SDC Sidekick™ AI for Clinical Trial Oversight | Explainable, Audit-Ready AI Built for Clinical Research

AI Built for Clinical Trials. Designed for Trust.

SDC Sidekick™ AI - Overview

Today, clinical trials generate more data than ever before—from EDC, CTMS, labs, wearables, ePROs, and other decentralized sources. Yet many teams still rely on disconnected systems, manual reviews, and delayed reporting to manage trial oversight.

SDC Sidekick™ changes that.

Embedded within SDC Insights™ 2.0, SDC Sidekick™ is an intelligent AI assistant purpose-built for clinical research. It helps clinical operations, data management, safety teams, and sponsors uncover trends, identify risks, and act faster—all while maintaining full regulatory transparency.

Unlike generic AI tools, SDC Sidekick™ operates within SDC’s validated environment, ensuring study data never leaves the platform and every AI-generated insight remains traceable to its source.

Empowering better clinical decisions through explainable, compliant, and actionable AI.

Natural Language Clinical Intelligence

Ask questions in plain language and receive contextual insights from your study data without requiring technical expertise or complex reporting tools.

Data-Grounded AI Responses

All insights are generated from your study data warehouse, reducing the risk of unsupported conclusions and ensuring responses remain relevant to your trial.

Transparency-First Design

Every AI-generated result can be traced back to the original source data, providing complete visibility into how recommendations and insights were produced.

Compliance by Design

Built-in audit trails, role-based access controls, explainability, and validation capabilities help organizations meet regulatory and quality requirements.

Closed-Loop AI Environment

Study data remains securely contained within SDC's validated ecosystem, with governance, version control, and traceability applied to every interaction.

Foundation for Continuous Innovation

Sidekick™ serves as the AI layer across the SDC platform, enabling future advancements in predictive analytics, automation, and intelligent clinical operations.

AI-Powered Risk Detection

Identify and prioritize emerging study risks in real time using predictive models tailored to your clinical program.

Role-Based Dashboards

Provide CRAs, CTMs, Safety Monitors, Clinical Operations leaders, and Biometrics teams with actionable, real-time insights specific to their responsibilities.

Unified Study Data

Automatically harmonize data from EDC, CTMS, IRT, laboratories, wearables, and other sources into a single centralized monitoring environment.

Explainable AI Outputs

Generate transparent recommendations with row-level traceability and validation to support regulated clinical environments.

FDA-Ready Oversight

Support inspection readiness with AI capabilities aligned to regulatory expectations and supported by SOC 2 and ISO-certified infrastructure.

Rapid Deployment

Go live in 30 days or less, often before First Patient In, without replacing existing EDC or CDMS systems.

Benefits of SDC Sidekick™ AI

Detect Risks Earlier-
Identify protocol deviations, safety trends, and performance issues up to 14 days sooner, allowing teams to take proactive action.

Improve Monitoring Efficiency
Reduce unnecessary site visits and focus resources on the sites, patients, and risks that matter most.

Speed Query Management-
Automatically draft routine queries (up to 60% auto-generated queries) and reduce administrative burden, freeing teams to focus on higher-value activities.
Give every stakeholder a unified view of study performance through centralized, real-time oversight.

Strengthen Regulatory Readiness-
Provide complete traceability, explainability, and documentation for AI-assisted decisions and actions. 100% pass rate in mock audits.

Scale Without Additional Headcount
Support growing trial complexity and data volumes without proportionally increasing operational resources.

SDC Clinical Stakeholders Visual (1)

FDA-Ready. Audit-Tested. ICH E6(R3) Compliant.

AI oversight tools that rely on black-box algorithms or disconnected data exports create unnecessary compliance risk. SDC Sidekick™ was purpose-built to deliver the transparency, traceability, and validation required in modern clinical development, helping teams operate with confidence under increasing regulatory scrutiny.

Designed to support the highest standards of quality and compliance:

SOC 2 Type II
ISO 27001
21 CFR Part 11
Instant revalidation of AI outputs
Zero FDA 483 observations across live pilot studies
Prepared for ICH E6 (R3) compliance frameworks

When regulators ask how a decision was made, your technology should provide a clear answer. With SDC Sidekick™, every insight is traceable, explainable, and audit-ready. If your audit trail doesn't show what your AI saw, reviewed, and analyzed, you're not audit-ready. With Sidekick™, you are.

Meet SDC Sidekick™ AI

Download the Sidekick™ Fact Sheet

Beyond Dashboards - The Future of AI-Native Trial Oversight

Read the blog post

Practical Guide to Implementing AI in Clinical Trials

Open the eBook

“We cut query triage time in half and finally have one dashboard that gives our team the full story—from safety signals to site performance.”

Director of Clinical Operations

Mid-Tier Pharma

“Sidekick made us stand out in a recent RFP. The explainability and speed to deploy are unmatched.”

Vice President of Data Science

Specialty CRO

“SDC Insights™ identified restrictive inclusion and exclusion criteria that slowed enrollment and allowed us to quickly mitigate enrollment challenges and expedite our study timelines.”

Chief Medical Officer