Today much of the clinical
development of new drugs is outsourced by the pharmaceutical industry. This
outsourcing is managed by hundreds of contract research organizations
world-wide ranging from global industry leaders such as Covance to small two
person niche companies. The proportion of the work outsourced continues to grow
at a healthy double digit rate and today approaches 30% on average. Laboratory
pathology analysis of blood, urine and other patient specimens is on the other
hand, outsourced at a virtually 100% level with few parameters, usually
biomarkers, being analyzed in the pharmaceutical companies' laboratories.
The central laboratory business is by its very nature a
global business now that the pharmaceutical industry has moved to global drug
development. Unlike contract research organizations a small pathology
laboratory cannot compete and the vast majority of the business is concentrated
in the hands of relatively few, perhaps 20, large players.
Choosing a central laboratory and then contracting with it
are vital to the successful outcome of a clinical trial
Selecting Preferred Providers.
While choosing a laboratory to conduct a specific study,
following points should be kept in mind:
Favorable pricing and better service.
Quality assurance & Quality control.
Single lab for all studies.
A Dedicated tea.
Technical expertise and experience Support the launch of a
Once a central laboratory has been selected, the success of
the relationship will be largely determined before the first sample is
delivered. It is important to define performance expectations at the outset of
the relationship through mutual planning. Periodic meetings between the sponsor
and laboratory provide opportunities for addressing measurements and discussing
areas for improvement across all ongoing studies.
Here are some examples of expectations that could be set
before the first study begins:
Sponsors should provide all necessary information to their
laboratory four to six weeks in advance, thereby giving the laboratory ample
time to set up the study properly. The first three weeks of the setup process
will largely determine how smoothly it runs. There is no surer way to
compromise a study than to give your central laboratory a week to set it up.
After a study has been set up, it is vitally important that the sponsor make
few if any changes, since they can have a cascading effect on all aspects of
Data file setup, including formatting, must be determined,
which typically requires the laboratory to develop and submit a dummy file
showing how data for all patients and all visits will be presented. This often
requires the laboratory to facilitate communication between a sponsor’s clinical
and data management personnel. Data cleanliness is essentially the byproduct of
continuous improvement. The ultimate objective being a clean set of data for
database lock at the end of the study. If a study requires development of new
methods, the sponsor should give the central laboratory sufficient advance
notice. The process is usually time-consuming and cannot be completed in a
Typically laboratories require advance notice for
replenishment; participating physicians cannot realistically expect quality
kits containing all the necessary contents and paperwork to be consistently
delivered in 24 hours.