2024

Prodigy

Entrant Company

Clarity Quest

Category

Achievement of the Year - Leader in Innovation

Client's Name

ProPharma

Country / Region

United States

Prodigy is a suite of AI and advanced automation applications that solve for productivity challenges that drive delays and cost throughout the pharmaceutical and medical device development lifecycle. By developing discrete applications that solve for manually intensive activities across regulatory, medical and clinical operations, we have effectively removed lifecycle delays, de-risked program delivery, shortened time-to-insight and enhanced the overall medicinal value of our clients’ assets.



Prodigy represents a milestone in the application of AI and machine learning to solve specific operational challenges in the conduct of product development. We focus on specific use cases that would make a meaningful impact to our clients as well as our global employee base including automated patient narrative writing, AI-enabled document QC, AI-enabled regulatory intelligence and visualizations. This has further included bringing a Llama-2, an open-source large language model, in-house to ensure optimal security of relevant data and building an easy-to-use front end to streamline source document and source data ingestion. Guiding our design and build effort has been our goal to: “Create and enhance the value of every idea, molecule and therapy across all of our client’s operations, from discovery to development to commercialization; driving productivity and the deepest understanding of disease, biology, modality/technology from bench to bedside.”



Our design includes the following applications:

• Prodigy Narrative: Automated tool that develops high quality patient narratives and profiles in minutes

• Prodigy QC: Reduce manual effort in QC’ing any document against source data (e.g. data within a CST and alignment with protocol)

• Prodigy Privacy: Anonymous & redaction software for sharing clinical data and documents with Health Authorities, partners

• Prodigy Live: Real-time clinical data visualization tool that can roll-up to the program-level. Based on SDTM data

• Prodigy Feasibility: Data-driven feasibility dashboard that integrates patient claims, investigator & site data, clinical trial performance data, prevalence and other real-world evidence to de-risk country and site selection

• Prodigy Label: Automated label intelligence tool: review, compare and export incumbent labels by section, in seconds

• Prodigy Approvals: Rapidly review, select and extract summary basis of approval comments & insights from the FDA to inform new product planning

Credits

Chief Strategy Officer
Bryan Katz
Lead Developer
Eric Hauk
Data Engineer
Steve Wilson
UX Designer
Andy Herman
Project Manager
Earon Sotto
EVP, Regulatory Sciences (SME)
Tracy Rockney
Head of Biostatistics (SME)
Bobbie Rachford
Sr. Director, Corporate Operations (Visualizations SME)
Bridget Bell
Chief Marketing Officer
Zosya Popik
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