Free Trial

A U.S. nationwide medical-care provider

Delivering an FDA-compliant electronic clinical trial system

21 CFR Part 11

compliance requirement

Weekly

prioritisation and delivery

Continuous

planning and feedback

Talk to an expert

A U.S. medical-care provider wanted healthcare practitioners to receive timely information and make better patient decisions. The system had to improve communication and collaboration while complying with the FDA’s 21 CFR Part 11 requirements.

Challenge

01

Clinical users needed timely information and dependable collaboration across changing healthcare workflows.

02

The solution required auditability, authentication and controlled access consistent with FDA electronic-record requirements.

03

Business priorities changed week by week, making a fixed long-range delivery plan impractical.

Solution

Delivered an electronic clinical trial system on SharePoint with audit trails, authenticated InfoPath report access and actions, and controlled clinical collaboration sites.

Tech:

SharePointInfoPathAgile21 CFR Part 11

How we worked

01

Used Agile discovery to identify the core clinical process and the highest-value requirements quickly.

02

Created a simple architecture, divided the product into focused modules and delivered each as a short business-to-solution cycle.

03

Prioritised, planned and implemented new value weekly, with continuous client feedback and refactoring.

04

Adapted each release as requirements evolved while keeping progress visible through frequent working software.

Result

Delivered a working SharePoint electronic clinical trial system with audit and authentication capabilities.

Enabled early and continuous visibility into development progress through valuable software releases.

Responded faster to changing clinical and customer requirements.

Industry

Healthcare

Services

Custom Development System Integration

Technologies

SharePointInfoPathAgile21 CFR Part 11

Business Impact

ComplianceClinical CollaborationAdaptability

Related Cases

A global freight-forwarding and logistics provider

Unified

platform integrating all logistics operations

Real-time

visibility of shipment tracking and inventory management

Freight forwarding and warehouse management system for global logistics provider

Shinetech built a comprehensive online logistics and warehouse-management system to digitize and unify the client’s freight-forwarding and warehouse operations

READ MORE

Ready to build your next success story?

We listen first, then work with you to craft solutions that are thoughtful, reliable, and built to last.

Talk to an Expert