When Seagen (pre-Pfizer acquisition) first engaged us, their critical event application for Medical Affairs was so unreliable it required an on-site employee to manually restart it from a closet. We were brought in for an emergency six-week fix, which evolved into a multi-year strategic partnership.
We transformed the single failing app into a robust, cloud-native ecosystem, starting by building a custom, compliance-first CMS. During the pandemic, we migrated it to a horizontally-scalable Azure cluster to support a new 24/7 public-facing website on an "impossible" two-month timeline. The platform's greatest win was solving the industry's core compliance bottleneck. By integrating the clinicaltrials.gov API, we automated the content engine. This innovation slashed the legal/compliance review for clinical trial data from months to minutes —a workflow Pfizer's integration team later cited as a best-in-class solution, as their own process took up to six months.
In 2018, the Medical Affairs team’s event application, built in Angular 1, was notoriously unreliable. It was plagued with bugs, memory leaks, and stack overflows, causing it to freeze frequently. This instability culminated at a major conference where an agency employee had to be "hidden in a closet" for the sole purpose of restarting the app.
This initial firefight revealed a deeper, systemic problem. The app was not fed by a database, but by a static JSON file that was manually built by a technical manager.
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Unstructured Data: This manager had to chase down unstructured data from dozens of sources, including Excel sheets, PowerPoint decks, Word docs, and even handwritten notes.
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Compliance Risk: This manual process was slow, dangerously error-prone, and had no version control or single source of truth.
Phase 1:
The 6-Week Rescue (Triage and Stabilize)
Given a hard six-week deadline, a complete rebuild was impossible. Our mission was stabilization, focusing 100% on the app's performance and ignoring the larger data integrity problem for the time being.
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Surgical Fixes: Our team triaged the legacy Angular 1 codebase and surgically addressed the most critical flaws, eliminating approximately 25 high-priority bugs.
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Performance Resolution: This involved resolving the complex memory leaks and stack overflows that caused the application to crash.
Result: Flawless Event & Foundation of Trust
Six weeks later, the application ran flawlessly for the entire next event with no crashes or freezes. For the first time, no dedicated technical support was needed on-premise, a stark contrast to the previous "guy in a closet" scenario. This success earned us the trust needed to propose a permanent solution.
Phase 2:
The Strategic Platform (Control and Compliance)
We spent the next six months architecting the permanent solution. The goal was to empower the Medical Affairs team to manage their own content and build a system that respected strict legal and regulatory review processes.
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Custom CMS: We built a full-scale, cloud-hosted Keystone CMS connected to a new client-facing "kiosk" application.
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True Content Ownership: The Med Affairs team gained the ability to directly manage all copy, images, and event-specific sections without any technical intervention.
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Compliance-Driven Version Control: This was the critical innovation for legal review. Our system allowed the team to create versions of content for specific events without altering the core, general-purpose content, streamlining the meticulous legal review.
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Scalability Spread: The success led the European team, who were using a deprecated Adobe Flex app, to adopt the platform, driving the development of multi-language support and a fully responsive architecture.
Result: Process Velocity (From Months to Weeks)
The new platform was a strategic game-changer. The streamlined workflow and version-control system slashed the average event content preparation time from 2–3 months down to just 2 weeks.
Phase 3:
The Pandemic Pivot (From Internal Tool to Public Website)
In March 2020, the COVID-19 pandemic necessitated an urgent pivot. With less than two months, the project scope exploded: we needed to build an entirely new, public-facing website to serve the kiosk’s content 24/7.
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Agile Development: We ran a highly iterative agile process, holding daily demos with the Med Affairs team to proactively benchmark competitors and deliver a permanent, scalable digital asset.
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Massive Infrastructure Upgrade: The existing small Linode/MongoDB server could not handle the anticipated public traffic. We led a high-stakes migration to a horizontally-scaled Azure cluster and CosmosDB.
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Guaranteed Uptime: We delivered the final product a week early, allowing automated stress tests simulating 20,000 to 50,000 concurrent users, guaranteeing 99.9% uptime.
Result: A Permanent Strategic Win
The infrastructure we built handled the virtual event load effortlessly. The project was such a success that the Medical Affairs team immediately decided to keep the new public website as a permanent 24/7 digital hub.
Phase 4:
The Game-Changer (From Weeks to Minutes)
The success of the public website led to the "CMS 2.0" mandate: natively manage both the kiosk and the website from a single, unified backend. This rebuild allowed us to solve the single biggest bottleneck in MedTech content.
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Compliance-Embedded Workflow: We re-architected the CMS (Node, Express, Vue 2) to embed the legal review process directly into the platform’s DNA. This included a multi-stage content lifecycle (Draft, Approved).
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Atomic Swapping: The "Request a Change" feature created a duplicate of live content for editing, which was then re-approved before atomically swapping with the live version, ensuring the public site was 100% compliant at all times.
Solution: The Clinical Trials API
The "killer feature" was integrating the clinicaltrials.gov public API. The manual process for publishing trial data took weeks of writing, reviewing, and correcting. We identified the API as the "single source of truth"—data that was already vetted, structured, and legally compliant by definition.
Result: The "Weeks to Minutes" Breakthrough
This API integration automated compliance, slashing clinical trial data publishing from weeks to minutes. The Med Affairs team could now pull fully approved content with a click. Pfizer's integration team later highlighted the immense value of this solution, noting their own 6-month process for approving just 3–5 trials.
Phase 5:
The Resilient, Hybrid-Ready Platform
The final phase modernized the "Kiosk 3.0" front-end (Vue 3) based on a formal UI/UX prototype. This architecture delivered two critical wins for resilience:
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Offline-First Caching: The app cached all content in the browser, ensuring the kiosk worked flawlessly during event Wi-Fi failures.
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Intelligent API Gating: Recognizing that the clinicaltrials.gov API was having interruptions , we architected our CMS to poll the API, check for changes, and store the data. If the external API failed, our system served its own last-known-good, approved data, guaranteeing 100% uptime.
Result: The Ultimate Goal Achieved
This created a true hybrid-ready platform with zero need for on-premise infrastructure. The Med Affairs team could focus on content, not technology. This system seamlessly served both the 24/7 public website and offline-ready event kiosks and ran flawlessly until the Pfizer acquisition.
Conclusion:
A Best - in - Class Digital Asset
Our partnership with Seagen evolved from a six-week rescue mission to a multi-year digital transformation. We listened and built a custom, resilient ecosystem that solved the core MedTech compliance bottleneck. The ultimate validation was the "months to minutes" automation of clinical trial data—a strategic win recognized by Pfizer as a best-in-class solution.
Ready to achieve compliance velocity and transform your content management workflow?
Frequently Asked Questions
Q: What is the biggest bottleneck in Medical Affairs content?
A: The biggest bottleneck is the legal and compliance review process. Manually creating, reviewing, and approving content (especially for clinical trials) can take 2-3 months, is prone to errors, and creates a significant delay in go-to-market.
Q: How can you automate pharma compliance for clinical trial data?
A: The most effective method is to integrate a "single source of truth," such as the clinicaltrials.gov API. By building a CMS that caches and serves this pre-vetted data, you can reduce the compliance review from months to minutes and ensure 100% accuracy.
Q: What is the ROI of a Medical Affairs CMS?
A: The ROI is measured in speed and risk reduction. Our platform for Seagen cut event prep time from 3 months to 2 weeks (a 6x improvement) and later automated clinical data publishing, saving hundreds of hours of manual legal review.
Q: How quickly can your automation solution approve clinical trial data for publishing?
A: Our custom solution, which integrates the clinicaltrials.gov public API, automates compliance checks and cuts the legal/regulatory review process for trial data from months to just minutes.
Q: What was the primary compliance bottleneck solved in this pharma case study?
A: The primary bottleneck was the manual, slow, and high-risk process of collecting and getting approval for clinical trial data from unstructured sources. We solved this by establishing the API as the single source of truth and embedding the legal review workflow into a custom CMS.
Q: What type of technology or platform was used to build this compliance-first CMS?
A: We built a custom, compliance-first Keystone CMS utilizing a modern stack (Node, Express, Vue) and migrated the infrastructure to a horizontally-scaled Azure cluster with CosmosDB to ensure 24/7 uptime and scalability.
Q: Who should use a solution designed for "Compliance Velocity"?
A: This solution is designed for Medical Affairs and Legal/Regulatory teams within pharmaceutical and biotech companies who need to accelerate their content publishing, significantly reduce compliance risk, and achieve compliance velocity without compromising accuracy.
Q: Can the custom platform manage content for both public websites and internal event applications?
A: Yes. The platform was architected to seamlessly manage and serve content to a 24/7 public-facing website and an offline-first event kiosk (Kiosk 3.0), guaranteeing data integrity and uptime regardless of event Wi-Fi reliability.
Q: How does the system ensure compliance is maintained on the live, public-facing website?
A: We implemented an "Atomic Swapping" feature. When an update is requested, a duplicate of the live content is created for editing and re-approval. Once approved, it is atomically swapped with the live version, ensuring the public site is 100% compliant at all times.