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Clinical Trial Solutions

Accelerating research through intelligence, automation, and compliance

Clinical Trial Solutions

Calance brings the power of artificial intelligence, predictive analytics, and automation to clinical research. Our AI-Powered Clinical Trial Solutions are built to improve efficiency, accuracy, and compliance across key stages of the clinical development lifecycle—from protocol design to patient recruitment and ongoing regulatory adherence.

Using natural language processing, large language models, and advanced data analytics, we help life sciences organizations make data-driven decisions that optimize resources, and bring therapies to patients more efficiently.

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The Challenge in Modern Clinical Development

Clinical trials have become increasingly complex. Protocols are longer and more demanding, patient populations are narrower, and global regulations continue to evolve. Manual reviews and traditional monitoring methods are no longer enough to keep up with the pace and precision required in today’s research environment.

AI bridges that gap. It automates time-consuming reviews, identifies risks earlier, and provides predictive insights that human teams can act on before delays or deviations occur. Calance’s solutions bring together clinical expertise, data science, and agentic AI solutions to help your teams achieve operational excellence while maintaining full regulatory compliance.

The Challenge in Modern Clinical Development

Our Core Solutions

Calance’s clinical trial solutions focus on three key areas where automation and intelligence can deliver measurable impact:

Protocol Complexity Assessment

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A well-designed protocol is critical to a successful clinical trial. However, even small oversights can lead to costly amendments, extended timelines, and patient dropouts.

Our Protocol Complexity Assessment uses natural language processing and large language models to analyze clinical trial protocols and assess their operational feasibility.

Key features include:
  • Detection of complexity factors such as excessive inclusion criteria, visit frequency, or endpoint definitions
  • Generation of a Complexity Score benchmarked against similar studies and therapeutic areas
  • Identification of operational risks and areas that may increase patient or site burden
  • Recommendations for optimizing protocol structure before finalization
Benefit
By highlighting potential challenges early, this solution allows clinical planners to refine their protocols, reduce site workload, and increase the likelihood of timely trial completion.

Patient Enrollment Forecasting

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Patient enrollment is one of the most unpredictable elements in clinical research. Slow or uneven recruitment can delay even the most well-planned trials.

Our Patient Enrollment Forecasting solution applies predictive analytics and machine learning to monitor ongoing enrollment trends and forecast potential delays.

What it delivers:
  • Continuous tracking of actual vs. target enrollment across all sites
  • Predictive models that identify underperforming sites before delays occur
  • Scenario simulations to evaluate potential mitigation strategies
  • Interactive dashboards for operational teams to monitor performance in real time
Benefit
This proactive approach enables sponsors to intervene early, reallocate resources, and keep enrollment on schedule — reducing costs and maintaining study momentum.

Regulatory Compliance and SOP Gap Analysis

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Our AI-powered Regulatory Compliance and SOP Gap Analysis platform uses NLP and advanced comparison models to assess clinical SOPs against the latest FDA, EMA, and ICH-GCP guidelines.

It helps maintain compliance and quality assurance while keeping organizations prepared for evolving regulatory expectations.

Key features include:
  • Automated comparison of SOPs against updated guidance documents
  • Identification of ambiguous language, missing controls, or procedural gaps
  • Traceability to specific clauses within relevant regulations
  • Prioritized gap reports with recommended corrective actions
Benefit
By highlighting potential challenges early, this solution allows clinical planners to refine their protocols, reduce site workload, and increase the likelihood of timely trial completion.

How Our Solutions Work Together

Our tools address different stages of the trial lifecycle. Together they form an intelligence layer that supports smarter decision-making across your organization.

During planning

During planning

Protocol complexity assessment ensures trial feasibility.

During execution

During execution

Patient enrollment forecasting maintains operational control.

During compliance review

During compliance review

AI-driven SOP analysis keeps documentation aligned and audit-ready.

We transform isolated operational data into connected insights, improving both trial predictability and overall research efficiency.

Our Implementation Methodology

Delivering AI in a regulated environment requires rigor, validation, and collaboration. Calance follows a structured methodology designed to meet both scientific and compliance expectations. 

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1. Discovery and Data Assessment

We start by understanding your existing data landscape — from protocol templates and site metrics to SOP repositories and regulatory archives. This discovery phase defines project scope, data accessibility, and measurable success metrics.

Solution Design and Model Configuration

2. Solution Design and Model Configuration

Based on your trial portfolio and operational needs, our team configures solutions with relevant clinical, operational, and regulatory datasets. Custom taxonomies and ontologies are created to ensure high accuracy in terminology recognition and risk classification.

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3. Validation and Pilot Execution

Before full rollout, every solution  undergoes controlled pilot testing to validate performance, accuracy, and reproducibility. Each pilot is documented in line with Standardised SDLC Frameworks, and comply with 21 CFR Part 11 GxP, EU AI Act requirements to ensure audit readiness

In cases additional compliance measures are required, pilots can also incorporate ISO 27001 and NIST-aligned practices to further enhance data security and governance.

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4. Deployment and Integration

We deploy the solution in your preferred environment — whether standalone or integrated into existing systems like CTMS or eTMF. Our engineers work closely with IT and data teams to maintain performance and security standards.

Solution Design and Model Configuration

5. Training and Continuous Optimization

Post-deployment, we provide end-user training for clinical, regulatory, and operations teams. Our solutions continue to evolve as they process more data, improving accuracy and relevance over time. Regular optimization cycles ensure lasting value.

Security and Compliance by Design

All Calance AI solutions are developed under a strict governance framework. Security and compliance are not added later; they are integral to every design decision.

Security controls include:

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    Encrypted data transfer and storage

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    Multi-factor authentication and least-privilege access

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    Comprehensive logging of all user activity

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    Built-in audit trails and validation reports

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    Compliance with SDLC Frameworks, 21 CFR Part 11, GxP, EU AI Act21 and GDPR requirements

Our validation documentation ensures every analytical model, dataset, and workflow is fully traceable and defensible during audits or regulatory inspections.

Security and Compliance by Design
Why Life Sciences Organizations Choose Calance

Why Life Sciences Organizations Choose Calance

Calance combines deep domain knowledge with AI and data science expertise. Our teams understand both the scientific precision required in clinical research and the operational discipline needed for regulatory compliance.

Our differentiators:

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    Proven track record in implementing AI within regulated industries

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    Customizable frameworks that adapt to your specific therapeutic areas

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    Enterprise-grade scalability and support for global deployments

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    Transparent algorithms with human oversight at every stage

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    Commitment to measurable outcomes, not just technology delivery

We partner with sponsors, CROs, and research organizations to enable smarter, faster, and more compliant trials—without disrupting their existing infrastructure.

Bring intelligence into every stage of your clinical development process

Calance helps life sciences organizations move beyond manual analysis and reactive decision-making. With AI-driven insights, predictive monitoring, and continuous compliance tracking, your teams can manage trials with clarity and confidence.

Frequently Asked Questions

What kind of results have organizations achieved with Calance’s AI-Powered Clinical Trial Solutions?

Clients have reported faster protocol reviews, improved site performance visibility, and fewer compliance observations during audits. By combining automation with expert oversight, many organizations have shortened overall trial timelines while maintaining full regulatory confidence.

How easily can these solutions integrate with our existing clinical systems?

The platform is designed to integrate with most clinical trial management systems, electronic data capture platforms, and regulatory document repositories. Our APIs and data connectors ensure minimal disruption while providing seamless data exchange.

How does Calance maintain data privacy and compliance with global regulations?

We follow a secure development lifecycle that includes encryption, anonymization, and strict access controls. Our systems comply with 21 CFR Part 11 GxP, EU AI Act and GDPR standards. Client data is processed within secure, validated environments that meet global data protection requirements.On client request, we can include ISO 27001 and NIST compliant practices as well

Can these solutions be customized for specific therapeutic areas or study types?

Yes. Our AI solutions are configurable to recognize domain-specific terminology, study designs, and operational nuances. This allows the system to deliver accurate insights across diverse therapeutic areas including oncology, cardiology, neurology, and rare diseases.