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From the Help Desk
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Investigator Grants To ensure that our users are all using the same assumptions when budgeting with GrantPlan, it is useful to review a few of the frequently used procedures.
The first sets of codes involve using a Central lab. GrantPlan has two codes for blood draws, 36415 for simple draws and 36416 for more complex draws. The complex draw is recommended when a sample may be difficult to obtain (geriatric or pediatric subjects). For the shipment of the samples, we suggest 99000 for simple preparation and handling and 99001 for complex preparation and handling processes. In addition, GrantPlan has combined blood draw with preparation and handling codes, T0701 for simple and T0702 for complex. If laboratory assessments are performed locally, GrantPlan contains benchmarking information for the individual tests performed at the site. |
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The visit codes available in GrantPlan help users group activities together that oftentimes occur at the same time. 99205 is suggested for the initial examination, usually at a screening or baseline visit, and includes a comprehensive medical history, comprehensive physical exam with vitals, and complex decision making by the physician. For visits that only involve vital signs, 99211 is appropriate. For interim physical exams and/or follow-up outpatient exams, there are a variety of codes to choose from (99212, 99213, 99214) depending on the complexity of the examination and medical decision making on the physician's part.
Clinical Outsourcing
For the clinical outsourcing portion of this issue, we focused on the level of granularity professionals use to develop budgets in CRO CostPro. It is our experience that budgeters should determine the level of granularity necessary for understanding costs in obtaining consistent, transparent and accurate budgets. Having the ability to break out very high level activities into several detailed activities can provide the flexibility necessary to manipulate budget estimates. For example, the activity Develop Monitoring Guidelines may consist of following sub-activities: Design Monitoring Guidelines, Review Monitoring Guidelines, Approve Monitoring Guidelines, and Print Monitoring Guidelines.
Having the flexibility to build your estimates with variable levels of detail helps users develop consistent, transparent and accurate budgets. One user may opt to budget at the high level "Develop Monitoring Guidelines" which would include all sub-level tasks, whereas another user may opt to only select Design, Review and Print as outsourced pieces of the high-level task, keeping Approval in-house. These detailed activities can be selected to budget for exactly which parts of the activity will be outsourced, allowing for individual insight into each task instead of over-inflating budgets with portions of activities that may always be kept internal.
As always, please send any budgeting, forecasting, or technical questions you may have to our help desk: help@ttc-llc.com.
Please Note: Slovakia recently changed its national currency to the Euro. GrantPlan and CRO CostPro have been updated accordingly. Current studies in this country will not be affected unless the "Update Exchange Rates" button is used on the Countries Tab.
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Company Specific
Bid Grids - CRO CostPro™
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Most companies utilize a Task Responsibility Matrix (also known
as a Bid Grid or Activity Grid) when requesting
proposals from CROs. When comparing proposals,
the Bid Grid is one of the most important documents
to compare to ensure all CROs utilize the same
assumptions to formulate their estimates.
We understand that sponsor companies have put endless hours into
developing and improving their Bid Grids. To
ensure companies will be able to continue to
maximize the energy and time they devoted to
the construction of their Bid Grids, CRO CostPro™
was built with the flexibility to utilize company
specific bid grids. Through a mapping process,
a company's grid is uploaded to allow for users
to interact with a grid that they are familiar
with and with categories and activity descriptions
that match up exactly to how they do business.
No change is necessary in the way the client
does their outsourcing or uses their Bid Grid. |
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Also, having the ability to fine-tune a budget to fit the exact work performed is as helpful to the sponsor company as it is to the CRO providing the proposal. Providing as many details as possible up front with precise assumptions will enable the CRO to provide a more accurate estimate when the bid is returned as well as allow for accurate cost-comparisons between original budget numbers and CRO estimates.
When a new study is created, a user will work off of their grid to create a budget estimate, making modifications to the activities and assigning responsibilities to each task to customize their budget to fit the current study. By ensuring all users are starting from the same version of their bid grid, budget consistency and accuracy will grow as users will all begin with the same set of activity assumptions. Over time, some companies have opted to utilize CRO CostPro™ to help add granularity to their current grid, increasing transparency into the costs of activities within their budgets.
Many users have also used CRO CostPro ™ as a Bid Grid development tool, with access to the TTC Master Grid of activities, a grid can be developed and modified to fit a company's workflow and expectations. | |
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Cost Comparison
of Clinical Outsourcing Activity Categories
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The use of CROs to conduct clinical trials, including data management, has increased over the years, and will most likely continue to represent a significant part of many companies' clinical research efforts. Consequently, sponsor companies need to be able to budget the costs of these outsourced studies as effectively as possible. No one is pleased when a sponsor company requests bids for a study, or asks a preferred provider to submit cost estimates, and the lowest submitted figures are substantially above the amounts expected by the sponsor company.
During the budgeting process a refined bid grid enables a company to establish both the overall outsourcing budget and the expected budget for individual outsourced studies. The bid grid also enables companies working with preferred providers to forecast costs for individual projects more easily. Equally critical are the cost numbers that go into that bid grid. |
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For completely outsourced studies, study conduct represents the largest portion of the project, followed by project management and then data management. However, as the number of sites in a study increases so does the relative cost importance of project management and data management.
For more information about Bid Grids, CRO Selection & Management,
and/or utilizing cost benchmarks to more accurately
forecast the cost of outsourcing clinical
trials, please contact help@ttc-llc.com. |
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"Our help desk is available whenever you have a question or need assistance with GrantPlan®. Simply email an inquiry to help@ttc-llc.com and one of our client service professionals will respond to you in a timely manner." |
