Early Clinical
Early phase development services that will enable informed decision making for your drug development programme.
Global Clinical Research Units
ICON has a large early phase clinical research network with 6 state-of-the-art facilities in North America and the Netherlands. Each clinic is supported by the expertise required to successfully deliver the most complex of healthy volunteer, patient, or hybrid first-in-human and proof-of-concept studies.
Innovative early clinical solutions that will advance your drug development strategy
ICON is committed to the highest standards of excellence and scientific expertise in early clinical drug development.
We have extensive experience in the design, conduct, and interpretation of Phase 1/1a/proof of concept studies, providing the full suite of clinical pharmacology studies, all elements of a regulatory package programme, and translational early efficacy indication solutions in a range of study types including:
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ICON’s early clinical services deliver full visibility and control to meet the requirements of increasingly complex clinical trial requirements. Our dedicated early phase specialists will engage with you to develop a trial that is best for your compound. Together we will build a tailored approach that leverages our clinical pharmacology expertise, extensive research facilities, early phase operational experience, and biometrics capabilities to conduct your trial within both healthy volunteers and patient populations.
Our range of dedicated early phase clinical development services include:
- Clinical PharmacologyWe help design a protocol that works harder and smarter for you.
- CMCA one stop drug development solution that is perfectly suited for early phase trials with shorter timelines.
- Bioanalytical and Biomarker LaboratoriesSupporting rapid in-house simple analysis with method development, assay validation and specimen analysis.
- Clinical Research UnitsNetwork of ICON-owned clinics with the ability to deliver the most complex of healthy volunteer, patient, or hybrid first-in-human and proof-of-concept studies.
- BiometricsSpecialised data management, programming, biostatistics and medical writing services
- Early Phase Patient StudiesCustomised solutions designed to evaluate clinical endpoints and biomarkers within a smaller sample of patients to provide you with reliable proof of concept data.
- NONMEM SoftwareNONMEM is the gold standard software in Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic modeling. It can be used to fit models to many different types of data.
- PK/PD Pop SoftwarePDx-Pop software seamlessly integrates with existing tools and its own automated methods to expedite the iterative process of population pharmacokinetic modeling and analysis.
- Precision Methodology Cardiac AssessmentWe can serve your early phase testing needs with breakthrough methodologies and proven expertise in high-precision ECG data collection.
Clinical Pharmacology
We help design a protocol that works harder and smarter for you.
CMC
A one stop drug development solution that is perfectly suited for early phase trials with shorter timelines.
Bioanalytical and Biomarker Laboratories
Supporting rapid in-house simple analysis with method development, assay validation and specimen analysis.
Clinical Research Units
Network of ICON-owned clinics with the ability to deliver the most complex of healthy volunteer, patient, or hybrid first-in-human and proof-of-concept studies.
Biometrics
Specialised data management, programming, biostatistics and medical writing services
Early Phase Patient Studies
Customised solutions designed to evaluate clinical endpoints and biomarkers within a smaller sample of patients to provide you with reliable proof of concept data.
NONMEM Software
NONMEM is the gold standard software in Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic modeling. It can be used to fit models to many different types of data.
PK/PD Pop Software
PDx-Pop software seamlessly integrates with existing tools and its own automated methods to expedite the iterative process of population pharmacokinetic modeling and analysis.
Precision Methodology Cardiac Assessment
We can serve your early phase testing needs with breakthrough methodologies and proven expertise in high-precision ECG data collection.