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Solutions and Services

Advanced Solutions

Proven Strategies

Scalable Results

Electronic Data Capture (EDC)

Streamline clinical trial data capture and management with IDS EDC, a robust platform designed to handle complex studies while ensuring compliance and accuracy.

AI-Powered Data Transformation: Automatically map raw data to CDISC SDTM standards, reducing manual coding efforts by 70%.
Real-Time Validation: Flag discrepancies (e.g., out-of-range values, protocol deviations) during data entry with customizable edit checks.
Cross-Platform Interoperability: Integrate with EHRs, labs, and wearables via HL7 FHIR for seamless data flow.
Advanced Analytics: Built-in tools for real-time data visualization, trend analysis, and predictive risk monitoring.
Offline-to-Online Sync: Pair with Direct Data Capture (DDC) for uninterrupted data collection in low-connectivity regions.

"From site to submission, IDS EDC ensures your data is audit-ready, compliant, and actionable."

eConsent

Enhance patient understanding and trial efficiency with IDS’s digital consent solutions, designed for hybrid, site-based, or fully decentralized trials.

Virtual Consent Workflows: Conduct remote consent sessions with video verification and multilingual e-signature support.
AI Comprehension Checks: Analyze patient interactions (e.g., time spent on sections) to identify misunderstandings and improve informed consent.
Dynamic Updates: Push protocol amendments to patients in real-time, with tracked acceptance for audit trails.
Integration with DCT & ePRO: Combine with Decentralized Trials and ePRO to create a unified patient journey.
Compliance Assurance: Meet 21 CFR Part 11, GDPR, and ICH GCP requirements with encrypted storage and role-based access.

"Turn consent from a checkbox into a conversation—while keeping compliance at the core."

Decentralized Clinical Trials (DCT)

Reduce patient burden, accelerate enrolment, and cut costs—without compromising data quality

Our EDC platform enables decentralized trials with eConsent, ePRO, RTSM, and DDC. Whether you opt for a hybrid study or a fully virtual approach, our flexible technology enhances data quality, reduces patient burden, and supports a bring-your-own-device model.

Hybrid & Virtual Models: Support remote visits, telehealth integrations, and BYOD (Bring Your Own Device) strategies.
Real-Time Monitoring: Track patient adherence, safety signals, and PRO data via integrated dashboards.
Unified Ecosystem: Combine EDC, eConsent, ePRO, and RTSM for a fully decentralized workflow.
Regulatory Readiness: Pre-configured templates for FDA, EMA, and MHRA submissions.

Direct Data Capture (DDC)

Capture Data at the Source—Anywhere, anytime

IDS DDC ensures seamless site and patient data entry, even offline or in low-bandwidth areas. With auto-sync to EDC, it eliminates data silos, reduces delays, and enhances efficiency in clinical trials.

Offline Functionality: Collect data in remote areas; auto-sync to EDC once connectivity resumes.
AI-Powered Error Prevention: Validate entries in real-time (e.g., duplicate checks, protocol alignment) even offline.
eSource Simplicity: Replace paper forms with customizable eCRFs, reducing transcription errors by 90%.
FHIR-Enabled: Integrate with wearables and IoT devices for continuous vital sign monitoring.
Cost-Effective: Eliminate paper, printing, and manual data entry costs.

Electronic Patient Reported Outcomes (ePRO)

Capture real-world insights directly from patients with IDS ePRO, designed to boost engagement and data accuracy.

Patient-Centric Design: Gamified surveys, SMS reminders, and intuitive mobile/tablet interfaces.
AI-Driven Adherence Alerts: Predict and address missed entries using behavioral analytics.
Real-Time Analytics: Monitor symptom trends, side effects, and QoL (Quality of Life) metrics on dashboards.
Multi-Modal Inputs: Support voice, text, and wearable integrations for diverse patient needs.
Regulatory Compliance: Align with PRO Consortium guidelines and eCOA best practices.

Protocol-to-Submission Automation

AI-Driven End-to-End Clinical Data Flow

Leverage AI to seamlessly interpret complex clinical trial protocols, automatically map data to standardized formats, and generate submission-ready outputs with minimal manual effort. Our intelligent automation ensures regulatory compliance, reduces time-to-submission, and enhances data accuracy, making the process more efficient and error-free.

AI-Powered Protocol Parsing: Automatically extract inclusion/exclusion criteria, study schedules, and endpoints from protocols.
SDTM & ADaM Automation: Generate compliant CDISC SDTM datasets and partially pre-populate ADaM datasets and TLFs (Tables, Listings, Figures).
Statistical Analysis Plan (SAP) Assist: AI drafts SAP sections, reducing manual effort by 50%.
Submission-Ready Outputs: Auto-compile final reports, TLFs, and audit trails for regulatory submissions.

Automated Data Quality Assurance

Real-Time Validation & Error Resolution

Maintain high-quality, reliable data across the trial lifecycle with AI-driven validation and anomaly detection. Our automated system continuously monitors, flags inconsistencies, and ensures adherence to data integrity standards, reducing the need for extensive manual data cleaning while improving compliance and overall study efficiency.

Real-Time Validation Rules: Flag inconsistencies during data entry (e.g., range checks, protocol deviations).
Automated Data Cleaning: Resolve duplicates, outliers, and missing values using AI-driven algorithms.
Data Lineage Tracking: Maintain full traceability from source to submission for compliance with FDA 21 CFR Part 11 and EMA guidelines.

Automated Study Scheduling

AI-Optimized Timelines & Resource Allocation

Eliminate the challenges of rigid and manual study scheduling with adaptive AI-driven tools. Our system dynamically adjusts timelines based on real-time data, patient availability, and study progress, optimizing resource utilization while ensuring flexibility and efficiency in trial execution.

Parameter-Driven Timelines: Auto-generate study schedules based on protocol requirements and historical data.
Real-Time Adjustments: Update milestones dynamically without disrupting workflows (e.g., patient enrollment delays).
Resource Efficiency: Predict and allocate staff, sites, and budgets to avoid bottlenecks.

CDISC & HL7 FHIR Integration

Seamless Compliance with Global Standards

Accelerate data standardization and interoperability with built-in CDISC and HL7 FHIR integration. Our solution ensures seamless data exchange between electronic health records (EHRs), clinical trial management systems (CTMS), and regulatory submissions, enabling faster decision-making and compliance with global data-sharing standards.

SDTM/ADaM Mapping: Auto-transform raw data into CDISC-compliant formats using predefined templates.
HL7 FHIR Interoperability: Integrate with EHRs, wearables, and labs for real-time data exchange.
Audit-Ready Metadata: Generate metadata and define.xml files automatically for regulatory inspections.

Statistical Analysis & Reporting Suite

AI-Augmented Analytics for Faster Insights

Enhance statistical analysis and reporting with preconfigured, validated tools designed to accelerate workflows. Our suite includes automated statistical models, real-time data visualization, and regulatory-ready reporting templates, reducing the burden on biostatisticians and improving the accuracy and speed of data insights.

Prebuilt Analysis Templates: Regression, survival analysis, ANOVA, and subgroup analyses.
R/SAS Integration: Seamlessly execute advanced statistical models within the IDS platform.
Auto-Generated TLFs: Produce submission-ready tables, listings, and figures with one click.

Study Closeout & Archiving

Automated Finalization and Compliance

Streamline study closure and long-term data management with automated workflows for final data reconciliation, report generation, and secure archival. Our system ensures compliance with regulatory requirements, facilitates seamless knowledge transfer, and enables easy retrieval of historical trial data for audits, future studies, or meta-analysis.

Report Compilation: Auto-generate final clinical study reports (CSRs) with integrated TLFs.
Secure Archiving: Store data in a 21 CFR Part 11-compliant repository with role-based access.
Audit Readiness: Pre-packaged audit trails and documentation for rapid inspector access.

DATAMATICA's IDS: A comprehensive CTMS for efficient trials.

IDS is a comprehensive Clinical Trial Management Solution, that helps to streamline clinical trials. Manage eConsent, ePRO, EDC, DCT and DDC for flawless data gathering, all from a simple interface. IDS can improve the patient experience while also accelerating research.