Clinical Trial Management System Development
to boost research efficiency, ensure compliance & accelerate breakthrough discoveries.
About
A US-based imaging core lab sought to enhance clinical trial management and engaged with Rishabh Software to develop a streamlined CTMS for multicenter studies. The Healthtech client was facing challenges in organizing, storing, and retrieving clinical data. They needed an advanced, scalable clinical trial management system and partnered with us to handle large volumes of medical imaging data efficiently. They leveraged our experience in healthcare software product engineering to implement a centralized CTMS.
Capability
Software Product Engineering
Industry
Healthcare
Country
USA
Key Features
To address the client’s complex requirements, we developed a comprehensive clinical trial management software that efficiently streamlined the vast amount of data, documentation, and processes involved in clinical trials. The key features of this CTMS include:
Collaborative Platform
The clinical research management platform acts as a centralized communication hub that enables swift and seamless collaboration among researchers, clinicians, and sponsors. It generates real-time insights into trial progress and performance, improving decision-making throughout the trial.
Enhanced Reporting and Analytics
The system’s advanced reporting and analytics tools let clients track trial progress, spot data trends, and create detailed reports. This helps research institutions and pharmaceutical companies make better decisions based on real-time insights, improving overall trial outcomes.
Multi-Level Trial Management
The clinical trial management software supports comprehensive trial management. It facilitates the easy onboarding of new companies with multiple trial setups and manages detailed subject information. The system also tracks visits and securely stores complete visit data, including reports, images, PDFs, and DICOM files for advanced medical imaging.
Customizable Data Forms and Templates
Our CTMS development approach integrated customizable forms and templates for various trial data types. This flexibility ensures that data collection aligns with the specific requirements of clinical study management while also maintaining thorough documentation and efficient data management.
Challenges
- Inefficient data management of diverse data posed a serious risk to trial integrity and accuracy
- Ensuring regulatory compliance throughout the trial process was complex and time-consuming
- System integration failures often created data silos and disrupted operations
- Scalability issues caused delays and performance bottlenecks as trials increased
- Lack of real-time data access hindered timely decisions and resource allocation
- Interoperability gaps led to challenges in data exchange, increased manual efforts, & risked data transfer errors
Solution
Our team of experienced software product engineers addressed key challenges like eliminating data silos, improving security, and ensuring smooth interoperability. We developed a comprehensive CTMS that accelerates trials, reduces costs, and maintains the highest data integrity and patient safety standards. The new system meets all regulations and integrates effortlessly with various pharmaceutical and healthcare systems.
Interoperability and Integration Capabilities
We created standardized data exchange formats and robust APIs to facilitate smooth integration with external systems like EHRs, imaging tools, and LIMS. By Integrating these diverse systems, the system adheres to industry standards for data interoperability, facilitates seamless data exchange, and enhances overall efficiency.
Trial Management System & Configuration Application
The CTMS offering comprises two key components – a comprehensive trial management system and a setup & configuration Windows application for system customization. This dual approach ensures user-friendly operation for research teams and flexible administration for IT staff, efficiently addressing diverse clinical research needs.
Centralized Data Management
Utilizing our data architecture and management expertise, we created a secure, centralized database for efficient data storage and retrieval. It supports customizable forms and templates for various clinical trial data and ensures accuracy and consistency.
Automated Regulatory Compliance
The clinical trial management system has built-in checks and validation rules to meet regulatory requirements such as FDA and EMA. It automates the creation of documents and reports. This reduces the risk of non-compliance and ensures that documentation meets industry standards and regulatory guidelines.
Technologies Used
Project Snapshots
52%
reduction in time spent on data management with automation
2X
boost in regulatory compliance efficiency with built-in checks
50%
faster trial onboarding with streamlined processes
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