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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. 

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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:

  • Analytical Validation Study Outline

  • Clinical Validation Study Outline

  • Regulatory Strategy

  • FDA Pre-submission (Q-Sub)

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ANALYTICAL TESTING

Client specific analytical study protocols that meet CLSI guidance

  • Our Protocol Library includes protocols for Chemistry tests, Immunoassays, PCR assays, NGS, Control Products, and more.

  • Samples and Reagent procurement

  • Laboratory Testing in our ISO certified lab

  • Test Data Analysis and Study Reports

 
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CLINICAL STUDIES

Comprehensive clinical study design and execution

  • Study protocol development

  • Site and patient feasibility assessments

  • Site initiation, study start up, supply kitting, management

  • Management of patient recruitment, enrollment and engagement

  • Monitoring, review, and statistical analysis, reporting

  • Clinical Validation testing site selection and management

  • Human factor studies

  • Bridging studies to support reference and historical data, and CDx development

  • Provision of FDA Ready Clinical Study Report

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REGULATORY STRATEGY AND FDA SUBMISSIONS

FDA Pre-submission (Q-Sub)

  • Design and Strategy

  • Prepare and Submit Necessary Documents

  • Manage FDA Meetings

  • Answers to Questions (yours and FDA’s)

  • Obtain Approval/Clearance

FDA Submission

  • Design and Strategy

  • Compile Documents

  • Comply with FDA formatting

  • Manage post submission follow-up 

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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.