Vantara : Software Design & Development
Summary
Vantara Medical Research is a clinical research firm conducting Phase II and Phase III pharmaceutical trials through a network of hospital partners and specialist clinics across the United States and Canada, independent of all study sponsors.
About Vantara Medical Research
Vantara Medical Research is a clinical research firm conducting Phase II and Phase III pharmaceutical trials through a network of hospital partners and specialist clinics across the United States and Canada, independent of all study sponsors.
Vantara's teams were juggling hundreds of moving parts patient enrolment tracking, protocol compliance, adverse event reporting, regulatory documentation, and sponsor communication all managed through a mix of spreadsheets, email threads, and a legacy trial management tool from the early 2000s that was no longer capable of managing modern multi-site trials.
Markeltree was hired to design and develop a custom-built clinical trial management system from scratch.
- Product Discovery and Regulatory Requirements Analysis
- Clinical Workflow UX Research and Design
- Full-Stack Software Development
- Multi-Site Role and Permission Architecture
- Regulatory Compliance Engineering
- Automated Reporting and Sponsor Portal Development
The Challenges
Every project starts with real problems. Here are the core challenges we tackled for this engagement.
The legacy trial management system lacked multi-site coordination functionality, requiring each clinic to maintain local records and manually reconcile them with the central Vantara team by email.
Enrolment and eligibility were tracked in spreadsheets, which were difficult to audit and subject to version inconsistencies between sites.
The paper-based adverse event reporting process required manual completion, document scanning, email submission, and re-entry into regulatory paperwork.
Sponsor organisations needed frequent progress reports that required several days of coordinator time to collate from various sources.
The platform had to comply with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures.
Core approach & deliverables
A breakdown of the core components built and delivered for this project.
Discovery and Regulatory Framework Design
Markeltree began with an extended discovery phase involving Vantara's clinical operations team, regulatory affairs team, and site coordinators from partner clinics. The software architecture was designed with FDA 21 CFR Part 11 compliance embedded from the ground up rather than applied as an afterthought, ensuring that every data flow, access control, and audit mechanism met regulatory requirements by design.
Centralised Multi-Site Coordination
The platform was built around a central data model that enabled all participating sites to contribute to a single source of truth rather than maintaining separate local records. Site coordinators accessed the system through role-based portals tailored to their specific trial responsibilities. Any changes at any site were immediately visible to the Vantara central team and authorised sponsor representatives.
Patient Enrolment and Protocol Compliance Engine
The platform guided site coordinators through a structured enrolment process covering screening criteria, consent forms, and protocol assignment. Automated compliance checks identified deviations from trial procedures before they became reportable violations, allowing sites to correct processes in real time rather than only discovering issues at audit.
Adverse Event and Safety Reporting Automation
The adverse event reporting process was redesigned as a fully digital workflow. Guided forms captured each event and automatically populated regulatory report templates. Completed reports were routed through a configurable approval pathway and delivered to sponsor safety teams, with a complete electronic audit trail meeting 21 CFR Part 11 requirements.
Sponsor Reporting and Transparency Portal
Sponsoring organisations were granted access to a transparency portal providing live visibility into enrolment progress, site performance, and protocol adherence. The manual process of spending days compiling weekly summary reports was replaced by automatically generated reports updated continuously from live trial data.
Key Outcomes & Impact
Custom clinical trial management platform replacing legacy tools and manual processes across all sites.
Centralised multi-site coordination eliminating local record silos and manual reconciliation.
Electronic records and electronic signature architecture compliant with FDA 21 CFR Part 11.
Fully automated adverse event reporting with electronic audit trail and configurable approval routing.
Live sponsor transparency portal providing real-time metrics on enrolment progress and protocol adherence.
Markeltree was aware of the regulatory landscape from the beginning and designed a platform that complies with these requirements without forcing coordinators to fill out compliance form after compliance form. It actually made their job easier.
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