Clinical outcome assessment (COA) interviews are important instruments in clinical trials for evaluating the efficacy and safety of treatments. In studies of psychosis, anxiety, and mood disorders, these assessments often determine the success or failure of the trial, highlighting the importance of data quality and reliability. The traditional approach to evaluating the quality of these outcomes is complex and involves time-consuming, logistically challenging reviews of audio-video recordings in near real time. Interview evaluation variability, poor assessment technique, and other factors can introduce noise, leading to unreliable results and potentially to study failure.

About Clario

Clario is a leading provider of endpoint data solutions for systematic collection, management, and analysis of specific, pre-defined outcomes (endpoints) to evaluate a treatment’s safety and effectiveness in the clinical trials industry. Clario generates high-quality clinical evidence for life sciences companies seeking to bring new therapies to patients. Since its founding over 50 years ago, Clario has deployed endpoint data solutions over 30,000 times, supporting over 710 novel drug regulatory approvals across more than 100 countries.

In this post, we demonstrate how Clario has used Amazon Bedrock and other AWS services to build an AI-powered solution that automates and improves the analysis of COA interviews. We discuss how Clario:

• implemented speaker diarization, multi-lingual transcription, and large language models (LLMs)
• used vector databases and semantic search to evaluate interview quality
• incorporated automation into complex assessment reviews while maintaining regulatory compliance

Business challenge

Clario sought to transform their COA review methodology to enhance operational effectiveness while also increasing data quality. The company required a system that could address the critical challenges of standardized review of multi-lingual data at a global scale, while reducing natural variation between different expert reviewers, and maintaining uniform assessment quality across the complex COA interview process. The solution also needed to efficiently manage large volumes of audio recordings while meeting strict regulatory and privacy requirements. Clario sought capabilities that could automatically analyze speech and dialogue in near real time during COA interviews to potentially enable:

• Reduced subjectivity and variability – Delivering more consistent and reliable behavioral health assessments, minimizing site and rater bias.
• Enhanced data quality and credibility – Improving the robustness of trial outcomes with objective, standardized, and repeatable interview evaluations.
• Streamlined operations – Automated complex assessment review and scoring could save time and resources for geographically dispersed sites and sponsor-level clinical teams.
• Accelerated decision-making – Gaining clearer insights earlier could support faster, evidence-based go or no-go decisions for the trial sponsors.

Solution

To address this challenge, Clario chose AWS for its comprehensive artificial intelligence and machine learning (AI/ML) capabilities, proven ability to deploy HIPAA-compliant services at a global scale. Clario used the power of generative AI and Amazon Bedrock, a fully managed service that provides access to a diverse range of high-performing foundation models, to offer several key advantages:

• No infrastructure management – Alleviate the operational overhead of managing AI model infrastructure and updates
• Multiple model access – Compare and select from leading foundation models to optimize performance for their specific COA analysis needs
• Built-in compliance features – Native support for data governance, audit trails, and regulatory requirements essential for clinical research
• Rapid prototyping and deployment – Accelerated time-to-market through serverless architecture and pre-built integrations
• Seamless AWS system integration – Native compatibility with existing AWS services for data storage, processing, and analytics
• Enterprise security and privacy controls – Advanced encryption, access controls, and data residency options to help meet stringent industry standards
• Continuous model improvements – Automatic access to model updates and new capabilities, reducing migration complexity

This comprehensive approach enabled Clario to focus on their core competency—clinical research excellence—while using cutting-edge AI capabilities through a trusted, compliance-aligned system.

The solution integrates advanced AI capabilities, including speaker diarization, multi-lingual transcription, semantic search, and agentic AI, to automatically review the quality of complex COA interviews in a manner similar to expert human central reviewers. The workflow orchestrates multiple steps where audio data is first analyzed to identify the unique speakers in the interview based on their voice, followed by speech-to-text conversion, and speaker role attribution to determine which speech corresponds to the interviewer and the study participant.

This information is segmented into semantically meaningful chunks based on speaker turns and natural conversation boundaries, with each segment maintaining crucial metadata. Examples of metadata include timestamps, speaker role, and positional context. These chunks are then vectorized and stored in an Amazon OpenSearch vector database, enabling the system to overcome the context window limitations of foundation models when processing lengthy interviews. The solution implements a sophisticated retrieval strategy where:

• Overlapping windows makes sure that contextual information is not lost at segment boundaries
• Targeted semantic searches identify specific dialogue segments relevant to each assessment criterion
• A hierarchical approach preserves both local conversational flow and global interview context through interview-level summaries and speaker roles
• Rolling context windows can be dynamically assembled when evaluating criteria that span multiple segments

This architecture allows the system to efficiently handle multiple queries against the same interview data while maintaining contextual relationships throughout the conversation. The system uses this semantic retrieval capability to analyze the content of the dialogue between the interviewer and the participant, evaluating it against a structured interview guide and central review checklist. The output of the workflow includes a quality rating for the interview, along with structured feedback for each checklist item, specifying where the interview diverges from the established standards. The overall system provides near real-time insights into the quality and reliability of the COA interview, supporting faster evidence-based go or no-go decisions for sponsors of clinical trials.

Solution architecture

The following architecture diagram illustrates the solution implementation:

The workflow consists of the following steps:

• The COA interview recordings (audio and video files) from the interviews are collected on premises (1) using a recording application. The files are uploaded using AWS Direct Connect with encryption in transit to Amazon Simple Storage Service (Amazon S3)(2). The uploaded documents are then automatically stored with server-side object-level encryption.
• After the files are uploaded, Clario’s AI Orchestration Engine (3) extracts the audio and identifies speech segments of unique speakers using a custom speaker diarization model on Amazon SageMaker (4).
• The Orchestration Engine also invokes the Amazon Bedrock API for automated audio transcription. Clario uses the Whisper model from the Amazon Bedrock Marketplace (5) to generate near real-time transcriptions of the COA interview recordings. The transcriptions are then annotated with speaker information and timecodes, and then vectorized using an embedding model (Amazon Titan Text Embeddings v2 model) and stored into Amazon OpenSearch (7) for semantic retrieval.
• After the information has been vectorized and stored, Clario’s AI Orchestration Engine executes a graph-based agent system running on Amazon Elastic Kubernetes Service (Amazon EKS)(3) for automated COA interview review. The agent implements a multi-step workflow that: (1) retrieves the assessment’s structured interview guide from configuration, (2) loads the corresponding central review checklist criteria, and (3) systematically queries Amazon OpenSearch (7) to extract relevant interview segments. Using the pre-configured graph structure for the task at hand, the agent traverses predefined decision nodes to compare interview responses against standardized assessment criteria, identify gaps or inconsistencies, and generate structured findings with supporting evidence citations.
• The agent uses advanced large language models (LLMs), such as Anthropic Claude 3.7 Sonnet from Amazon Bedrock (6), to classify the speech segment as interviewer or participant, and to determine if each interview turn meets the interview quality criteria.
• Clario’s AI Orchestration Engine then compiles the overall review of the interview and persists the information in Amazon Relational Database Service (Amazon RDS)(8).
• Results of the AI-powered automated review can be retrieved by a client application (9) by invoking a Rest API using Amazon API Gateway endpoints (10).

Benefits and results

The initial implementation of this AI-powered solution is showing promise in improving Clario’s clinical trial processes:

• Operational efficiency

• Potential to decrease manual review effort by over 90%.

• Quality improvements

• Up to 100% data coverage through automated review versus human-only review of a smaller subset of recordings to spot check quality.

• Highly targeted interventions might be enabled with rapid turnaround, focusing only on those raters and sites that require remediation.

• Business impact

• Potential to shorten turn-around time by decreasing central review time from weeks to hours.

• Enhanced data reliability for regulatory submissions.

• Reduced risk of study failure and uninterpretable results.

• Improved scalability of clinical trial operations.

Lessons learned and best practices

Throughout the development and deployment of this solution, Clario has gained valuable insights and lessons learned that can benefit other organizations looking to implement similar AI-powered systems:

1. Importance of responsible AI development and use – During initial testing, Clario discovered that LLMs would occasionally generate plausible sounding but inaccurate summaries. This critical finding reinforced the importance of responsible AI practices in healthcare applications. This led Clario to implement a validation system where AI outputs are cross-checked against source documents for factual accuracy before human review.
2. Continuous model evaluation – Clario adopted a rigorous model evaluation process to maintain the highest standards of quality and reliability in their AI-powered COA interview analysis solution. Clario regularly assessed the performance and accuracy of their AI models through multiple approaches, including comparative studies on custom datasets, across multiple models and configurations.
3. Scalable and more secure architecture – The serverless, cloud-based architecture of the solution–using services like Amazon Bedrock, Amazon S3, and AWS Lambda–helped Clario to scale their solution effectively while prioritizing data security and compliance.

Next steps and conclusion

Clario’s innovative solution has the potential to transform the way COAs are reviewed and rated, significantly improving the reliability of clinical trial data and reducing the time and effort required for manual review. As Clario continues to refine and expand the capabilities of this AI-powered system, Clario is exploring additional use cases in neuroscience studies that rely on clinical interviews for evaluating the safety and efficacy of treatments.

By using generative AI and the robust features of Amazon Bedrock, Clario has set a new standard for clinical trial data analysis. This empowers their customers to make more informed decisions and accelerate the development of life-changing therapies.

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About the authors

Alex Boudreau is the Director of AI at Clario. He leads the company’s innovative Generative AI department and oversees the development of the company’s advanced multi-modal GenAI Platform, which encompasses cutting-edge cloud engineering, AI engineering, and foundational AI research. Alex previously pioneered Deep Learning speech analysis systems for automotive applications, led cloud-based enterprise fraud detection solutions, advanced conversational AI technologies, and groundbreaking projects in medical image analysis. His expertise in leading high-impact initiatives positions him uniquely to drive forward the boundaries of AI technology in the business world.

Cuong Lai is the Technical Team Lead for the Generative AI team at Clario, where he helps to drive the development and scaling of the company’s generative AI platform. With over eight years of software engineering experience, he specializes in web development, API design, and architecting cloud-native solutions. Cuong has extensive experience leveraging AWS services to build secure, reliable, and high-performance systems that support large-scale AI workloads. He is passionate about advancing generative AI technologies and delivering innovative, production-ready AI solutions.

Praveen Haranahalli is a Senior Solutions Architect at Amazon Web Services (AWS), where he architects secure, scalable cloud solutions and provides strategic guidance to diverse enterprise customers. With nearly two decades of IT experience, Praveen has delivered transformative implementations across multiple industries. As a trusted technical advisor, he partners with customers to implement robust DevSecOps pipelines, establish comprehensive security guardrails, and develop innovative AI/ML solutions. He is passionate about solving complex business challenges through cutting-edge cloud architectures and empowering organizations to achieve successful digital transformations powered by artificial intelligence and machine learning.