The CRO landscape continues to shift and grow, continually increasing global clinical development market share with a wide spectrum of outsourcing services and models available to biopharmaceutical companies. The way we source has rapidly outpaced the terms we use to describe and define it, creating a need for a new industry-wide framework to better understand and engage these models. ICON, with Tufts CSDD and a consortium of pharmaceutical partners, have researched and proposed a new framework which we can use to benchmark the efficacy of certain models.
The CRO landscape has changed significantly in the last few years, with considerable shifts in market share as CROs mature and major evolution in the way we work. According to the Tufts Center for the Study of Drug Development (CSDD) Impact Report for November/December 2022, the CRO market continues to grow with nearly $50b of total spend in the drug development industry allocated to contract clinical services. Nearly 60% of global spending in clinical development is for outsourced services, and that percentage is growing faster than that of the non-outsourced areas of clinical development spending.
Demand for CRO services has steadily grown and it’s expected to continue. This demand is attributed to the increase in smaller biopharmaceutical companies and virtual biotechnology companies with limited internal capacity, the leaner sponsor operating models and the continuous strategic shifts that larger biopharmaceuticals make to maximise their ROI through the balance of in-house competencies and outsourced expertise. As sourcing models have become more complex to fit the market demands and capabilities, the original dichotomy of Full-Service Outsourcing (FSO) and Functional Service Provider (FSP) models has become rife with ambiguity. To paint a fuller picture of the current CRO and sourcing landscape, we need more accurate terminology suitable to the new ways we contract this work.
Outpacing old definitions and outlining new ones
The way we work has rapidly outpaced the terms we use to describe and define it.
As sponsor company operating models have continued to evolve and adapt, the terminology and definitions we use to discuss these sourcing strategies have remained unchanged for nearly twenty years. The original definitions of FSO and FSP have not been adapted and terms like “full service” are commonly used as a generic catch-all, stretched to cover a growing industry and adding to the confusion and uncertainty. Sponsor companies have attempted to differentiate their outsourcing practices, but the increasing complexity in clinical projects and within the often large and fragmented companies themselves has prevented a standardised terminology.
The underlying differentiators across the various iterations of the FSO and FSP services is really the level of employment of the CRO’s infrastructure, processes and standard operating procedures (SOPs). Depending on the size, configuration, portfolio and in-house capacities of sponsor companies, different models or combinations of models may be utilised. Based on this reality, we have proposed a new framework to provide clarity in characterising sourcing models that accounts for the variety in responsibilities and accountability across sourcing models.
![13449-006-Whitepaper-blog-content-draft_300-(1) 13449-006-Whitepaper-blog-content-draft_300-(1)](https://icon.widen.net/content/qsgig0djjl/web/13449-006-Whitepaper-blog-content-draft_300-(1).jpg)
This new framework better categorizes the full spectrum of CRO services supporting clinical trials and - as featured in the Tufts CSDD Impact Report — enables more meaningful analysis and comparison of outsourcing approaches and their impact on drug development performance.
Building benchmarks
Industry-agreed terminology and sourcing frameworks are key to developing benchmarks for the effectiveness of sourcing models, either as singular models or a combination. ICON collaborated with Tufts to research and develop this new framework, and we leveraged our relationships with 18 of our biopharmaceutical company Partners of Choice to garner real-world input and capture the breadth of sourcing models used by some of the top companies. From this framework, we can create consistency in terminology across the industry which we can utilise to better evaluate the value propositions of each model across the lifecycle of a development project.
To further this research and benchmark the various permutations of sourcing models across the industry, we are engaging with Tufts CSDD and our network of biopharmaceutical Partners of Choice to conduct primary research comparing clinical trial performance outcomes. Benchmarking these sourcing models and strategies within a well-defined framework of terminology will clarify sourcing expectations and facilitate improved decision-making for selecting the most effective model for each development project.
Concluding comments
The diversity of sourcing models and increasing demand for CRO services necessitates updated, accurate terminology to guide decision-making and establish improved expectations based on model definitions. ICON, along with Tufts CSDD and a consortium of our Partners of Choice, have collaborated on a new framework to differentiate these sourcing models and enable a more granular analysis of each. As CROs grow in size and market share, and as clinical development spend continues to rise, CROs are also keen to improve their productivity. Redefining how we work with industry-accepted terminology and utilising a framework for understanding sourcing methods will avoid confusion, ensure common understanding between partners and across the industry regarding responsibilities and accountabilities and enrich our insight into clinical trial performance.
Read more about our framework for characterising sourcing models in our Redefining CRO sourcing model terminology to optimise outsourcing strategies article or the Tufts CSDD Impact Report November/December 2022 issue.
To learn more about ICON Strategic Solutions, and how we can help you with the clinical development process, visit us at https://www.iconplc.com/fsp.
In this section
-
Digital Disruption
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
-
Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Flexible delivery models
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel