After celebrating 10 years of providing global central lab services, we wanted to present a blog series to highlight the changes we’ve experienced. 

The first central lab was conceived in 1986, after industry experts realized the challenges assigned to acquiring data from multiple local laboratories with varied standard operating procedures, reference ranges, protocols and testing methodologies. Since the advent of this now billion dollar industry, there have been many challenges that are worthy of discussing. 

We are beginning our blog series on the topic of, “Hybrid Central Lab Model” and look forward to your comments!

Historically, central labs initially partner with a regional lab when entering a foreign market until sufficient business warrants the investment to build its own lab facilities. This wholly owned central lab model provides advantages that include data integrity, homogenous data integration and functional controls. However, upon building a new, costly lab, disadvantages may include the need to outsource esoteric tests due to narrow depth of testing, limited regional expertise regarding logistics, and regulatory guidelines.

New operational hybrid approach allows sponsors to take advantage of established, regional central labs while benefitting from advanced data management systems for the centralization and harmonization of test data.

Central labs like ACM Global have effectively developed an alternative “hybrid central lab” model that combines the advantages of a long-standing regional lab with a broad test menu, a rich database of historical test results, deep regulatory expertise, and an established local office with internal staff to manage everything but the test itself.

This leverages local testing experience such as identifying anomalies based on local dietary or genetic variations, which can significantly impact reference ranges, and the breadth of its test menu. With a local staff, data is integrated immediately with the centralized database, and shipping as well as logistics are navigated at the local level, which means tighter specimen controls and lower total costs to the sponsor.
 
The hybrid lab model eliminates the need for costly investments in building a “wholly owned” lab, while ensuring high data quality in collaborating with “wholly owned” employees that know and follow our standard operating procedures (SOPs), good clinical practices (GCP), and understand local restrictions and requirements.

We would certainly like to hear your opinion and thoughts on the hybrid central lab model, or any interesting industry insights regarding the evolution of central labs.

Thanks for reading, and look for our next blog post “Maximizing Test Data Capture.”  Also, we encourage you to visit us on Facebook.com/ACMGlobalLab and Twitter.com/ACMGlobalLab for industry news, ACM Global announcements and exciting events. 

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