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Smart Study Design: AI-Driven Protocol Analysis & Feasibility

Consulting Virtual
Unique Identifier: 8c0c92b8-407a-4987-bb21-fdb83da1c83b

Service Description

Who Can Benefit: - Clinical Researchers and Study Designers: For leveraging AI capabilities to refine and finalize study protocols, enhancing their effectiveness and feasibility. - Medical Product Developers: To assess the clinical viability of new products and solutions, ensuring they meet necessary evaluation criteria before market introduction. - Research and Development Teams: For innovative project development utilizing cutting-edge AI technologies to optimize research outcomes.

Key Features: - AI-Driven Protocol Parsing: Leverages artificial intelligence to automatically parse, structure, and analyze clinical study protocols, extracting key parameters and identifying inconsistencies or gaps. - Feasibility Assessment: Conducts detailed evaluations to determine the viability of clinical studies for medical products, ensuring alignment with research goals and regulatory standards. - Design Optimization Recommendations: Generates actionable suggestions for protocol refinement – from endpoint selection and visit schedules to sample size considerations and risk mitigation. - Regulatory Alignment Check: Automatically flags protocol elements that may conflict with applicable standards (ISO 14155, MDR, ICH-GCP) or require additional justification. - Expert-in-the-Loop Guidance: Combines AI-generated insights with human expert review from clinical and technical specialists to deliver validated, trustworthy recommendations.

Applications: - Study Protocol Evaluation: Employs AI technologies to enhance the accuracy and efficiency of protocol assessments, identifying potential challenges or areas for improvement. - Clinical Feasibility Analysis: Provides critical insights into the practicality of proposed research projects, aiding in the decision-making process for medical product development. - AI-Enhanced Clinical Research: Supports the integration of AI tools to streamline clinical study planning and execution.

Who we are: The Fraunhofer IIS has established the Center for Sensor Technology and Digital Medicine in cooperation with the University Hospital Erlangen and the University of Erlangen-Nuremberg to enhance healthcare efficiency through sensors and digital solutions. This center focuses on integrating innovative medical technologies like patient-specific therapies, digital health applications, medical diagnostics via wearables, and robotic systems for care. Located at the University Hospital Erlangen, it offers unique infrastructures for the development, integration, and validation of novel health technologies, providing companies opportunities for technological advancements. For more information, visit the Fraunhofer IIS website.

Keywords: Clinical Evaluation RAG technical documentation Scietific-Technical Constulting Agentic AI
Offerings: Research & Development Technological Solutions & Documentation Scientific & Medical Communication Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)
Provider Country Germany
Published Email dhs-studien@iis.fraunhofer.de

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs - Study Protocol (Draft or Final) - Product Documentation - Intended Clinical Test Centers - Resource Constraints and Strategic Objectives
Service Outputs - Parsed Protocol Summary as Basis for CIP - Feasibility Assessment Report - Gap & Inconsistency Analysis - Optimization Recommendations
Comments - The service is designed as a rapid, low-barrier entry point for organizations seeking clarity on whether a clinical study concept is worth pursuing – typical turnaround for an initial assessment is a few weeks depending on protocol complexity. - Human expert review ensures that AI outputs are clinically grounded, contextually appropriate, and free of hallucination artifacts.

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