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Pharmaceutical
DevOps Services
Azure, Salesforce, ServiceNow, JavaEE, Oracle
The client is among the top 20 global providers of tech solutions for clinical trial processes in the pharmaceutical industry. Their Regulatory Information Management (RIM) platform streamlines the complex process of submitting drugs to regulatory agencies worldwide, automating submission planning, publishing, and management. The product speeds up drug approvals and saves resources, ultimately getting life-saving treatments to patients faster.
Recognizing the need for greater scalability and adaptability to evolving clinical development regulations, the client chose NIX as a reliable and experienced tech partner capable of providing both ongoing IT support and product enhancements.
Our collaboration began almost 20 years ago with just 4 dedicated specialists enhancing the client’s in-house team, and has grown to a team of over 70 across various roles, encompassing a full spectrum of IT support (levels 1-3) and development of new features for their core product.
By starting the integration of our dedicated team into the client’s workforce with detailed knowledge transfer, we quickly got up to speed for efficient system build, testing, and secure delivery of artifacts from the repository to the production site. We faced the following challenges:
The RIM platform needed to comply with diverse and constantly evolving regulations across different regions. This necessitated frequent system updates, ongoing monitoring, and rigorous, multi-layered testing to keep the product competitive and compliant.
The underlying architecture of the legacy code was inflexible and interconnected, posing significant challenges to updating and adopting new regulatory norms.
Along with the client team, we provide IT support services covering business hours in three time zones such as CET, PTS, and ETS.
Our IT team provides support to end users, analyzing their requests and identifying straightforward issues. We strive to resolve them right away, enhancing workflows for improved user interaction and satisfaction. For more intricate problems, our experts meticulously gather all relevant details, create a defect report for further investigation, and escalate the ticket to the third line when needed.
Product improvement requests are tracked, reviewed for feasibility, and implemented when approved. Security audits are carried out through third-party assessments and lead to necessary improvements for enhanced protection from our side.
Our initial workflow utilized Salesforce and HP Quality Center for ticket, defect, and test management. Lately, data management and system monitoring migrated to the ServiceNow ticketing system, Dynatrace, and AppInsights.
This level tackles resolving common, pre-defined problems with basic troubleshooting steps. We provided clear communication and knowledge of common issues to resolve problems quickly and efficiently.
Resolved issues: Reset passwords, locked accounts, error messages related to network connectivity, difficulty accessing files or folders, questions about using specific software features.
NIX’s support team provides reactive and advanced troubleshooting, remote diagnostics, and incident escalation. The NIX team analyzes process blockers in terms of complex error messages, logs, and system behavior, performs root cause analysis, and provides configuration management, optimizing performance and reducing downtimes.
Resolved issues: Troubleshooting connected with system restores and software rollbacks, user accounts and permissions management, backing up and restoring data, version conflicts, unexpected system behavior.
Our skilled team tackles complex issues on the deeper layers, managing 10+ applications and implementing modifications to system configuration. We analyze system crashes and errors with severe impacts on critical business operations and work with system logs and performance data to identify patterns and anomalies. By identifying root causes and implementing preventative measures based on a proactive approach, we not only fix immediate problems but also ensure long-term system stability.
Our level 3 support experts document their findings in the knowledge base for future reference, empowering all support levels for faster problem resolution across the board.
Resolved issues: Troubleshooting connected with logs, performance issues, anomalies, debugging complex software issues or hardware malfunctions, critical server errors, permission requests, misuse configurations, and security issues.
The team migrated the legacy Java 7 code to the modern Spring framework, including Spring Boot for easier maintenance. We boosted scalability by layering cloud microservices on Microsoft Azure for submission processing, rendering, publishing, and more.
Recognizing the evolving regulatory landscape, we developed APIs from scratch for smooth export and upload to other systems. For instance, NIX implemented Identification of Medicinal Products (IDMP) standard for automatic drug terminology extraction, and integrated Power BI to provide comprehensive regional and statistical reports. This comprehensive architecture streamlines data flow, simplifies management, and enhances security.
The global pharmaceutical industry is very stringent in terms of regulations, both for pharmaceuticals themselves and software development. Each region boasts its own regulatory body with unique specifications that are constantly evolving. This requires continuous monitoring and adjustments to the platform’s branched business logic. NIX experts provided the platform compliance with FDA (North America), EMA (Europe), PMDA (Japan), MHRA (UK), and CNMP (China). Beyond regional regulations, the product has also to stay updated on standards like ICH, eCTD, IDMP, xEVMPD, 21 CFR Part 11, and GCP.
The NIX team followed the ISO and FDA quality standards, guaranteeing the product operates at the highest quality standards due to mitigating risks across the entire development life cycle, detailed documentation, and data security prioritization.
We implemented the following integrations to unify the information environment and streamline workflows :
NIX’s IT support and development services help the client significantly grow their product, ensuring system stability, extensive functionality, and great performance. As a result, the platform became one of the market leaders—now it’s used by 50+ businesses, 10 of which are among the top 20 pharmaceutical companies in the world. Our IT support team acts as a bridge between users and developers, fueling continuous product improvement through user feedback and suggested enhancements. Our expertise, proactive approach, and complex understanding of the client’s needs has led to the long-standing partnership contributing to the client’s success.
100+
IT Support cases processed per month
10k+
Number of users
500k+
documents processed a year per one B2B user on average
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