Early Phase
As dynamic as it is demanding
Initial human data are a critical milestone on the drug development journey.
For more than 25 years, our specialized Early Phase team has been dedicated to customizing solutions for navigating this challenging phase.
Customized solutions, from start to finish
From first-in-human to drug-drug interaction, from renal/hepatic impairment to proof-of-concept studies, we’re able to conduct any preclinical, Phase I to Phase IIa studies including: first-in-human (FIH), proof-of-concept, bioavailability/bioequivalence (BA/BE), drug-drug interaction (DDI), organ impairment, thorough QT (TQT), biosimilar, and numerous pharmacokinetic (PK), single ascending dose/multiple ascending dose (SAD/MAD) studies.
We also have robust experience with an array of investigational products (IPs), including those of biological origin, and with multiple delivery methods. In addition, we have access to specific patient populations including Japanese, Chinese, and patients who are obese or elderly.
Our experience encompasses:
No form 483’s issued in our clinics
External site collaboration network in Asia-Pacific/European Union/North America
We work as an extension of your team, providing tactical options customized to your asset’s early development, guiding you to proof-of-concept swiftly, with a meaningful exit.
Specialized expertise to meet any challenge
- To support decision-making on the next steps of your drug development program, our Pharmacometrics group provides data extraction capabilities for all of your quantitative modeling and analysis needs.
- Our dedicated Biometrics team provides a full range of services including clinical pharmacology, data management, statistics, medical writing and regulatory consulting.
- Our Bioanalytical Solutions team offers more than 1,200 assays ready to be used, making Syneos Health® a Top 3 global provider of bioanalytical capability.
Flawless execution and planning for what comes next
We take an evolved, multi-disciplinary approach to Early Phase clinical development. We rigorously focus on operational excellence but are able to engage experts in product development strategy, value creation, subject/patient access and other disciplines to support your Early Phase planning.
The unique Syneos Health collaboration model
Our strategic approach to Phase I research includes obtaining patient insights earlier in the clinical development process. We’ve developed three unique collaboration models that promote partnership with select investigators and their patients to motivate participation and engagement, while incorporating experienced staff and facilities for effective study oversight and execution.
Model 1: Partnership and Shared Tasks
- Certain components are conducted at the sub-investigator site, such as recruiting and screening, while others are conducted at our Phase I unit using our staff with the sub-investigator present.
Model 2: Divide and Conquer
- A portion of the study is conducted at our collaborator’s site and the balance at our Phase I unit in addition to any CRO services.
Model 3: Out-Patient Study Network
- Delivering site feasibility, selection and management, and investigator support for study conduct and any peripheral CRO services.
First-patient insights, faster
Our strategic approach to Phase I research includes obtaining patient insights earlier in the clinical development process . Our experience provides the services and solutions you need for your trial to succeed, whatever the therapy area. Learn more about our early phase oncology expertise and how it supports our commitment to getting new cancer therapies to patients.
Global reach, customized to your needs
Whatever the size of your organization and wherever you are in the world, our global reach combined with our collaborative approach to partnership offers you full-scale support delivered as a boutique service.
- Our global footprint includes units in Miami (USA), Quebec City (Canada), Princeton (USA), Sophia-Antipolis (FRA) and throughout a network of external units the European and Asia-Pacific region.
- Our combined facilities provide access to three different regulatory environments in four unique geographies - APAC, EU, Canada and US.
