Strategikon Pharma: Synchronizing a Clinical Study

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Anca Copaescu, Founder & CEO
“No one can whistle a symphony. It takes a whole orchestra to play it.” This inspirational quote by Halford E. Luccock, a prominent American Methodist minister and academician, perfectly illustrates the significance of a collaborated effort in engineering a masterpiece. Influenced by the same notion, California-based Strategikon Pharma, a leading-edge pharma tech company, built its end-to-end cloud-based platform, Clinical Maestro, coalescing all the key processes for planning a clinical study—clinical trial budgeting, sourcing, and outsourcing management—into a more streamlined experience.

“The development and execution of a clinical trial involve collaboration between sponsors—biotechs and pharmaceutical companies developing a drug—and CROs,” says Anca Copaescu, founder and CEO of Strategikon Pharma. Frustrated by the lack of tools available to efficiently plan, initiate, and manage complex clinical contracts, Copaescu founded Strategikon Pharma in 2017. “Ninety percent of the clinical study planning and outsourcing is manual, involving tremendous effort with limited accuracy,” adds Copaescu. With Clinical Maestro, sponsors and providers alike gain the ability to instill transparency in communication, drive seamless collaboration, and achieve effective results from a clinical trial. At the same time, Clinical Maestro enables customers to clearly define and execute flexible strategies that address the industry’s long-standing challenges pertaining to clinical trial management. Apart from bringing transparency to clinical studies, the quality of a pre-outsourcing plan is paramount for the delivery of an effective clinical outsourcing process. Strategikon Pharma, therefore, offers an effective framework for RFP processing with Clinical Maestro’s ‘PORTFOLIO’ component and facilitates the planning and management of scenario-based RFPs. At the same time, the ‘SOURCE’ capability of the platform allows researchers to efficiently transfer information from the pre-outsourcing plan into the RFP process. “Our software enables sponsors to digitally control the entire outsourcing process management by automatically moving the clinical study assumptions into a digital RFP template,” explains Copaescu.
On the other hand, to optimize CRO bidding processes, Clinical Maestro has two primary settings, i.e. bid-to-spec and bid-to-expertise. As the name suggests, bid-to-spec allows bidding based on the specification provided by the sponsor, and alternatively, bid-to-expertise leverages the CRO’s experience in the creation of bids. After the completion of an RFP, Clinical Maestro communicates directly with preferred partners to improve tracking and auditability versus email.

For sponsors, Clinical Maestro captures the submission of RFP answers in a digital format, driving efficiency into the due diligence that follows the processing of RFPs. “Today, the entire outsourcing journey can be completed without exchanging one piece of paper; the selection history and decision making process are captured by the system for inspection readiness and future data mining,” opines Copaescu.

Clinical Maestro enhances the CRO bidding journey, enhancing the multi-sponsor management, bid comparison and analyses, building qualification databases and inmbuing efficiency into Sponsor interactions. “Most pharmaceutical companies today, use “standardized” bid grids. However, each “standard” is unique to the sponsor, so in fact, there is no standard at all. This causes CROs to spend significant numbers of hours mapping sponsor-specific internal bid grids, which often results in mapping errors and makes the contracts challenging to track,” says Copaescu. With Clinical Maestro’s new digital standard, the CROs can better align themselves with Sponsors’ expectations to achieve tremendous cost savings and differentiation. As a result, less time is spent in deciphering cost and more on understanding execution strategy and excellence. All these processes taken together, “Strategikon Pharma’s Clinical Maestro platform drives operational excellence in the overall clinical outsourcing process,” states Copaescu. At the core of Strategikon Pharma’s ethos is delivering a solution that finally allows sponsors and CROs to overcome the age-old obstacles in clinical outsourcing in a new and transformative manner. Looking ahead, Strategikon will drive innovation within the clinical trial infrastructure by consolidating the entire intelligence engine behind the outsourcing of clinical processes. “We are focused on offering efficiency, transparency, better go-to-market time, and cost savings while striving to spur the industry’s adoption of modern clinical tools and data,” concludes Copaescu.

Company
Strategikon Pharma

Headquarters
San Rafael, CA

Management
Anca Copaescu, Founder & CEO

Description
The development and execution of a clinical trial involves collaboration between sponsors—which can be individuals or pharmaceutical companies developing a drug—and CROs. However, the siloed operations and lack of an avenue to bridge the gap between the two entities is introducing inefficiencies into trial performance. In order to address this challenge and break down the walls between CROs and sponsors, Strategikon Pharma has developed Clinical Maestro. With this product, Strategikon Pharma delivers a novel, faster, and more accurate way to plan, model, and manage clinical trials

Strategikon Pharma