Drug development is inherently risky. For biotech companies operating with limited resources and tight budgets, the risks – and the stakes – are even higher. Small biotechs that lack the internal infrastructure and the financial cushion to absorb setbacks are especially vulnerable to the risk of failure or delays at any stage. This is where the expertise of a large CRO becomes invaluable.
Partnering with a large, full-service CRO in an end-to-end capacity can provide seamlessly integrated support in both drug development and strategy, minimising risk while maximising ROI to make the most of biotech cash runways. Beyond the technical operational advantages, large CROs can also provide business support and vital network connections, helping biotechs bolster their executive capabilities.
Optimised strategy and operations
De-risking complex programs: For small biotech companies that are resource-constrained, outsourcing to a full-service CRO allows them to spread the risks and leverage the operational excellence of an experienced partner. As clinical trials become larger, more expensive and more complex, the greater breadth of capabilities and depth of expertise offered by a large CRO maximises the probability of success for biotech when the margin for error is small.
Strategic insight: The best risk mitigation is a clear, comprehensive strategy that allows biotech to “go big early” and progress through key milestones faster. CROs can assist with strategy development to set biotech programs up for success, leveraging insights gained from experience in clinical development across different therapeutic areas and modalities. By identifying potential roadblocks early in the process, CROs can help biotech companies prepare for and mitigate risks, ensuring smoother clinical trials, faster regulatory approvals and optimal commercial positioning. For a small biotech, these proactive measures can mean the difference between success and failure.
Continuity and vendor consolidation: With the CRO as a single point of accountability, multiple services can be managed through one partnership, scaling to fit specific needs and providing continuity throughout development. End-to-end support reduces the risk of operational delays or miscommunications and means biotech don’t have to juggle separate scopes under fragmented, ad hoc outsourcing strategies. Early engagement with a holistic partner streamlines delivery, mitigates risks and maximises resource efficiency—critical factors for smaller biotechs operating under financial constraints.
Intelligent solutions
Advanced technology infrastructure: Efficiency is key when operating on limited budgets. Full-service CROs offer cutting-edge technology solutions, data management systems, and operational infrastructure that smaller companies may not have in-house. By partnering with a CRO that has invested in a comprehensive ecosystem of digital solutions, small biotechs can tap into the benefits of these tools without having to invest their limited funds into their own infrastructure. This includes tools for clinical trial management, real-time data analytics, and patient recruitment technologies, which can enhance the efficiency and quality of trials.
Specialised expertise: Multidisciplinary and specialised expertise at your fingertips, including regulatory, clinical, operational and therapeutic experts. This cross-functional approach provides deeper insight and helps align different aspects of the project for clearer strategy, smoother execution and fewer bottlenecks. For example, biotech working with ICON have access to key teams like:
- Centre for Paediatric Clinical Development
- Expert nonclinical consultants
- Regulatory affairs
- Integrated medical imaging
- Harmonised laboratory solutions
Partnership as a resource
Broader ecosystem connectivity: Large CROs often have relationships with regulators, patient advocacy groups, key opinion leaders (KOLs) and academic institutions. Strategic collaboration with these CROs affords access to these networks, which can accelerate patient recruitment, strengthen regulatory submissions and enhance clinical trial designs.
Access to partnership networks: CROs with large networks can help small biotechs identify other potential partners (e.g., investors, large pharmaceutical companies) or licensing opportunities, potentially speeding up commercialisation or expanding development opportunities. At ICON, our experience with biotech development and large pharmaceutical companies, coupled with our strong network of investment banks and venture capital firms, also provides unique insight into how to build value into biotech asset development.
Above and beyond with dedicated biotech development
ICON has established a team of more than 8,000 passionate personnel dedicated to biotech. With ICON Biotech your wins are our wins, which is why we go above and beyond to fulfil the unique needs of small and emerging biotech partners, whether that includes assistance with fundraising, strategic planning and go-to-market strategies, or bolstering executive capabilities to help position your company for long-term success.
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Instrumental in securing millions of dollars in grant funding for our biotech partners
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Identified C-suite and specialist personnel to fill critical biotech company roles
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Identified best vendors for studies then developed and reviewed reports
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Recently led multiple Scientific Advice meetings on behalf of biotech partners
Unlocking biotech potential through strategic CRO partnerships
For small biotech companies, partnering with a large, full-service CRO isn’t just about outsourcing drug development tasks — it’s about building a strategic relationship to optimise their program within their funding constraints. By providing both operational and business support, the right CRO partner can be the catalyst for a biotech’s growth, enabling them to deliver on the promise of their science and bring innovative therapies to market faster, safer and more efficiently.
Visit us in Stockholm, Sweden at the 2024 BIO-Europe conference 4-6 November or connect with us to learn about the benefits of having ICON as your trusted biotech asset development partner, supporting you from molecule to medicine.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption whitepaper
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
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Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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