Cloud-Based Clinical Research Software

Investigational pharmacies that rely on Excel to compile protocol budgets must manually configure fees every time a new study is initiated — factoring in study phase, drug preparation, storage, and administration costs from scratch. This process is time-consuming, error-prone, and impossible to standardize across sites or studies. There is also no live linkage between the budget and the active protocol, meaning teams have no visibility into how approved costs compare against actual expenses as the trial progresses. Closeloop Technologies solved this by building a reusable, template-driven budget module directly inside the clinical platform — eliminating manual recreation and enabling real-time cost monitoring against active protocols.

Closeloop handled the complete end-to-end delivery — including requirements analysis, solution architecture, frontend UI design, backend development, third-party integrations, QA testing, user training, deployment, and ongoing maintenance. The platform was built on ASP.Net, VB.Net, SQL, JavaScript, and Backbone.js, with a full API suite enabling connectivity to external partners. The entire platform — covering frontend UI, solution architecture, coding, QA, training, and final deployment — was conceptualized and delivered within 4–5 months, demonstrating the team's ability to move fast without compromising on quality or clinical workflow accuracy.

A Protocol Checklist is a structured, template-driven task management system that tracks the status of every protocol development activity — from pre-approval tasks like Site Qualification and budgeting, to live-phase activities like drug builds in EMR systems and Vestigo build verification. Without it, sites resort to disconnected Excel or Word documents that are impossible to standardize across facilities. A properly implemented checklist assigns tasks to specific users, sets due dates, sends automated alerts for overdue items, and gives program managers a real-time view of protocol readiness. Closeloop Technologies built this capability natively into the Vestigo platform, replacing fragmented manual tracking with a single standardized system across all sites.

Investigational Drug Services operate at the intersection of multiple systems — EMR platforms for patient data, CTMS for trial management, and OnCore for research coordination. When these systems operate in silos, pharmacy teams must re-enter data across platforms, increasing the risk of errors, delays, and compliance gaps. Tight integration ensures that drug builds, patient enrollment status, IRB expiration dates, and trial updates flow automatically between systems — giving all stakeholders a consistent, real-time view without manual data reconciliation. Closeloop Technologies architected Vestigo's integration layer to connect seamlessly with OnCore, EMR systems, and CTMS, enabling a unified clinical workflow across all connected platforms.

Excel-based budget management in clinical research introduces significant operational and compliance risks — files go out of sync, version control is unreliable, there is no audit trail for changes, and there is no linkage between the budget document and the live protocol it governs. When a study becomes active, teams have no automated mechanism to monitor actual costs against approved fees, leaving financial oversight entirely dependent on manual reconciliation. For regulated environments like investigational pharmacies, this level of opacity is both operationally inefficient and potentially non-compliant. Closeloop Technologies replaced this fragile approach with an electronic budget module that is fully integrated into the clinical platform and linked directly to active protocols.

Protocol development involves dozens of sequential and parallel tasks — each with deadlines, responsible parties, and downstream dependencies. Without automated alerts, overdue tasks go unnoticed until they create a bottleneck or compliance gap. Automated alerts notify assigned users when tasks are approaching or past their due date, keeping the entire team accountable without requiring manual follow-up from program managers. Closeloop Technologies built this alerting and assignment logic into the Vestigo Protocol Checklist feature, ensuring that no task falls through the cracks regardless of how many protocols or sites are being managed simultaneously.

A fully custom clinical platform covering core workflow modules, third-party integrations, QA, training, and deployment typically takes 4–6 months for a focused initial scope, and 12–15 months for a comprehensive multi-module system with a full API suite and integrations to multiple external clinical systems. Closeloop Technologies delivered the initial Vestigo platform within 4–5 months and subsequently built and maintained the full production system — including all integrations with OnCore, EMR, and CTMS — within a 14–15 month total engagement, demonstrating both speed and depth in clinical software delivery.

A robust investigational drug service platform requires a reliable server-side framework for business logic, a structured relational database for audit-compliant data storage, a responsive frontend for clinical workflows, and a well-documented API layer for external integrations. Closeloop Technologies built Vestigo on ASP.Net and VB.Net for the backend, SQL for the database, JavaScript and Backbone.js for the frontend, with a comprehensive API suite supporting integration with OnCore, EMR systems, and clinical trial management platforms — a stack chosen for long-term maintainability and clinical-grade reliability.