Comparison with Existing Commercially Available Aged Point Solutions

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End-to-End Platform for Business Operations

Clinical Maestro™ is an end-to-end platform consisting of 8 integrated applications enabling both Pharma and Provider to manage the full clinical trial lifecycle (budgeting, sourcing, financial metrics and vendor management). It is offered in a modular structure; 4 modules in the Pharma (Sponsor) Edition and 4 modules in the Provider (CRO) Edition. The modules are designed to work seamlessly for maximum efficiency but can also be used as stand-alone solutions.

While there are numerous differentiating features of Clinical Maestro™, it is its breadth that delivers the greatest organizational value over other commercially available systems. Clinical Maestro™ covers all key business operations that are required to support the outsourcing and oversight of an in-patient clinical trial.

Furthermore, it is the only tool on the market that targets both Pharma (Sponsor) organizations and Providers (CROs). This dual application approach enables digital standardization that aligns all major stakeholders. It is only by equipping both sides with equivalent powerful technology resources that we can create meaningful efficiencies and truly move the industry forward towards a greater focus on strategy and execution.

Moreover, with industry-leading substitute products having been developed over ten years ago, the modernity of Clinical Maestro™™ provides significant technology advantages to its users that are immediately obvious by comparison. These include intuitive user interfaces, dynamic and elegant visualizations, collaborative two-way communication features and simplified integrations with external legacy applications.

Finally, all the above-mentioned categories of innovation are further strengthened by eminent ROI that Clinical Maestro™™ delivers for both Pharma companies and Providers. Its price point is highly competitive with other major systems despite a massively greater span in functionality, and its flat-fee flexible pricing structure is designed to encourage utmost usage across the customer's organization, driving even greater efficiencies and savings.

Deep Dive: Comparison of Major Features & Benefits

The industry has only just begun to benefit from the latest and greatest technological advancements available today, such as digitization, automation and artificial intelligence. Commercial-grade, fit-for-purpose, well- designed new intelligent applications for the business administration of clinical trials are still few and far between. Yet, what's certain is that they will have a profound impact on what remains to be some of the most antiquated and manual processes in drug development: business operations. This creates a massive opportunity to realize savings not by changing well-established processes, but by rendering them far more efficient through modern technology.

We have therefore conducted the following analysis of the major categories of technology solution providers in the Clinical Maestro™space. These consist mostly of substitute point solutions that compete with a certain portion of the platform Clinical Maestro™ covers. Study budgeting solutions like Oracle's ClearTrial, general procurement solutions that are non-industry-specific such as Scout RFP and SAP's ARIBA, and vendor discovery and contracting engines such as Tealbook, ScienceExchange and Scientist.com to name a few.

Our analysis confirmed that there is no commercially-available solution on the market today that compares to the breadth, accuracy or specificity of Clinical Maestro™.

Study Budgeting Comparison: Additional Observations

Oracle's ClearTrial (CT) similar in functionality to our Clinical Maestro™™ PORTFOLIO application for study planning and budgeting, with the following key differences:

  • Clinical Maestro™™ provides follow-on data flows from budgeting to sourcing, financial management and vendor management (addresses the full lifecycle as opposed to just budgeting).
  • Clinical Maestro™ is built using brand-new collaborative technology enabling the Sponsor to mine its own data and improve its estimates through predictive analytics and Al.
  • Clinical Maestro™ PORTFOLIO budgeting function is highly accurate at the minor task level (>95%demonstrated in two recent case studies) as it is based on 4X more standardized tasks which are structured on effort ranges (hours and resources).
  • Clinical Maestro™ has a more user-friendly interface, so it is easier to navigate, export or import information, customize dashboards, reports and visualization.
  • Clinical Maestro™™ allows for extensive operational planning, which is separate but integrated with financial planning. Examples includes ability to model IMVS, SAES, CTA payment frequency, build SOA (schedule of events), and investigator grant cash flow.
  • Clinical Maestro™ allows for location-driven planning and budgeting, including tracking site, CTA and patient activity at country and regional level.
  • Clinical Maestro™ can accommodate complex study designs, such as protocols with multiple-patient groups (arms, cohorts) which may vary in schedule of events and / or location.
  • Clinical Maestro™ allows tracking RACI (Responsible, Accountable, Consulted, Inform) at the MINOR task level as opposed to broad categories; this supports modeling custom unique outsourcing strategy and can be customized into a TORO (Transfer or Regulatory Obligation) report.
  • Clinical Maestro™ is the only system in the industry to track and model hybrid tasks. By hybrid tasks we are referring to tasks where Sponsor and CRO frequently share responsibilities e.g. Sponsor writes protocol, CRO reviews and provides input, or locations are shared between Sponsor and CRO.
  • Clinical Maestro™ tracks and compares multiple rate cards and has the ability to instantly blend rates based on the location of the study resources.
  • Clinical Maestro™ allows for dynamic editing within a specific scenario, i.e. you do not need to create a new scenario to compare the impact of changes. In addition, the system allows for extensive impact analyses across all cost and operational dimensions.
  • Clinical Maestro™ is designed to work with all industry stakeholders by building a shared a digital standard. This delivers efficiencies on both the Pharma (Sponsor) and Provider (CRO) sides.
  • Clinical Maestro™ allows for client preference configuration and integrates with other legacy embedded systems that may already be in use within the customer environment.
  • Clinical Maestro™ is offered on an annual subscription-basis with unlimited seats and unlimited studies, and is not priced per-study which dis-incentivizes usage. Strategikon Pharma is dedicated to modernizing processes by encouraging continuous adoption of technology to move the industry forward collectively.

ROI & Delivered Savings

In addition to an improved user experience, Clinical Maestro™ differentiates itself on the basis of the return and savings it delivers. The sheer breadth and continuous nature of the system allows for the elimination of time-consuming, non-standardized document handovers between stakeholders. Meanwhile its digital inputs and database structure completely avoid frustrating version control issues and manual human-errors.

Following the results obtained in our recent industry survey, we have calculated that the Clinical Maestro™™™ single platform approach creates more than 75% effort efficiencies throughout the life-cycle of a study. [Strategikon Pharma Industry Survey 2018]

  • 75% less effort than industry average in clinical study budgeting; in addition, it saves on average 60 hours per proposal in the initial RFP due diligence (excluding scenario modeling/re-bid analyses).
  • 60-85% less effort than industry in RFP/Proposal Management (creating and managing an RFP, excluding budget due diligence) saves on average 100 hours per full-service RFP and 60 hours per non- CRO RFP.

Taking into account the number and level of FTE knowledge workers that contribute to clinical trial business operations at a typical mid-sized Pharma (Sponsor) organization, this translates into more than $300,000 USD of annual savings per outsourced clinical trial.

  • Assumption: 2 aggregated FTEs + negotiated savings through greater bid transparency
  • 75% outsourcing manager role
  • 10% outsourcing leader role
  • 50% finance person role
  • 25% vendor management role
  • 15% project manager role
  •  5% senior clinical person
  • 20% of clinical operations role

Assuming the purchase of a full service Clinical Maestro™™ Pharma Edition annual subscription (PORTFOLIO, SOURCE, LEAD, VISION modules), the average price of the an organizational access license is less than $50,000 USD per study.

This results in a return-on-investment of 600%, indicating that the savings realized through the utilization of Clinical Maestro™™ significantly exceeds the acquisition cost of the system.

Conclusion

In conclusion, Clinical Maestro™ was designed for complex transactions and follow-on financial performance metrics specific to clinical trials. It is a best-in-class tool for pharmaceutical and biotech professionals to collaborate on planning and performance beyond just the procurement function. It provides workflows and efficiencies horizontally across drug development companies, with Clinical Operations, Finance R&D, Outsourcing/Procurement, Project Management and Providers all benefiting in unison.

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