ACCELERATING DIAGNOSTIC INNOVATION AND COMMERCIALIZATION
A Full-Service Clinical Research Organization Focused on In Vitro Diagnostics (IVD).
WE ARE LAKESIDE LIFE SCIENCE
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.
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.
Analytical protocols released and implemented since 2020
Clinical protocols released and 26 implemented
IVD related Patents
FDA submissions with none denied or withdrawn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
Biotechnology Industry – from start-up to mature
Pharma: Companion Diagnostics (CDx)
Other CROs to augment their services
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.
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