Understand the ClearTrial Model

The ClearTrial application calculates the level of effort, costs, distributions, and timelines for plans using the logic and work breakdown of the current release. This set of calculations is referred to as a cost model and each cost model is identified by the ClearTrial release with which it is associated.

For example, ClearTrial release 5.3 has a cost model of "5.3." Each ClearTrial release, beginning with release 5.3, will have its own cost model available. ClearTrial releases earlier than 5.3 do not have a cost model available.

ClearTrial supports two assumption models—one for early phase trials (Phase I (Healthy Volunteers) and another for late stage trials (all variations of Phase I (patients) through Phase IV with or without IND).

Each model consists of:

• User input assumptions
• Default values
• Site Approval Schedule
• Subject Visit Schedule
• Monitoring Schedule

Before you can plan a trial, you (or another authorized user) must:

• Create the product to be tested.
• Create a study to uniquely represent the potential trial.

Only then can you create one or more plans for that study to estimate costs and durations according to your assumptions.

The optimal plan for each study for a product can be compiled into a portfolio to provide estimates for cost and time to bring a product to market. Portfolios can also be used to compile the optimal plan for each study expected in some time frame to estimate quarterly, yearly, or other long-range budgets across a suite of products.