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May 9, 2003 | Estimating the costs of clinical trials — and the price of paper — is difficult. That's because a trial may have one patient or 10,000. But Fast Track Systems of San Mateo, Calif., has some of the best data in the industry, acquired directly from major companies sponsoring clinical trials.

Once the facts from many companies have been aggregated, the Fast Track databases and applications are used by trial sponsors to manage costs and bargain with clinical sites. These figures are an estimate of the trial-related costs of one drug, tested in 35 clinical trials and submitted to the FDA for approval. Fast Track does not specifically analyze EDC, but several of these expenses could be affected by more efficient capture, cleaning, and management of clinical data.

Investigator fees 
4,000 patients @ $6,000/patient
$24,000,000

Project management 
35 projects over 7 years
$12,100,000

Site setup, monitoring, and closing 
400 sites x 20 visits x $1,500/visit
$12,000,000

Case report forms 
400,000 forms to enter, clean @ $10/page
$4,000,000

Lab tests
4,000 patients x 6 visits x $80/visit
$1,900,000

Site management
400 sites managed for 1 year each @ $4,250/site
$1,700,000

Study protocols, statistical analysis 
$2,700,000

Total Cost = $58,400,000 

Source: Fast Track Systems



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