Clinical trials have always been complex. But today's studies are fundamentally different from those conducted even a decade ago.
The clinical research landscape has expanded from just over 2,000 registered studies in 2000 to more than 515,000 today. At the same time, scientific advances such as precision medicine, biomarker-driven endpoints, genomic testing and adaptive trial designs have dramatically increased operational demands on sponsors and study teams.
As complexity grows, one function has quietly evolved from service provider to strategic partner: the central laboratory.
The signs are everywhere.
Company-sponsored trials increased 23% between 2019 and 2024, while delayed trial starts rose from 4.5% to 21.8%. Protocols continue to expand in complexity, with endpoints increasing 86% and eligibility criteria increasing 61% over a 14-year period.
Sponsors are no longer managing simple global safety testing programs. They are coordinating biomarker strategies, companion diagnostics, specialty assays, global logistics, data integration and evolving regulatory requirements simultaneously.
Traditionally, central laboratories focused on testing and reporting results.
Today, sponsors increasingly rely on central labs to provide:
Early scientific consultation
Protocol review
Assay strategy guidance
Global logistics expertise
Data harmonization capabilities
Regulatory support
The central laboratory now sits at the intersection of science, operations and data management.
The question is no longer whether sponsors need a central laboratory.
The question is whether they have a central laboratory partner capable of helping them navigate the growing complexity of modern development programs.