We created a laboratory information management system for one of the largest clinical networks in the world. Architecture, implementation, workflow management services
Regulatory information used to move between life sciences companies and regulators via one-off document exchange. That is until a regulatory-technology organization set out to replace that model with a secure shared cloud platform.
The organization worked with Coherent Solutions to build and scale the platform. Our teams worked on the backend, frontend, DevOps, manual and automated QA, architecture, delivery, monitoring and design system work and took the product from early development to its first production release.
The outcome was a platform that enabled shared regulatory dossiers, real-time information exchange, workflow automation and reliance and work sharing pathways.
At a glance
Client: Regulatory-technology organization serving life sciences companies and health authorities.
Industry: Life sciences, biotechnology, regulatory technology.
Challenge: Rapidly expand engineering capacity, put in place stronger delivery practices and deliver a secure regulatory collaboration platform on very tight timescales.
Solution: A cloud-native SaaS platform with shared dossier review, centralized content, real-time exchange, workflow automation, monitoring and scalable architecture.
Outcome: Production launch, real-world use by a number of major life sciences organizations and a platform that is easier to scale and maintain.
Coherent's role: Major engineering partner, providing over 50% of the engineering capacity across Java development, frontend, DevOps, manual and automated QA, project management, monitoring, UX/UI design systems, architecture and support.
Client overview
The client is a regulatory technology company focused on improving how life sciences companies and regulators share information.
Its cloud platform replaces the old one-to-one document exchange with a shared environment. The appropriate stakeholders can then view the content, raise queries, respond, manage milestones and collaborate across organizations and jurisdictions.
The challenge
The client needed to add engineering capacity quickly in a regulated and security-aware environment and didn't have an in-house recruiting function.
A previous vendor engagement hadn't delivered on what the client was looking for. They needed a partner that could bring accountable teams, establish better delivery practices and be involved across the entire product lifecycle.
Our approach
Coherent Solutions began by upskilling their frontend and backend engineers and establishing an accountable, problem-solving delivery model.
As the engagement grew, we added in DevOps, manual QA, automated QA and project management. The functional teams were restructured into Scrum teams so that the workstreams could run in parallel which made progress more visible.
Technical investigation, monitoring, architectural re-design and process improvements were all undertaken to deal with the issues of performance, cost, scalability, stability and maintainability as the platform progressed towards production.
The solution
The platform gives authorized life sciences organizations and regulators one secure place to work. It supports:
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Secure, authorized collaboration between life sciences organizations and regulators
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Shared dossiers accessible to multiple regulatory participants
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Centralized document upload, organization, search, and review
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Real-time questions, answers, and updates
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Milestone tracking, notifications, task assignment, and workflow automation
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Platform monitoring
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Integration with related third-party platforms
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Architecture changes to improve scalability and maintainability
The impact
The engagement took the platform from early development to production and into real-world use. Milestones and outcomes included:
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Migration of infrastructure from Google Cloud Platform to Microsoft Azure
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Real-world use of the platform by major life sciences organizations
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Improved monitoring, performance, stability, scalability, and infrastructure efficiency
What's next
The platform keeps growing, with a new configurable project model and more third-party integrations already in progress.
This case is an example of how Coherent Solutions helps teams bring complex, regulated products to production, with engineers who share ownership of the result.
