PPD Functional Service Partnership (FSP) Feasibility Solutions
The expertise you need to overcome country and site selection challenges
As trials grow larger and more complex, biopharmaceutical, biotech and medical device organizations need help reducing the uncertainties and inefficiencies of traditional feasibility and site selection – critical factors for clinical trial success.
PPD™ FSP Feasibility solutions help biopharmaceutical, biotech and medical device organizations identify trial design considerations and perform country and site selection activities. Using a flexible functional service partnership (FSP) model, our team drives on-time delivery of studies by conducting comprehensive data-driven feasibility assessments based on your specific needs.
Whether you need support for early protocol planning, trial optimization, competitive landscape analysis, country and site strategy, enrollment benchmarking, or site selection, we apply bespoke services that scale to meet your needs – all while providing much needed resource flexibility, reliability and continuity.
Drive on-time study delivery with our customized solutions
Clinical trials are becoming larger and more complex, driving more competition for sites and patients. Study planning for country selection is often conducted with limited or no insights, resulting in startup delays and saturation of sites that struggle to enroll enough patients. As a result, more sites or extended enrollment durations are often needed, driving up study costs and delaying study completion.
PPD FSP Feasibility solutions are custom-fit and data-driven and include a comprehensive analysis of critical study components to best inform you according to your level of need. Our feasibility solutions encompass some or all the following services to help you across your protocol development journey:
PPD FSP Feasibility solutions analyze both proprietary and external data sources to build a baseline operational strategy and identify risks and challenges to the protocol concept. Easy-to-digest visuals clearly explain the data.
PPD FSP Feasibility solutions integrate multiple proprietary tools, data sources and subject matter experts to develop an optimal, patient-centric plan to enable seamless program delivery, regulatory success and market access. We deliver optimal trial analysis and recommendations.
PPD FSP Feasibility solutions employ a data-driven approach to comprehensive site selection assessments using proprietary and external resources, tools and vendors in combination with local feasibility intelligence. Pre-study assessments may also be implemented and conducted on a rolling basis with the feasibility assessment to expedite study startup.
Leverage innovative new survey processes to drive on-time study delivery
We have developed two new industry-changing survey processes as alternatives to the traditional confidentiality disclosure agreement (CDA)-first model:
Data-driven feasibility triangulates data from site, patient and landscape sources
Our data-driven feasibility solutions are unlike any other. We go beyond traditional data sources, using expert data analysis powered by artificial intelligence (AI) algorithms to synthesize data across multiple platforms — including proprietary and external data sets — producing the kind of insights that meaningfully improve the quality of critical early decisions. The result is a tailored and unique strategy that plays a pivotal role in shaping the trajectory of the remainder of the study — and the product’s life cycle.
Our approach meets the demands of planning for clinical trials today:
- Incorporating site performance data from external sources
- Patient population analysis
- Changing standards of care
- Direct site feedback
- Open-source epidemiology
- Dynamic clinical development landscape
- Site burden/needs
- Regulatory intelligence
- Diversity and inclusion criteria
- Trial congestion
- Patient burden
- Other datasets
We combine our unrivaled proprietary data with external sources to provide the most comprehensive view of patient, site, industry and investigator data to optimize patient enrollment and site selection. As an early adopter in translating data into real-world insights, PPD FSP Feasibility solutions perform analytics and predictive modeling to recommend the optimal site-country mix to generate enrollment and timeline projections.
We leverage a mix of internal and external data sources
Preclarus®
Our global proprietary clinical trial and investigator database, which contains more than 5,000 studies and more than 180,000 sites in over 100 countries including data from clinical, central labs and patient recruitment services; most sites include historical recruitment data, cycle-times, site type and contact details.
AES
Our owned and staffed network of over 180 sites on four continents across 15 countries, (including more than 50 dedicated research sites dedicated exclusively to clinical trials), often delivers more patients from fewer sites. All sites have the capacity to identify actual patients in a proprietary database with de-identified, pre-identified and fully identified patient data to precisely predict enrollment numbers and costs.
PPD Select
Our global site relationship program with top-performing networks, sites and investigators spanning more than 40 countries provides access to over 3,300 sites.
TrueCast
The industry’s largest historical site performance database. AI-powered predictive analytics leverage our data and Medidata data generated from over 26,000 clinical trials and nearly 8 million patients in more than 140 countries to:
- Identify optimal countries and sites balancing speed, cost and quality
- Predict site activation timeline and patient enrollment curves at the study, country and site levels
- Compare scenarios to select the best design
- Benchmark industry performance on similar trials, same phase, indication and patient population
PPD OncoLocator
Treatment data for 25 cancers in the top 10 pharma markets provides real-time understanding of treatment patterns in common cancers.
TriNetX
Provides real-world electronic medical records (EMR) data and insurance data for millions of de-identified patients around the globe.
Citeline
(TrialTrove, SiteTrove, Pharma Projects, DataMonitor Healthcare)
Trial intelligence compiled from more than 60,000 sources provides databases that enable detailed searches and analyses for competitive landscapes, data for benchmarks and metrics, patient populations, institution and investigator ranking, and more.
Evaluate Epi database
Detailed patient segmentation data covering over 500 diseases and more than 14,000 sub-populations provides comprehensive global epidemiological data to assess disease prevalence in a potential country by patient segment.
Inato
Offers access to more than 2,000 community sites to help broaden the site footprint, offering lower competition/saturation and greater diversity as compared with “traditional” sites.
Because our feasibility solutions are delivered as an FSP engagement, we offer a flexible mix of systems, processes, oversight and tools – yours or ours – and may incorporate your data as part of our solution.
Delivering the breadth and depth of feasibility expertise you need
Experience matters. That’s why biopharmaceutical, biotech and medical device organizations rely on the PPD™ clinical research business of Thermo Fisher Scientific to deliver custom-fit, data-driven feasibility solutions.
The PPD FSP Feasibility solutions team has experience working across all aspects of feasibility from early engagement protocol planning and optimization, competitive landscape analysis, country and site strategy, and enrollment forecasting through site outreach, qualification, and selection. Our team comprises Feasibility Managers, Strategists and Site Specialists focused on executing unique feasibility strategies designed around each individual project.
Local experts are particularly crucial when “non-footprint” countries (where you might lack experience or a physical presence) are being considered. These regions, often found in emerging markets or remote areas, provide access to sites with less clinical trial activity and untapped patient populations, driving more consistent enrollment and heightened engagement from staff.
PPD FSP Feasibility solutions also leverage the functional expertise of the broader organization by collaborating with roles across our clinical research business, including medical, operations and regulatory affairs experts. For example, our physician/clinical scientists can provide medical input into surveys and provide their therapeutic, medical and operational expertise, our Global Site Contract experts help develop CDA processes and templates, and our patient diversity subject matter experts can serve as strategic advisors at the study level to support the delivery of inclusive strategies that ensure real-world representation.
The PPD FSP Feasibility solutions team also provides an option to collaborate with our Strategic Development Consulting (SDC) team, offering a unique and innovative approach to core components of asset development. With expertise in nonclinical (Chemistry Manufacturing Controls [CMC], toxicology, pharmacology) and clinical development, our SDC team provides integrated solutions customized to your goals. Comprised of experts in various fields, including CMC, toxicology, pharmacology, biostatistics, regulatory strategy and medical science, our consulting team brings decades of industry experience and full life cycle product development expertise to accelerate decision-making and maximize clinical evidence value.
Custom solutions to solve your specific feasibility challenges
Backed by more than 25 years of FSP expertise, we know what it takes to reliably provide customized solutions tailored to your specific needs. PPD FSP Feasibility solutions are delivered via either staff augmentation or variants of custom-fit engagements, including hybrid FSP/full-service outsourcing (FS0) arrangements. Our feasibility team also collaborates closely with other teams in our organization, with our customers and with sites to ensure a seamless transition to downstream services, driving on-time study delivery.
Because no two feasibilities are identical, our approach and staff and service deployments are dictated by project-specific needs, requirements and priorities. Whether you need help with protocol design or a feasibility assessment for a single trial or for multiple global trials across a diverse portfolio, we develop and implement bespoke services that scale to meet your needs.
For every relationship, we partner with you to personalize the outsourcing model. We also use innovative pricing models to accommodate various contract structures from full-time equivalent (FTE), unit-based, time and materials and hybrid models.
Our flexible models evolve over time to meet your specific needs as they exist at any given moment – key to a successful FSP relationship.