LAKESIDEMURAL-(75-of-148).jpg

ACCELERATING DIAGNOSTIC INNOVATION AND COMMERCIALIZATION

A FULL-SERVICE CLINICAL RESEARCH ORGANIZATION FOCUSED ON IN VITRO DIAGNOSTICS (IVD).

ISO 9001:2015 Certified >

 

WE ARE LAKESIDE LIFE SCIENCE

LAKESIDELIFESTYLE-(242-of-267).jpg

Lakeside Life Science is an industry leader and full-service clinical research organization.  We provide the scientific and clinical expertise to help our clients complete the journey through the seasons of product development of laboratory tests from concept to FDA clearance and commercialization.

LAKESIDELIFESTYLE-(19-of-267).jpg

OUR SERVICES

We are results oriented with the scientific and clinical affairs expertise to execute product design and planning for analytical and clinical studies, as well as develop regulatory strategy to achieve FDA approval for new laboratory tests. Lakeside has designed and implemented the protocols to support more than 100 Analytical and Clinical Validation Studies. These studies have led to successful implementation of Laboratory Developed Tests (LDTs) and we’ve had 54 successful FDA submissions.

 

Lakeside Life Science has managed clinical studies in oncology, infectious disease, liver disease and bone metabolic disease across a multitude of testing platforms, from standard immunoassays, PCR, NGS, and more.

PROJECT AND PRODUCT DEVELOPMENT
ANALYTICAL TESTING
 
CLINICAL STUDIES

 
REGULATORY STRATEGY AND FDA SUBMISSIONS

WHY LAKESIDE?

We have the team, the experience, and the culture.  Learn more >

100

Analytical protocols released and implemented since 2020

34

Clinical protocols released and 26 implemented

20

IVD related Patents

195

Publications

54

FDA submissions with none denied or withdrawn

INDUSTRIES WE SERVE

Lakeside Life Science can help IVD manufacturers take new technologies to market sooner and at lower cost by leveraging our expertise, and industry and clinical network resources.  Clients we serve include:

  • Diagnostic Test Developers and Manufacturers

  • Clinical Laboratories

  • Biotechnology Industry – from start-up to mature

  • Pharma: Companion Diagnostics (CDx)  

  • Other CROs to augment their services 

LAKESIDELIFESTYLE-(1-of-267).jpg

ISO 9001:2015 CERTIFIED

Lakeside Life Science is proud that we have achieved ISO 9001:2015 certification, an internationally recognized standard that ensures that our services meet the needs of our clients through an effective quality management system.


Lakeside Life Science is listed on the Good Clinical Practice Network. 

ISO photo.png
LLS_Brand-Elements-04.png

GET IN TOUCH

Lakeside Life Science is committed to exceeding your needs. Questions, comments, or special requests? We’d love to hear from you, so don’t hesitate to reach out today.

171 Daniel Webster Highway, Suite 11
Belmont, NH 03220

603-527-8107

LLS_Brand-Elements-15.png

Thanks for submitting!