Driving Speed and Negotiated Savings

CLIENT:

A West coast area-based Biotech company.

STUDY DESCRIPTION:

Phase 2 respiratory study

• 1 Regional CRO

• 300 Patients

• 9 Countries

When planning their new Phase II respiratory study, a West coast area-based Biotech was determined to avoid the pain they experienced outsourcing their previous clinical trial, which was similar in size and scope. With Clinical Maestro, they were able to do just that.

PLAN and BUDGET

The Sponsor agreed to apply technology to create financial study models using industry benchmarks and conduct outsourcing using RFP automation. They used out-of-box PORTFOLIO and SOURCE applications and set up their study model and RFP directly in the system.

INITIATE RFP

Client created an electronic RFP from within the SOURCE Application. Bidders (CROs) were set-up in the VISION application for bid and contract management.

BID to CONTRACT

Using SOURCE, eight CROS were invited to "bid-to-spec" and "bid-to-expertise" scenarios in Clinical Maestro™™. The Biotech used the system to conduct thorough due diligence on the CRO bids.

In that prior experience, they did not have a sense of what a fair budget should be and relied heavily on the CRO. Negotiations were a struggle and seven months post-RFP, they still did not have a finalized budget or contract.

When they were ready to outsource the next study in their pipeline, the Sponsor, on the advice of industry-veterans, agreed to try something new: applying technology to create financial study models using industry benchmarks and conducting outsourcing using RFP automation. They acquired a license to Strategikon Pharma's Clinical Maestro® platform, using out-of-box PORTFOLIO and SOURCE applications, and set up their study model and RFP directly in the system. The system set-up, team onboarding and training, and the initial activities were completed in about 3 weeks.

After creating a few different study scenarios, the Sponsor's internal team settled on a primary baseline budget of approximately $10.3M in direct costs using the Clinical Maestro Fair Market Value.

"We felt more prepared than ever going into bid defense. Because of the effortless level of due diligence provided by Clinical Maestro, we were able to comprehensively analyze each bid and formulate pertinent, pointed questions for each CRO. This increased the value and impact of the bid defense experience as a Sponsor." -Head of Clinical Operations US

The Sponsor sent the RFP out requesting two bids back: a "bid-to-spec" scenario and a "bid-to- expertise" scenario. These two methods were easily accommodated in the system and were conducted in parallel as part of the outsourcing strategy: to gain insights from the CROS expertise and apply pricing pressure on apple-to-apple standardized assumptions.

The results were impressive; the incoming budgets ranged between $7.9M and $13.8M for the bid- to-spec, with the Clinical Maestro estimate coming in around the middle of the pack, as depicted in the graph below.

For the bid-to-expertise responses, Clinical Maestro's side-by-side automated comparison clearly depicted changes that CROs had made to the assumptions, making these alternative clinical strategies, along with the CRO's experience to deliver them successfully, insightful to consider. The Biotech used the system to conduct thorough due diligence on the CRO bids. Using the Clinical Maestro SOURCE module, they compared each bid to the study model they had created in PORTFOLIO, and to the CRO bids.

Four CROs were invited to a bid defense. The ability of the system to deliver detailed, straightforward bid comparisons delivered an added, unexpected benefit of helping the biotech prepare for the bid defense exercise.

Following the bid defense, the biotech was able to select a winner immediately. The winning CRO was provided a rebid 3 weeks later based on changing parameters in the study plan. Using benchmark costs provided by Clinical Maestro, the Biotech focused on negotiation, finalizing the budget 5 weeks later.

Numerous benefits were realized by the Biotech company by using Clinical Maestro for outsourcing their Phase II study.

An estimated $800,000 in direct costs were saved through more effective negotiation.

• With clear and consistent study assumptions, the CROs knew their tasks and assigned appropriate resources for tasks they were responsible for. This transparency between Sponsor and CRO, combined with an industry benchmark from Clinical Maestro, enabled effective negotiations and resulting savings.

The outsourcing process was completed at least 2 months sooner.

• Clinical Maestro SOURCE expedited the Biotech's ability to conduct due diligence assessments across multiple dimensions for each of the bidding CROS. The system eliminated much of the time normally required to prepare the data for analysis, allowing them to jump to value-added activities such as analysis, interpretation, and fast decision-making.

• From a macro-view, reducing the contract period by four months for each trial in the pipeline could enable the Biotech to speed the entire pipeline, reach the market faster, and generate significant value for the organization.

"The savings we were able to negotiate using Clinical Maestro's industry benchmarks helped us recoup over 25X our investment in just 4 months."-Biotech Head of Clinical Operations US

Rapid Time-to-Value by Leveraging an Experienced Super-User

• As their outsourcing consultant was an experienced Clinical Maestro system operator, the Biotech was able to accelerate onboarding and quickly realize a significant return on their technology investment.

Clear and Impressive Presentation of Data-Driven Decisions to Senior Leadership

• Using Clinical Maestro, the Biotech achieved a better understanding of the study's cost drivers, an expedited outsourcing process, confidence around Fair Market Value, and CRO comparability. Additionally, Clinical Maestro enabled the Biotech's clinical operations leaders to assemble an impressive, crisp presentation of the data supporting their selection decision.

"Clinical Maestro's elegant Ul has many options to export tables, charts, and comparisons as PDF, PNG, or excel files. These can be easily dropped into a presentation for sharing, making socializing the value of the tool a cinch." - Biotech Outsourcing Consultant

In comparison with their previous study, which was similar in size and scope and sourced using traditional, manual methods, the entire outsourcing process from RFP to final budget was 2X faster using Clinical Maestro, saving the organization 4 months.

In conclusion, the Biotech realized strong value and return on their technology investment with Clinical Maestro, and will continue to use the technology for their next three studies planned in their pipeline.