Field of the invention:

The invention is in the field of Clinical Research and more particularly relates to clinical trial budget preparation and outsourcing of services.

Background of the invention:

Clinical trials budgets have been traditionally managed using spreadsheets wherein all the project related activities are listed and associated costs are assumed as per the User knowledge of the scope of work for the clinical trial project. Although, all research facilities have robust clinical teams that can develop a clinical trial design from a scientific perspective, many such organizations lack financially and operationally experienced personnel to create a detailed budget including all applicable activities and their costs. Hence, the budgets generated in-house at these facilities may not be accurate and may not have accounted for all the essential operational activities and their associated costs.

To conduct a clinical trial, the "sponsor" or the "researchers" may use many different service providers in addition to their own resources and the process used to select between potential service providers can profoundly affect a sponsor's clinical trial budget since service providers can price the same services in significantly different ways and the budgeting processes currently used by sponsors cannot identify these pricing differences without significant time and expense as is described below in greater detail. The current methodology of service provider selection process includes contacting either known or referred service providers to send a request for proposal and share their service fee quotation to undertake the given project work. Each of the service providers then provide a project proposal to the Sponsors/Researchers to short list service providers for further discussion and negotiations on the outsourced scope of work. By this, the Sponsors/Researchers are being restricted to a limited set of service providers. Also the sponsors face a challenging and tedious process of comparing non-standardized quotations which vary in their formats, the list of outsourced activities and the man hour rates from each of the service providers. After a time consuming process of introductory meetings and discussions, a significant number of short listed service providers are eliminated at the final stages of bidding mainly due to a mismatch in the pricing. Since the service provider selection process is time consuming, the Sponsors/Researchers, due to lack of additional time to reach out to a fresh pool of service providers, are forced to select within the remaining subset of shortlisted service providers that match the pricing expectations. The Sponsors/Researchers may have had to compromise on this decision only due to traditional business process where the financial aspects are discussed after a few preliminary introductory and capacity assessment sessions.

Specialized software programs have been developed to handle the logistical and regulatory requirements of clinical trials and to improve clinical trial efficiencies as US7788114 discloses methods to undertake clinical trial budget proposals from various service providers that are entered into the processor and allocated the associated activity costs with the respective standardized services. These are then equalized against standard reference assumption specifications. US20080288285 and US7788114 also describe methods for analyzing budgets for clinical trials but do not generate budgets for the trials. The methods disclosed in these application needs the User to enter his existing budget in to the system into categorized activities for the product to compute per unit costs for these specifications.

Summary of the invention:

The invention addresses the problems faced by the User by providing a predefined, standardized set of categorized operational activities and the financial and operation assumptions based on the trial specifications for computation of the budget. The invention retains the flexibility of editing any/all of these assumptions after a ball park budget is generated, ability to assign multiple personnel from the User team to participate in editing the budget, tracking the changes made, saving the edited and recomputed budgets as new versions of the project budget, obtaining a paper printed copy of the summary of the project budget and invite service providers to bid.

In one preferred embodiment of the invention, the method generates a clinical trial budget based on clinical trial project specifications provided by the User (Sponsors/Researchers) in combination with a predefined set of project specific assumptions, offers complete customizability of all the assumptions, sends and receives Expression of Interests (EOI) from a large pool of service providers, easily compares their line listed quotations and statistical graphical representations and shortlists suitable service providers for further discussions.

Brief Description of the Drawings:

FIG. 1 to FIG. 8 shows an exemplary embodiment input panel for GUI entry making use of tabs, pulldown menus and radio buttons through 6 tabs (Step-1 to Step-5 and Initialize).

FIG. 1 shows entries for step-1 selection.

FIG. 2 shows entry of project timelines in step-1 via a calendar.

FIG. 3 shows entry of the countries sites and patients.

FIG. 4 shows entries for step-2 selection. FIG. 5 shows entries for step-4 selection.

FIG. 6 shows entries for step-5 selection.

FIG. 7 shows entries for step-3 selection.

FIG. 8 shows entries for step-6 selection. FIG. 9 shows GUI customization of project assumptions stored in the processor system.

FIG. 10 shows an example of assumptions stored in the database for every type of trial specific for therapeutic area, phase, country, etc. FIG. 1 1 to FIG. 16 shows a gist of the algorithms used in the processor to compute the parameters.

FIG. 1 1 computes unit costs of project documentation.

FIG. 12 computes unit costs of project feasibility assessment.

FIG. 13 computes unit costs of site management sub-activities. FIG. 14 computes total man-hours of each personnel type against each sub- activity.

FIG. 15 computes total pricing of each personnel type against each sub-activity.

FIG. 16 computes unit costs of Pharmacovigilance sub-activities.

FIG. 17 shows GUI display of the total budget in the form a multilevel pie-chart (sunburst).

FIG. 18 shows the sunburst zoomed-in to show one of its activities and associated costs Eg: Data Management.

FIG. 19 shows the sunburst with the last sub-activity and associated costs selected along with the panel to edit the assumptions used in deriving its costs. FIG. 20 shows the sunburst with the last sub-activity and associated costs selected along with the panel to edit the assumptions used in deriving its costs. Eg: Travel costs. FIG. 21 shows the sunburst with the last sub-activity and associated costs selected along with the panel to edit the assumptions used in deriving its costs. Eg: telephone contacts.

FIG. 22 shows the automatic highlighting of the last sub-activity of DM (data management) where the border is accentuated for the given browsing session.

FIG. 23 shows the automatic highlighting of the last sub-activity of DM (data management) where the border is accentuated permanently and is saved as new version.

FIG. 24 shows GUI line listing of all the projects that can be selected to preview, edit or outsource.

FIG. 25 shows GUI line listing of all the versions of a given projects budget in the form of a collapsible panel. Any version can be selected to preview, edit or outsource.

FIG. 26 shows the edit history of any budget or its versions with the summary of editing details Eg: Editors name, item edited and revised values of each of the items.

FIG. 27 shows the print-budget option where the current inflation rate is defined by User to the processor to compute and generate a print copy of the budget.

FIG. 28 shows a print copy of the budget generated where the level-1 and level-2 costing elements of the total budget are represented.

FIG. 29 shows a GUI in the form of a panel where the list of activities to be outsourced are to be selected.

FIG. 30 shows GUI line representation of the bids received by any given service provider with an overview of the project specifications. FIG. 31 shows GUI line representation of the bids placed by any given service provider with an overview of the project specifications.

FIG. 32 shows the details of the projects proposal sent by the User with the listing is level- 1 and level-2 of the total User costs. FIG. 33 shows GUI entries making use of an input panel to edit and save any component of the proposed budget.

FIG. 34 represents a GUI representation in the form of a line chart the comparison of all the bids received from the interested service providers.

FIG. 35 represents a GUI representation in the form of a line chart the short-listed service providers.

FIG. 36 shows the GUI method of short listing service providers where any given service providers line-listing is clicked to review proposed quotation and the service providers profile.

FIG. 37 shows a GUI method to group together several partial service providers to create a full-service consortium for the Users perusal.

FIG. 38 shows a GUI representation of the several partial service providers that have been grouped together to create a full-service consortium.

FIG. 39 represents the method to send a confirmatory note to the shortlisted service providers and to invite them for further discussions. FIG. 40 shows the top-level flowchart of the invention.

Description of the invention:

A computer based method and system provides an interface (FIG. 1 to 8) to the User (Sponsors/Researchers) in the form of an input panel to enter nonconfidential clinical trial project specifications including but not limited to the following details: name of the trial, phase of the trial, therapeutic area, number of subjects/patients, number of sites and distribution across various countries involved, anticipated screen failure rate, major project time periods, outsourcing checklist of various service sectors like Pharmacovigilance, data management, drug supply management, medical writing, biostatistics and clinical trial monitoring outsoursable activities. These inputs are passed to the processor which has:

1. a predefined categorized listing of project related activities and

2. a predefined set of algorithms for computing the total budget for all types of Trials and

3. a predefined set of project assumptions specific to any type of trial Eg:, the phase, therapeutic area, country and trial duration. The assumptions are related to the personnel type and man-hours for a given unit of each activity, the assumed rates for pass through cost items and a list of general project related input assumptions. The processor assumptions are including but not limited to the following: Monitoring visit frequency and duration of each visit, No. of project related trainings sessions, the unit rates for the individual activities (FIG. 9 & 10). Based on the inputs provided by the User via the input panel, the processor in real time, searches within its database and provides the above three computational components specific to that project (FIG. 11 to 14).

The User inputs are further computed along with the predefined assumptions to generate a budget for the entire trial project. The total budget is a bottom up type of budget i.e. the total budget is made up of a few subcosts, each of these subcosts are further made of their subcosts and likewise upto multiple levels.

The predefined algorithms stated above which combine the User inputs with the processors assumptions are described below in further detail:

Based on the inputs provided by the User, firstly the man-hours of each personnel type required to execute each of sub-activities are computed (FIG. 15) and then these are multiplied with the billable hourly-rates of the respective personnel type (FIG. 16). Such several sub-costs are added up to derive the total of their operationally grouped activity cost. The sum of the cost of these operationally categorized activities are grouped together further hierarchically upwards till the total budget of the entire project is computationally derived.

Eg: Project Report preparation requires 2 human resources: the author of the report and the reviewer/approver, each having a different billable hourly-rate. The costs involved for each of these resources for this sub-activity is their total man- hours required multiplied with the billable hourly-rate (eg. 50 hours of a Project manager x USD 90 per hour for a Project Manager resource = 4500 USD is the cost of using a PM towards this activity). The total man-hours is the arithmetic product of the time (in hours) for completing one-unit task, in this case, preparation of one report and its review multiplied with the total no. of reports that are anticipated throughout the life of the project (eg 1 hour of project managers time per report x 50 reports = 50 hours). The unit-time for completing one report is selected from the pre-defined database which is specific for a given type of project and countries involved. The total no. of reports anticipated in the life cycle of a project is computed by dividing the duration of the project by the frequency of the reporting schedules (weekly, monthly etc.). As stated earlier, the project duration is provided by the User and the frequency is selected from the predefined database which is specific for a given type of project and countries involved. Further, the cost of report review is added to other subcosts similarly derived to computationally arrive at the next hierarchical costing level. Likewise, higher costing levels are computed by summing up costs of categorized costing elements till one single value that is the total budget/cost of the project is derived.

If multiple countries are involved, the individual country rates and man-hours vary for each country. Both the average as well individual country costs of all sub- activities are computed and saved which can be optionally displayed to the User.

The predefined project assumptions stored in the database of the processor are periodically updated by the administrators of the processor based on the market intelligence and assessments of prevailing pricing and operational trends. This intelligence is derived manually as well as dynamically/automatically from relevant offline and online information portals and analysis of service provider bids.

These computed budget values are passed to the front end of the processor where the budget is graphically rendered and displayed in the form of interactive multilevel charts. In one preferred embodiment of the invention, a multilevel doughnut chart, also called a sunburst chart is used to graphically represent the budget (FIG. 17). The sunburst can be zoomed in or drilled down to examine, edit and save any of the hierarchical levels of the budget. The centre of the sunburst chart represents the total cost and radially outward levels represent the subcosts (FIG. 18).

On clicking any of the last wedges (i.e. the outermost or the last sub-costs of the hierarchical budget), the predefined assumptions corresponding to that particular project activity cost appear in a panel (FIG. 19 to 21). The User can edit these assumptions and store the changes as a new version of that trial project's budget. The User can also edit their own study specific inputs (provided earlier), the predefined study assumptions made for that project and the predefined hourly rates for all the study personnel involved.

When more than one country is involved in the study, the monitoring costs are computed for each country separately and added to the total. On the sunburst, a global average of the predefined assumptions is shown for User convenience. Editing these rates would proportionately correct the corresponding values for each country and the total cost is recomputed and graphically rendered again in the form of the sunburst. The User can choose to review, edit and save each country's hourly rates and assumptions as well. Cost items visited during a given browsing session remain highlighted for that session and likewise those that are edited and saved are highlighted permanently (FIG. 22 & 23). A listing of all of the User projects along with the several edit versions if any for each project are displayed to the User to select and work on a given project version (FIG. 24 & 25). A cumulative summary of changes made by the User or their assignee are listed in a collapsible panel (FIG. 26). A summary of the budget can also be printed out (FIG. 27 & 28). A separate login portal is provided for the processor's administrator to add/delete/edit project specific assumptions in the database. Banners of suitable service providers are advertised to the User. The service provider details are stored in the database. Each service provider would have signed up and provided their company profile with/without bidding specifications and filters. The processor compares the User requirements with the service providers competence and their bidding filters and those service providers who closely matches the project requirement from an operational and financial perspective are displayed to the User. The service provider profiles are categorized in the processors database on their man-hour rates, therapeutic and phase expertise, country presence etc.

User can select a few or all service providers and seek an EOI from each of the service providers simultaneously in real time (FIG. 29). The invited service providers can then review the project specifications, the man-hour pricing rates and scope of work (FIG. 30 & 31 ). Service providers can edit, save multiple edited versions (FIG. 32 & 33) and revert to the User with an EOI if they desire to participate in the bidding process with the final version of their quotation.

Only non-confidential, broad-based trial specifications and not the actual project name, molecule details or protocol specifications are mentioned upto this stage of initial engagement/handshake between the User and service providers. The proposals sent by the service provider are displayed to User as line listings and statistical graphical representations of the categorized service providers and their quotations (FIG. 34). User can filter and review the quotations based on pricing, scope of service offered (full or partial), regions covered, experience of service provider (FIG. 35 & 36). User can also group together several partial scope service providers together and save the group as a consortium (FIG. 37). User can shortlist a few full scope service providers or a consortium (FIG. 38). User can send invite to shortlisted Service providers to inform they are shortlisted (FIG. 39) and discuss directly or through the processor with each of the service providers as project specific confidential information is expected to be shared between the parties. The present invention, while illustrated by the above embodiment for clinical trials is not limited there to, but has general application to various other services.