2020 is proving to be a year to remember, with the healthcare industry navigating through difficult circumstances and the unknown around COVID-19 to continue drug development for patients in need. But, in many ways, we could just add these challenges to the ongoing list of trial complexities that have helped fuel the continued increase in cost for clinical development. The pressure is on for the pharmaceutical industry to reduce cost and improve speed of treatment development while keeping up with ever-changing regulatory updates and increasing competition. And, as trends show the cost of drug development outstripping revenue growth, this is more critical than ever.

Amid a complex trial landscape, heavy focus on specialized treatments in developed markets, patient-centric digital health integration, and more, change is coming to a head for the industry. Whether already contracting for functional service partnerships or considering them, an increasing number of companies are evaluating their outsourcing strategies to further enhance clinical operations, data sciences, and safety or regulatory components of drug development.

The need for enterprise-wide transformation

Over the years, the use of Functional Service Provider (FSP) outsourcing solutions has increased among large, multi-national pharmaceutical firms to mitigate growth in fixed cost and derive flexibility in resource management.  Use of traditional approaches to FSP outsourcing can lead to as much as 15 percent in savings compared to hiring full-time employees. Traditional models for FSP outsourcing typically rely on multi-vendor approaches to resource provision, siloed by functional capability (e.g., data management, clinical monitoring, and statistical programming) and geography. And, often, these models use the company’s internal processes and systems to support completion of the work performed by the third party resources.

Though intended to support and enhance efficiencies within the functionally-aligned components of a company, FSPs may also need to evolve and go well beyond siloed flexible staffing solutions to deliver additional efficiency, speed, and precision to cope with the challenges facing the industry.

Considering focused shifts

Currently, FSP models can help decrease the cost of labor, but recent innovations in automation to leverage artificial intelligence, machine learning, and advanced analytics can actually help reduce the effort required to perform certain tasks.

Removing effort while simultaneously focusing on enhanced quality and predictability through data-driven insights is contributing to significant efficiencies in some labor-intensive segments of the clinical development enterprise. For example, it is well-known that clinical monitoring can make up as much as 35 to 45 percent of total costs for a clinical trial. Powerful centralized monitoring solutions can be a cornerstone of an up-to-date FSP approach and can help cut these costs and improve overall effectiveness. A clinical research organization partner capable of providing a centralized solution with real-time data analytics and AI/ML-enabled workflows can help study teams more efficiently improve data quality, ensure site compliance, and stay on top of patient and site risk management. At IQVIA, this advanced approach to clinical monitoring is fueling a transformation of clinical operations, removing up to 40% of effort required historically as on-site monitoring visits.

When evaluating how new FSPs can create efficiencies, it is worth considering a larger discussion with FSP partners that asks what core components of clinical development the company needs to own, and what can be taken on better by valued third-parties. In flushing out collaborative efforts to meet the demands of future drug development, it is proper to not only look to FSPs for staffing solutions but also to leverage and integrate their resources and technologies, including comprehensive SaaS-based platforms, which can further streamline processes toward efficiency and precision — not work in parallel to them.

The earlier in the strategy and design process that sponsors can involve and engage FSP partners, the better. Co-designing solutions for individual customers based on their specific business objectives from the start can help identify all of the potential capabilities and tech-enabled solutions that may bring benefit: opportunities to increase efficiencies in a specific function, geography, and other functional components that integrate to most effectively execute clinical trials.

Reducing inefficiencies that cost time and money and keep patients waiting for therapies they need has always been a challenge for clinical development. Now, the industry is better equipped with innovative solutions and capabilities to overcome this challenge. And, as we live through the effects of a global pandemic, it may be the ideal time to push ourselves harder for renewed thinking about how to collaboratively improve the design of FSPs to more efficiently meet business objectives and patient needs for innovative medicines.
 

Since joining the pharmaceutical industry in 1982, Michael has garnered experience in a variety of leadership roles spanning a multitude of clinical development disciplines including Product Development, Clinical Operations, Regulatory Affairs, Information Systems, Quality, and Compliance.