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.
- Data Management.
- Single lab for all studies.
- Financial Stabilit.
- A Dedicated tea.
- Technical expertise and experience Support the launch of a test
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 the trial.
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 month.
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.
Following are some of the examples of Central Lab