Over the course of more than a decade, Veramed has built a dynamic and enduring partnership with this global Top 10 pharmaceutical client, serving as a trusted FSP vendor since 2017 and providing biometrics support since 2012. Recognising the need for excellence in statistics and programming across Phase I-IV trials, the client sought not just a solution, but a strategic partner capable of delivering scalable expertise across geographies, including the U.S., U.K., Ukraine, and India.
Veramed’s tailored FSP approach combines innovative team augmentation, robust project management, and specialised consultancy, which has enabled the client to streamline operations and pursue cost efficiency without sacrificing quality. By delivering high–calibre statisticians and programmers as well as specialised services such as data anonymization and standards automation, Veramed has enabled the client to exceed its strategic objectives and maintain the integrity of its studies. This case study explores the collaborative journey and transformative impact of Veramed’s partnership, highlighting our commitment to elevating team quality and delivering measurable value.
The issue
Client A faced significant challenges in managing statistics and programming resources for their global Phase I-IV clinical trials. With existing in-house teams in India and partnerships with other vendors, the client struggled to maintain cost efficiency while ensuring the highest standards of quality and flexibility across their projects. Specifically, they encountered difficulties with scaling teams rapidly to meet fluctuating study demands, integrating expertise across multiple geographies, and maintaining seamless coordination between internal and external resources. There were also ongoing concerns about ensuring compliance, data integrity, and effective anonymization processes in a rapidly evolving regulatory environment.
Recognising that their current staffing supply chain was not fully meeting these operational and strategic needs, the client sought out Veramed for an alternative resourcing solution, one that could deliver cost reductions without compromising on calibre, enable smarter workforce deployment, and ultimately support their ambition to enhance project delivery and maintain scientific excellence.
The solution
To address the client’s complex challenges in managing global statistics and programming resources, Veramed implemented a systematic, tailored approach.
Assessment of Biostatistics and Programming Gaps
The first step was to assess the client’s operational bottlenecks and strategic gaps across their Phase I-IV clinical trials, including difficulties in scaling teams, ensuring flexibility, and maintaining quality standards internationally. Veramed responded by establishing a scalable delivery model, deploying up to 40 full-time statisticians and up to 120 full-time programmers as needed. These teams were integrated seamlessly with the client’s existing workforce across multiple geographies, including the U.S., U.K., Ukraine, and India.
Statisticians contributed to strategic responsibilities such as developing statistical models, overseeing vendors, introducing novel methodologies, and supporting both marketing and real-world evidence projects.
Programmers provided expertise in PK modelling, data science, and project delivery, while operating through flexible models—either as FTE augmentation or on a unit-based basis—depending on the client’s needs. To ensure confidentiality and data integrity, Veramed organised independent DMC support, utilising dedicated unblinded teams managed entirely within Veramed systems. This structure helped protect sensitive information and maintained compliance with evolving regulations.
The partnership was further strengthened through Veramed’s proactive identification of additional needs. The team introduced support for SDTM conversion, pharmacokinetics (PK) group modelling (for example, NONMEM), integration and submission report development, responses to regulatory queries, advanced data anonymization, and consultancy on standards and automation (such as DTM, SCE implementation). Veramed also expanded into Real-World Evidence (RWE) and publication support as new challenges emerged.
By following this strategic, stepwise deployment and continuously adapting services, Veramed enabled the client to optimise resources, increase flexibility, and maintain both cost efficiency and quality across all projects.
- Comprehensive assessment of needs and gaps
- Strategic and flexible team deployment
- Seamless integration with client operations worldwide
- Specialised support for compliance, data integrity, and regulatory requirements
- Expansion of services in response to emerging challenges
The outcome
By directly addressing the client’s initial challenges, namely, managing resource fluctuations, ensuring cost efficiency, and maintaining consistent quality across global clinical trials, Veramed’s tailored solutions enabled the client to overcome operational bottlenecks and strategic gaps.
The integration of high-calibre statisticians and programmers enabled rapid team scaling, seamless collaboration across geographies, and strengthened compliance and data integrity throughout Phase I-IV studies.
As a result, the client benefited from measurable cost savings, enhanced flexibility, and elevated standards of delivery. Veramed’s proactive approach, demonstrated by the addition of anonymization services, DMC support, and consultancy in automation and standards, has not only met but exceeded the client’s evolving needs, leading to successful project outcomes and reinforcing scientific excellence across their portfolio.
The client’s ongoing trust in Veramed has since led to the expansion of Veramed’s support to additional studies, transforming operational challenges into strategic advantages.
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