How does the current proposal compare to historical ones? Have efficiencies been gained through repetitive bidding and strategic partner agreements? Have agreed rate cards been applied to the bid? These common questions are difficult for most Sponsors to answer.

Sponsors recognize the role R&D procurement plays in change management, strategy attainment, and study execution. This influence is the primary reason that collecting, analyzing, and reporting on RFP data is instrumental to the future success of your program.

Because all RFx activity takes place in a single digital system, Clinical Maestro SOURCE, you can easily surface data trends and develop metrics and dashboards that inform your reporting, auditing, and forecasting responsibilities. You have an overview of every clinical outsourcing project completed in the past, putting valuable insights at your fingertips and analytics to enable informed decision making.

 Milestone management is uniquely administered in Clinical Maestro to give Sponsors visibility across all stages of a clinical study: planning, roll-out, and close.

Knowing when clinical milestones are achieved often determines payments, dictates governance meetings, and other steering committees. Future milestone dates are difficult to predict and estimating them based on specific cost drivers is not an easy undertaking. Further, determining which unique minor tasks roll up to a specific milestone requires tagging activities to milestones and tracking actuals vs. plan.

Clinical Maestro provides the foundation to estimate and track clinical milestones:

Track Milestones
Milestone dates can be modeled in PORTFOLIO.

Relate Milestones to Payments
Service providers predict milestone dates in SOURCE.

Predict Cash Flow
Actual milestone dates are tracked in LEAD.

Activities (minor tasks) can be tagged to milestones in the administration panel.

SOURCE simplifies milestone management, allowing teams to model outcomes faster and with greater accuracy.

Make payment negotiations easy and efficient so all parties benefit from a fair and balanced schedule.

Clinical service contracts have different types of payment schedules, with common ones being milestone-based, fixed payments and variable (unit completed), or a combination. Cash flow management is relevant to smaller biopharma sponsors as well as the Service Providers. All parties strive to be in a cash neutral situation in which Sponsors are not overpaying and the Service Providers are not operating in “red”.

Model Payment Schedule
Payment schedule can be estimated in PORTFOLIO.

Timing of completed clinical activities can also be modeled in PORTFOLIO.

Increase Predictability
Vendors proposed payment schedule is developed in SOURCE. Payment schedule negotiations can be enhanced through proposal comparison and payment modeling.

Actual activities completed are tracked in LEAD.

Connect with Internal Systems
Activities (minor tasks) can be tagged to GL accounts and payments in the administration panel.

SOURCE simplifies milestone management allowing teams to model outcomes faster and with greater accuracy.

Impact analyses in SOURCE are automated with the push of a button, savings outsourcing team time, mitigating risks, and improving overall due diligence results.

One of the most challenging aspects of bid due diligence is comparing side-by-side budget line items for activities required in the clinical study execution. This is further complicated with bid grids with > 100-line items, unstandardized bid grids or standardized bid grids that require mapping by the service provider to Sponsor templates. During bid revisions, when multiple bids grids are submitted for a single proposal, the need to compare the impact of different bid scenarios is even greater.

In SOURCE, Sponsors have access to multiple bidding choices to enhance the bid analysis and revision process:

Change analyses can be executed on “Bid to Expertise” and “Flexible Bid Grid” modes so Sponsors and Service Providers can easily spot and analyze variances from the RFP and change order specifications:

  • Identify what assumptions have changed, e.g., Sponsor proposed a country for the study, CRO proposed a different country mix.
  • Identify which activities were modified (added, deleted) by the vendor and the associated budget.

Impact analyses refer to variance comparisons between current and historical proposals by the same or different RFP participants. SOURCE permits deep diving at the most granular cost driver for clinical activities:

  • Comparison of budgets across vendors, across proposals.
  • Identification of variance drivers: number of units, number of hours, blended rates.
  • Identification of differences in allocated resources for each activity in “Bid to Resources” mode.
  • Identification of variances between original contract and proposed change order(s).
  • Determining if agreed rate cards have been applied to the project.
  • Determining if fixed unit templates have been correctly applied to the proposal.

Preferred Service Provider management takes on a whole new meaning when impact analyses can be easily extended to verify if established agreements are enforced (negotiated rates, fixed units, effort ranges). 

SOURCE makes change orders effortless allowing procurement teams to increase objectivity in the due diligence process and expedite the contract approval.

Tracking Change Orders against initial contract, various “rebids” of change orders, and multiple change orders over time is a time-consuming activity requiring data extraction and manipulation, often from different Excel-based budgets. R&D procurement teams need to be informed of changes, analyze variances, and evaluate the merit of those changes to deliver solid assessment reports leading to contract modification and approval. Out-of-scope activities are recorded in multiple trackers and CNFs (Change Notification Forms), sometimes by the Sponsors, in other cases by the Service Providers. Significant attention must be dedicated to incorporating out-of-scopes in the change order process.

In conjunction with Clinical Maestro LEAD, SOURCE makes incorporating approved change of scope seamless:

Out-of-Scope Tracking
Out of scope tracker is maintained by the service provider in LEAD. In absence of LEAD, the Service Provider can incorporate approved out-of-scope in the change order, directly in the proposal.

Approved out-of-scopes are incorporated into the change order.

Change Order Traceability
Change Orders can be initiated either by Sponsor or Service Provider.

Smart Impact Analysis
The change order bid is submitted through SOURCE for enhanced analyses. This gives the Sponsor the ability to:

  • Easily compare summary variances vs. contract or previous change order.
  • Conduct in depth analyses at minor task level to compare unit cost, unit hours, changes in rates or effort.
  • Compare at granular level any changes in assumptions or cost drivers.
  • Post in-line comments and request revisions of budget or assumptions.

With no central repository, industry experts don’t have traceability across proposal stages, from initial award and contract to subsequent tracking of CNFs and Change Orders. Clinical Maestro provides full traceability through all contract stages with SOURCE.

With SOURCE, historical proposals become actionable and the intelligence is instantly brought in the negotiation process so that proposal evaluators can spend their time focusing on the task at hand — carefully reviewing and appraising responses.

Comparing bids at proposal level across multiple bidders and bid revisions is key to successful due diligence. However, for comparable bids and strategic partner bid performance analyses, limiting the comparisons to the specific study bids does not reveal any insights to synergies that might be achieved from repeated bidding. Historical bids are often saved in company folders as Excel workbooks that are not easy to find, align, and compare, especially in absence of standardization.

SOURCE eliminates the effort of searching for historical bids and struggling through tedious Excel-based budget and assumption comparisons:

Build complex, more effective RFPs quickly
Easily identify comparable proposals by searching your bid database by preferred criteria, such as therapeutic area, study phase, vendor name or Service Provider.

Collect and evaluate quality responses
Select the bids you want to compare and align them side by side at a push of a button. Highlight min-max differences or variance ranges.

Improve strategic buying decisions
Equip yourself with the information required to negotiate effectively.

SOURCE focuses on the key components of clinical outsourcing though analytics. You can easily find and analyze proposals from your powerful bid database, giving outsourcing teams confidence that they selected the right clinical study partners.


Why do you need Clinical Maestro?

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The experts at Strategikon developed Clinical Maestro out of a combination of love and frustration. The system was developed and nurtured by financial and clinical business operations executives with both Sponsor and Provider experience. Our founders believed there had to be a better way — and so they created one.

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