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Externalised development services
Redefining drug development partnership
Pharma and biotech sponsors often need a partner that can streamline strategy, reduce friction and maintain asset knowledge throughout the development lifecycle.
ICON’s externalised development model unifies nonclinical expertise, strategic consultancy and clinical delivery within a flexible framework adapted to each sponsor’s resourcing needs.
End-to-end capabilities
Nonclinical strategy and oversight
Senior toxicology, pharmacology and DMPK experts support candidate selection, IND strategy, CRO oversight, regulatory documentation and early de‑risking across all major therapeutic areas and advanced modalities.
Drug development consultancy
More than 50 senior specialists provide translational planning, regulatory strategy, clinical development design and evidence strategy to help sponsors navigate key inflection points and optimise programme decisions.
Clinical operations and delivery
Integrated operational leadership delivers Phase 1-3 studies with connected data management, biostatistics, medical oversight and decentralised solutions, maintaining strategic alignment from early development to pivotal trials.
Commercial and market access alignment
Payer‑centred evidence planning, RWE and health economics expertise ensure programmes anticipate commercial requirements and support long‑term value.
A partner that is an extension of your team
ICON operates a modular approach that can fully externalise development or integrate seamlessly alongside your teams. Standardised governance, secure data architecture and an asset‑centric mindset preserve institutional knowledge and ensure programme continuity.
Demonstrated impact
- Integrated scientific, operational and regulatory expertise across the full development continuum
- Asset‑centred approach that reduces internal burden and enhances decision quality
- Proven track record in accelerating timelines and improving value outcomes
In this section
- Consulting and advisory services
- Asset Development Consulting
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Blended Solutions
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Cardiac Safety Solutions
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Clinical & Scientific Operations
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Accelerated study start-up
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Biostatistics and Programming
- Clinical Operations
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Data Monitoring Committee Services
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Clinical Supplies Management
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Clinical data science
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Endpoint Adjudication Services
- Global Logistics
- Interactive Response Technology
- Investigator Payments
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Medical Affairs
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Medical Call Centre Services
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Medical Writing
- Pharmacovigilance
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Project and Program Management
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Accelerated study start-up
- Commercial Positioning
- Decentralised Clinical Trials
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Early Clinical
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Bioanalytical Laboratories
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Biometrics
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Clinical Pharmacology
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Clinical Research Facilities
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Early Phase Oncology
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Ethnic Bridging Studies
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Manufacturing & Pharmacy Services
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Medical Affairs
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Early Phase Patient Studies
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Early Phase Obesity Trials
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Quality and Compliance
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TQT studies
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Quantitative Pharmacology and Pharmacometrics
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Healthy Participant Recruitment
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Bioanalytical Laboratories
- Language Services
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Laboratories
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Bioanalytical Laboratories
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Applications
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Technologies
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Flow Cytometry
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LC-MS/MS
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Ligand Binding Assays
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qPCR
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Liquid Scintillation Counting (LSC)
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Technologies
- AI at ICON
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WorkBench
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LabView360
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CARD
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Signet
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ARCADES
- FIRECREST
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ICON Digital Platform
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OneView
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ICON ORCA Safety
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Evidence Platform
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Control Tower
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FLEX ADVANTAGE
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Medical Imaging Technology
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ICON ORCA Safety
- NONMEM
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Clinical Data Studio
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PDx-POP
- PubsHub
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SIMS
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ICOMaster for eTMF
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Prism Connect
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SmartDraft
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HORIZON
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Flow Cytometry
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Central Laboratories
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Specialty Biomarker Laboratories
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Laboratory Facilities
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Biomarker testing portfolio
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Biospecimen Services
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Biotech Laboratory Solutions
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Bioanalytical Laboratories
- Medical Imaging
- Outcome Measures
- Real World Solutions
- Regulatory Affairs
- Symphony Health data
- Site & Patient Solutions
- Strategic Solutions