AB Cube Germany, a leading provider of eClinical software and the developer of the Marvin EDC platform today announced the upcoming launch of Marvin Study Designer, an AI-assisted application that enables clinical data managers to generate complete, standards-compliant study definitions in minutes from a simple study description or an uploaded protocol. Designed as a companion to the Marvin EDC platform, the solution helps accelerate one of the most time-consuming phases of clinical trial startup while ensuring experts remain fully in control.
Marvin Study Designer generates complete study structures including visits, forms, fields, controlled terminology, and validation rules from plain-language prompts or protocol documents. Every draft is informed by a knowledge base of more than 840 real CDISC ODM study definitions, producing review-ready designs that follow proven clinical data management practices rather than relying on AI-generated assumptions.
In contrast to other cloud-based AI solutions, Marvin Study Designer runs entirely within our own infrastructure. No study protocols, patient data, or other sensitive information are sent to external data processors, making it well suited for organizations with strict security and compliance requirements.
The application is built around a human-in-the-loop approach: AI creates the initial draft, while clinical experts review and approve every element before deployment. A built-in validation engine checks each study against Marvin's import schema and business rules, helping ensure consistency, quality, and compliance before publication.
Beyond study design, Marvin Study Designer can automatically generate edit checks, synthetic patient data, and test users to support faster study validation and testing before go-live.
"Marvin Study Designer combines the speed of AI with the oversight required for regulated clinical research," said Manuel Neukum, CEO of AB Cube Germany. "It enables clinical teams to reduce manual effort, accelerate study startup, and confidently use AI without compromising data security or quality."
To learn more or request a demonstration, visit www.marvin.now.
Marvin Study Designer generates complete study structures including visits, forms, fields, controlled terminology, and validation rules from plain-language prompts or protocol documents. Every draft is informed by a knowledge base of more than 840 real CDISC ODM study definitions, producing review-ready designs that follow proven clinical data management practices rather than relying on AI-generated assumptions.
In contrast to other cloud-based AI solutions, Marvin Study Designer runs entirely within our own infrastructure. No study protocols, patient data, or other sensitive information are sent to external data processors, making it well suited for organizations with strict security and compliance requirements.
The application is built around a human-in-the-loop approach: AI creates the initial draft, while clinical experts review and approve every element before deployment. A built-in validation engine checks each study against Marvin's import schema and business rules, helping ensure consistency, quality, and compliance before publication.
Beyond study design, Marvin Study Designer can automatically generate edit checks, synthetic patient data, and test users to support faster study validation and testing before go-live.
"Marvin Study Designer combines the speed of AI with the oversight required for regulated clinical research," said Manuel Neukum, CEO of AB Cube Germany. "It enables clinical teams to reduce manual effort, accelerate study startup, and confidently use AI without compromising data security or quality."
To learn more or request a demonstration, visit www.marvin.now.
