“The life sciences sector is poised for a dynamic year in 2025, with significant developments expected in M&A, PE investments, capital markets, AI, and regulations”, as the experts from Goodwin and KPMG said at the beginning of this year .  Dynamic years lead to exceptional opportunities, as AROBS enabled a client’s growth strategy by integrating an acquired solution. The client had acquired a company offering an innovative clinical trial asset management system already used by top pharmaceutical companies, therefore having significant potential to expand its market reach.

Pain Point: The newly acquired solution required comprehensive regulatory validation to meet global compliance standards before expanding the client base and safely onboarding existing portfolio clients to the market.

Before onboarding more clients, the system needed to satisfy strict requirements (FDA, EMA, etc.) for data integrity and patient safety. Pharmaceutical compliance is a high-stakes arena: a single compliance misstep can incur substantial remediation costs.

Solution

AROBS assembled a specialised validation task force that combined deep regulatory expertise with seasoned QA professionals. Following a modular validation approach, the team divided the software into functional modules and reviewed each against regulatory requirements. Any gaps between the system’s current state and compliance standards were identified and prioritised. The team then executed a comprehensive re-validation of the entire solution in record time, ensuring that every module (e.g. data handling, audit trails, user access controls) met or exceeded global Good Clinical Practice (GCP) and 21 CFR Part 11 expectations. Throughout this process, AROBS’s experts collaborated closely with the client’s quality and regulatory staff to incorporate industry best practices and to document compliance evidence for auditors.

Execution

AROBS managed the end-to-end validation project, delivering a globally compliant, market-ready product. In addition to core validation, AROBS developers implemented enhancements, including integrating the platform with the client’s existing software ecosystem, updating branding, and adding custom features required for new markets (such as multi-language support and region-specific regulatory reports). The modular approach enabled efficient gap analysis and remediation without compromising the overall integrity. Each update was tested to ensure there are no regressions elsewhere. This phase-by-phase execution guaranteed that the solution achieved full compliance with FDA, EMA, and other international regulations. By the project’s end, the client had complete confidence that the acquired system could be rolled out to both existing and new pharmaceutical clients safely and in compliance with all applicable standards.

Team Profile

The project’s success was driven by an agile team blending domain and technical skills. AROBS team was created by regulatory compliance specialists (experienced in life sciences and clinical trial regulations) and senior QA engineers with pharmaceutical software development experience. Complementing them were integration developers skilled in both the legacy and modern technologies involved, ensuring smooth connectivity and data migration. Overseeing the effort were experienced project managers who had previously led M&A software integrations, bringing strategic insight into aligning the acquired product with the client’s broader portfolio. This combination of talent enabled the team to rapidly comprehend a complex, legacy clinical trial system and efficiently transform it without stumbling into common pitfalls.

Result

The solution was successfully transformed into a market-ready, globally compliant product within the targeted timeframe. This enabled the client to confidently proceed with onboarding new customers and migrating its existing portfolio clients onto the platform.

Thanks to AROBS’s thorough validation and scalable team model, the client minimised compliance risk while controlling costs; the flexible resourcing ensured cost-efficiency aligned with the project’s phases.

Our partner has unlocked an unprecedented market expansion opportunity: the client is poised to grow its business footprint in response to the growing demand for clinical trial management systems, a global market projected to reach USD 6.60 billion by 2034, expanding at a CAGR of 12.57% from 2025 to 2034. The client gained a competitive trust advantage in an industry where compliance is paramount.