than ever.