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Custom Clinical Data Management (CDM) Software Development

At smartData, our experts design and develop Custom Clinical Data Management (CDM) Software that empowers healthcare organizations to efficiently collect, validate, and manage clinical trial data with precision and compliance. Our tailored CDM solutions ensure data accuracy, integrity, and security throughout every stage of the clinical research lifecycle—helping you accelerate drug development and streamline regulatory submissions.

Our expert team works closely with clinical research professionals to build software that fits your exact workflow and study requirements. From automated data capture, query management, and validation checks to audit trails, discrepancy tracking, and real-time analytics, we provide everything needed to simplify complex data operations while maintaining full compliance with GCP, FDA, and CDISC standards.

Using advanced technologies such as AI, cloud computing, and automation, our CDM systems enhance data transparency, scalability, and collaboration across research teams and CROs. The solution easily integrates with EDC, CTMS, and other clinical systems, ensuring smooth data flow and centralized access to critical insights.

Partner with smartData to develop an intelligent and compliant Clinical Data Management software solution that minimizes errors, boosts efficiency, and accelerates research outcomes—so your teams can focus on what truly matters: improving patient health and advancing medical innovation.

smartData core Custom Clinical Data Management (CDM) Software Development services

01

Requirement & Workflow Consulting

Our expert team begins by working closely with your clinical, research and IT stakeholders to map your protocols, data-flows and existing systems. We identify pain-points, regulatory needs (GCP, CDISC, 21 CFR Part 11) and desired outcomes, then craft a tailored CDM software plan that aligns with your trial or study workflow.

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02

CRF / eCRF & Database Design

We design the case report forms (CRFs) or electronic CRFs (eCRFs) and build the underlying database structure to capture your study data accurately. Our experts apply best-practice standards, ensure audit readiness, and drive efficient data collection, all customised to your study’s protocol and user-roles.

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03

Reporting, Dashboards & Analytics

Our expert team builds intuitive dashboards and reporting modules so your study teams can monitor progress, site performance, data trends and key metrics in real time. You gain up-to-date visibility into your data landscape and can make informed decisions faster.

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Recent Portfolio Projects

01 3
AI Fashion Management System

AI Fashion Management System

The system aims to revolutionize how users discover, visualize, and shop fashion online by merging artificial intelligence,  garment visualization with different dimensions, and e-commerce into one immersive ecosystem. Core Offerings 

  1. Personalized avatars with different dimensions
  2. Virtually try on garments in real-time
  3. Receive AI-powered styling recommendations
  4. E-Commerce Cart

The ultimate goal is to deliver a personalized, data-driven, and sustainable digital fashion experience, empowering both users and designers. By leveraging AI styling intelligence, visualization, and real-time engagement analytics, this system bridges the gap between fashion creativity and cutting-edge technology positioning itself as the future of virtual fashion retail.

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BQP RM FG Demand Forecasting and Planning

BQP RM FG Demand Forecasting and Planning

To design and implement an integrated, automated planning and forecasting platform that enhances forecast accuracy, eliminates manual and siloed processes, provides real-time visibility into key business metrics, and enables seamless collaboration across planning, sales, and supply chain teams—empowering the organization to respond pro-actively to market changes and make informed, data-driven decisions across short- and long-term planning cycles.

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Chat RX

Chat RX

Facilitaties patients to chat with AI based Medical Assistant to share the current medical condition symptoms

Medical Assistant assess the diagnosis and generate the prescription for the assessed diagnosis.

Facilitates patient to generate the work notes

Patient can find the pharmacy with cheepest medicine prices, local pharmacies etc.

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What our clients say about smartData

Ben

Ben

We have clients throughout Australia, New Zealand and Asia. smartData...

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Jatin

Jatin

Team smartData guided us through every stage, from business analysis...

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Gavin

Gavin

We recently partnered with smartData,for a critical workforce management project....

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Christopher

Christopher

It’s been a great experience working with smartData. I am...

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Justin

Justin

I have worked with many developers and agencies in past....

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smartData Benefits

Global Talent Pool

We boast nearly 1,000 highly skilled developers strategically positioned across three offshore locations, enabling us to deliver world-class software solutions. 

Proven Track Record

With a proven track record of delivering over 10,000 diverse software applications worldwide, we have honed our expertise to perfection.

Worldwide Presence

smartData Enterprises boasts a robust global footprint, with a strong foothold in key regions such as the US, Australia, Europe, and Japan.

CMMI/ISO certifications and accreditation

smartData’s CMMI Level 3 and ISO 9001:2015 certifications showcase our commitment to quality and consistency, with a focus on client success. As we aim for CMMI Level 4, we’re driving greater efficiency and innovation.

Frequently Asked Questions

Yes. We build our CDM software around seamless integration. Our experts ensure smooth data exchange and interoperability with your existing EDC (Electronic Data Capture), CTMS (Clinical Trial Management System), EHR/EMR or other platforms. This avoids silos, duplicates and manual workflows, helping your teams work smarter.

At smartData, compliance is built in. Our CDM solutions are developed in accordance with standards such as GCP, FDA, HIPAA, GDPR depending on your geography and your trial type. We implement secure architecture (encryption, audit‐trail, role‐based access) and ensure the software supports your regulatory documentation and submission needs.

The timeline depends on the scope: number of protocols, forms, sites, complexity of workflows and integrations. Our expert team first works with you to define requirements, then uses agile development to deliver incremental modules. Typically we aim for a minimum viable system within a few weeks, and full rollout thereafter – always aligned with your study milestones.

Very flexible. Our expert development process uses modular architecture and configurable workflows. If your protocol changes, new forms are added, or additional sites come online, we adapt the system quickly. We provide ongoing support and updates, so your CDM software evolves with your study rather than becoming a bottleneck.

We provide full support. After deploying your CDM system, our expert team remains available for monitoring, bug-fixes, updates, and enhancements. We ensure your software stays secure, up-to-date, and aligned with evolving regulatory or operational requirements. We aim for long-term partnership, not just one‐off delivery.

Yes, our expert team handles smooth and secure data migration from legacy CDM or EDC systems to the new platform. We ensure no data loss, maintain consistency, and validate accuracy at every step to guarantee a safe transition.

Our experts use modern technologies including cloud computing, AI/ML, APIs, and data analytics frameworks. Depending on your requirements, we build scalable solutions using secure platforms like AWS, Azure, or private cloud environments.

Yes, both. Our experts offer flexible deployment—cloud-based for easy scalability and access, or on-premise for organizations needing complete data control. We help you choose the model that best fits your compliance and IT infrastructure.

Simply reach out to our expert team at smartData. We’ll discuss your study goals, workflows, and technical needs, then craft a custom Clinical Data Management solution that helps you achieve accurate, compliant, and efficient trial outcomes.