KLARA – AI-Enabled Source Data Verification Service for Clinical Trials

Pricing & Engagement Duration: KLARA is offered as a Hexaware professional services engagement on AWS. Scope typically includes an assessment and onboarding phase to configure study-specific document types, EDC integrations, and the canonical clinical data model, followed by ongoing SDV service delivery. Pricing is provided through AWS Marketplace on a professional-services basis (fixed-price or milestone/time-based, scoped per sponsor/CRO study portfolio); final pricing and engagement duration are confirmed during scoping. (Note: exact pricing and engagement duration were not specified in the source document and should be confirmed by Hexaware prior to publishing.)

Overview: KLARA is Hexaware's AI-enabled Source Data Verification service designed specifically for the clinical trials industry. Source Data Verification remains one of the most effort-intensive and costly activities in clinical trial monitoring. Manual SDV increases CRA (Clinical Research Associate) workload, creates variability in review quality, slows discrepancy identification, and limits the scalability of remote monitoring. Delivered as a professional services engagement, KLARA automates and accelerates the traditional manual process of comparing clinical source documents against data entered in Electronic Data Capture (EDC) systems, delivering evidence-backed results that improve speed, consistency, and inspection readiness.

Service Scope & Key Capabilities:

• Assessment & onboarding: Hexaware configures study-specific document types, EDC integrations, and the canonical clinical data model.
• Multi-document ingestion: Processes clinical notes, lab reports, informed consent forms, vital signs records, imaging reports, and discharge summaries.
• AI-driven extraction pipeline: OCR, AI-based document classification, clinical data extraction, source-to-EDC linkage, and field-level comparison.
• EDC data integration & standardization: EDC data imported via ODM XML, CSV, JSON, or API-based integrations and standardized through a canonical clinical data model.
• Evidence-backed SDV results: Field-level comparison outputs with linked source evidence for reliable CRA review.
• Audit-trailed review dashboard: CRA users confirm results, override AI outputs, or raise queries within a fully traceable workflow.
• Expert delivery: Engagement led by Hexaware's Life Sciences & Healthcare domain specialists.

Benefits:

• Reduces manual SDV review effort and CRA workload.

• Improves consistency and quality of source verification across studies.

• Enables scalable, remote SDV for decentralized and hybrid trial models.

• Increases inspection readiness through evidence-linked, audit-trailed records.

• Accelerates identification of source-to-EDC discrepancies.

Expected Outcomes:

• Faster SDV cycles and reduced monitoring cost per study.
• More consistent, higher-quality review with less reviewer variability.
• Greater scalability of remote monitoring across a study portfolio.
• Improved regulatory inspection readiness with traceable, evidence-backed audit trails.

Key AWS Resources Used: Here are the key AWS resources grouped by their primary function:

1. Networking & Content Delivery

• Amazon Route 53 (DNS)
• Amazon CloudFront
• Amazon VPC (Virtual Private Cloud)
• Application Load Balancer

2. Security & Identity

• AWS Certificate Manager / ACM (TLS Certificates)
• AWS WAF (Web Application Firewall)
• Amazon Cognito (Authentication)
• AWS IAM (Identity and Access Management Roles)
• AWS Secrets Manager

3. Compute & Scaling

• Amazon ECS on AWS Fargate (Backend and Workers)
• AWS Auto Scaling

4. Storage & Data Transfer

• Amazon S3 (Used for both Frontend Static Files and Data Lake Storage)
• AWS Transfer Family (SFTP Connector)

5. Databases & Caching

• Amazon RDS (PostgreSQL)
• Amazon ElastiCache (Redis)

6. Artificial Intelligence & Monitoring

• Amazon Bedrock (Generative AI)

• Amazon CloudWatch (Monitoring & Logs)

Delivery: Primary execution and delivery is led by Hexaware teams in India with Life Sciences & Healthcare domain expertise. Target commercialization is global, with initial focus on regulated clinical trial markets including the United States, European Union, United Kingdom, and other sponsor/CRO operating regions.