Clinical development continues to face increasing complexities, timelines and costs
Biopharmaceutical and biotech drug developers continue to face increasing challenges. Long-standing issues related to increasing complexities, timelines and costs in clinical development are nothing new, but recent trends indicate pressures are escalating, putting greater burdens on sponsors, sites and patients.
And the data supports this:
increase in patient participation burden.1
increase in the average time to complete a clinical trial.2
increase in the average cost to bring a new drug to market.3
As a result, drug developers face even more project delays, missed market opportunities, loss of patent protection, regulatory concerns and financial strain.
A single day of delay is worth approximately $500,000 in unrealized or lost prescription drug sales and $40,000 in direct daily clinical trial costs.4
of drug developers are using FSP or hybrid FSP/FSO (full-service outsourcing) solutions.5
Over the past two years, the use of FSP outsourcing has grown faster than FSO
▼
of drug developers increased their use of FSP.5
have increased their use of FSO.5
of sponsors are increasing their use of FSP.6
Not all FSP partners are created equal. Is your FSP partner equipped to:
Leverage flexible bespoke hybrid FSP/FSO arrangements to optimize clinical trial operations and meet your timelines.
Take a closer look at how the right resources, skills and training help deliver new FSP partnerships on time.
Discover several approaches to consider when implementing efficient FSP partnerships that are fit-for-purpose and poised for optimal performance.
Learn how the right FSP partner helps you improve operational speed and efficiency with follow-the-sun models and support in non-footprint countries.
Gain insights into the state of clinical development outsourcing and how sponsors are leaning into FSP models to better navigate areas of opportunity.
Learn how FSP models help you secure high-level talent while remaining flexible and efficient.
Explore how FSP models help biotech companies efficiently augment their clinical development needs to stay flexible and agile.
Learn how the right FSP partner provides dedicated roles to accelerate startup and efficiently deliver services on schedule.
Discover how the right FSP partner helps you stay on top of regulatory requirements so you can get to market on time.
PPD FSP solutions is the solution
Choosing the right FSP partner is key. The right FSP partner helps drug developers maximize speed and efficiency and employs new and innovative strategies to deliver programs on-time and on-budget.
PPD™ Functional Service Partnership (FSP) solutions help biotech and biopharmaceutical companies meet their timelines by delivering the best of the best: hard-to-find, top-tier staff with a proven track record of reliably delivering clinical development and post-marketing services.
Because you can’t always predict—or find and retain—the staff and services you need, our experts provide outstanding therapeutic and functional expertise, uniquely positioning us to deliver the right experience and knowledge to fill immediate resource and capability gaps.
And to ensure projects launch on time and stay on budget, we employ dedicated transition and implementation roles and processes for swift deployment of staff and services, transparent communications, and proactive problem-solving.
With more than 30 years of support for clinical and marketed products, we know what it takes to solve your specific challenges. Whether you need to fill small gaps in services or outsource multiple functions across a portfolio, we deliver customized solutions tailored to your needs to provide much-needed resource flexibility, reliability and continuity.
Ready to leverage speed and efficiency to meet your timelines? Let’s connect.
Sources
1 Tufts Center for Drug Development, JAMA, Deloitte, Institute for Human Data Science
2 Tufts Center for Drug Development, Association of Clinical Research Organizations, Journal of Society for Clinical Trials
3 Tufts Center for Drug Development, PhRMA
4 How much does a day of delay in a clinical trial really cost?, June 2024, Applied Clinical Trials, Ken Getz, Executive Director and Professor, Tufts University School of Medicine
5 The Pulse 2024, Global R&D Insights in Pharmaceuticals, PPD Report
6 Complex CRO Environment: Looking at Cascade of Trends – Mega to Macro to Micro, January 2025 Jefferies report