A major European pharmaceutical company with a significant presence in the US market faced operational challenges as it expanded its global footprint. The client was at a critical juncture, launching new products and scaling up clinical trials while grappling with complex IT support needs across multiple international locations. To help transform their operations, they formed a strategic partnership with us, for our extensive experience and expertise in IT modernization.
The Challenge
Fragmented systems and global scaling complexities
The pharmaceutical giant was struggling with multiple complex challenges that were hampering its growth and operational efficiency.
- Inefficiencies and communication gaps due to multiple vendors leading to disjointed IT support across different tiers (L1/L2/L3) of technical support
- Difficulties in implementing IT support in operations spanning 7 locations across Europe, Asia and the Americas
- Scaling issues for new product launches and expanding clinical trials due to lack of infrastructure to handle increasing volumes of calls, adverse events and regulatory submissions
- Limited experience with Medical Communications Center (MCC) and Pharmacovigilance (PV) regulations
- Difficulty in meeting strict regulatory compliance requirements such as Good Practice guidelines (GxP), International Council for Harmonisation (ICH), Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR)
- Budget constraints amidst the need for operational expansion
The Objective
Consolidate IT support, improve service quality and enhance compliance
The company's primary objective was to overhaul its IT support structure and boost operational efficiency. This involved consolidating fragmented IT support into a unified system to improve response times and resolution rates across Application Service Delivery (ASD) and Global Service Delivery (GSD). Simultaneously, the company sought to bolster its regulatory compliance measures to meet the stringent requirements of the pharmaceutical industry. As the business expanded, there was a pressing need to scale operations effectively to handle the increasing volumes in clinical trials and post-market surveillance activities. Underlying all these objectives was the critical task of optimizing costs while elevating service quality and balancing fiscal responsibility and operational excellence.
The Solution
Strategically implementing solutions to attain business objectives
Our comprehensive approach was designed to provide seamless, multilingual support while ensuring strict regulatory compliance and scalability for future growth.
- Established a centralized IT technical support desk for L1/L2/L3 support, replacing the previous multi-vendor system
- Set up global support centers in strategic locations including India, China, Bulgaria, Denmark, the US and Brazil to provide 24/7 coverage
- Deployed multilingual support staff, ensuring effective communication across all markets
- Provided on-site technicians across eight countries – Denmark, the US, China, Japan, Korea, Norway, the UK and Switzerland
- Took over MCC operations, PV services and clinical application support
- Implemented robust compliance systems to ensure adherence to all relevant regulations, including regular risk assessments and audits
- Designed scalable infrastructure to handle growing volumes, with the flexibility to add resources as needed
- Focused on industry best practices and continuous improvement
The Impact
Achieved $700K+ annual savings in MCC operations
The transformation yielded significant and far-reaching benefits across the organization – dramatic improvements in operational efficiency, substantial cost savings, enhanced regulatory compliance and increased business growth. They also gained a positive reputation, resulting in industry referrals. The new operational framework not only resolved immediate challenges but also positioned the company as a leader in operational excellence within the pharmaceutical industry.
- Increased IT incident handling from 3,000 to 25,000 per month
- Staff productivity improved due to faster IT issue resolution
- Consolidated services led to over $700,000+ annual savings in MCC operations
- Successfully passed audits with zero non-conformities
- Enhanced regulatory compliance capabilities
- Supported new product launches and clinical trial expansion
- Improved organizational agility and decision-making capabilities