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Pharmaceutical Solutions
Reduce risk and accurately forecast recruitment
with Clinical Trials Simulator
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Paper
Simulation Solutions for Clincal Trials (form required)
Video
Click on the image above to view a short video
overview about Clinical Trials Simulator with optimization.
Pain
Clinical studies account for almost
half of the over one billion dollar cost of drug development.
More than 80% of all clinical trials experience significant
delays, the cost of which can exceed $35,000 a day.Patient
recruitment and retention in clinical trials are widely
recognized as the leading clog in the new drug development
pipeline. The unfortunate result of this problem is
that pharmaceutical, biotech, and medical device companies
spend millions in additional development costs –
and lose hundreds of millions in revenue.
Cure
Clinical Trials Simulator is a user friendly decision
support technology that takes into account all the inherent
variability in Clinical Trials and generates realistic
data on how patient recruitment will perform so you
can make better decisions, faster.
Clinical Trials Simulator’s design and easy to
use interface gives you the power to:
• Experiment with and optimize the number of
sites any trial will require.
• Mitigate risk around recruitment by accurately
projecting “True” patient enrollment and
retention.
• Accurately project trial milestone dates such
as FSFV, LSLV or close out.
• Accurately forecast the cost of the optimal
trial solution.
Methodology
1. Visualize
Determine how your current site and patient recruitment
plans will realistically perform.
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2. Analyze
Define study plan options such as:
• Number of sites per country
• Site schedules
• Patient enrollment rates
• Site recruitment rates
• Protocol modification
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3. Optimize – New True Optimization!
Clinical Trials Simulator can now automatically find the optimized site selection combination and patient recruitment plan at the lowest cost AND closest to the clinical trial milestone delivery dates.
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CLINICAL
TRIALS SIMULATOR ADVANTAGE
Designed for clinical trials likely to exhibit uncertain
recruitment performance, ProModel’s Clinical Trials
Simulator will help you mitigate risk during planning
and execution of clinical trials by:
• Predicting accurate site and patient recruitment.
• Selecting the optimal list of test centers from
a known list of centers using the optimization feature.
• Reducing the risk around projecting study milestones,
fulfillment and completion.
• Reliably predict the resources, money, and API
requirement times to execute a trial.
• Providing a profile of FTE requirements that
will be required to coordinate study activity.
• Enabling decision makers to manage and adjust
to events of the actual trial while it’s being
conducted.
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Inputs
• Center Recruitment Characterization
(or estimates)
• Country Inclusion Definition
• Center List & Definition
• Qualification delays
• Costs
• Recruitment Protocol Definition
• Number of patients required
• Diversity requirements
• Pharm Sci Requirements
• Forecasted Trial Milestones and Completion Timing
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Outputs
• Accurate projection for protocol completion
date and cumulative cost
• Accurate projection of site and patient recruitment
rates
• Ongoing trial monitoring (compare actual vs.
projected)
• Optimized list of “Best Choice”
test centers for use in the clinical trial
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