Early Phase Services
Exploring new possibilities with scientific rigor and innovation
For more than 30 years, our specialized Early Phase team has been dedicated to meeting the unique challenges of this phase of research. We work with agility and flexibility, aiming to deliver customized solutions and actionable data to inform your strategic decision-making.
>250 Phase 1 Studies Conducted in the past 5 years
Delivering the highest-quality studies capable of taking your science to the next level
Our team is 100% dedicated to early phase clinical research. We’re able to conduct a variety of Phase I to Phase IIa studies (or a combination), including first-in-human (FIH), proof-of-concept, bioavailability/bioequivalence (BA/BE), drug-drug interaction (DDI), organ impairment, and thorough QT (TQT), biosimilar, and numerous pharmacokinetic (PK), single ascending dose/multiple ascending dose (SAD/MAD) studies.
Meeting today’s realities with new early phase clinical study designs and methods
We’re dedicated to exploring innovative approaches and new methodologies in early phase research, especially today when the field is evolving rapidly in response to time and cost pressures.
This includes Phase I/IIa combination clinical trials, which can deliver earlier insights into a drug’s safety and efficacy profile.
Access to the right sites with the right healthy participant/patient populations
Our global footprint includes state-of-the-art clinical research units in Quebec City (Canada) and Miami (USA). These units are staffed by more than 800 scientific and medical experts including experienced on-site nurses, pharmacists, clinical research associates and biometricians.
These full-service locations are equipped to conduct complex, high-intensity studies with participant comfort and safety top of mind. They also have a wide range of enrollment capabilities for meeting the specific needs of your study.
We also maintain strategic collaborations with external research sites with access to both general and special patient populations in North America, Australia, New Zealand, the Asia-Pacific region, Europe and the UK.
Comprehensive Clinical Pharmacology and Bioanalysis services, offered in both early phase and across the full product lifecycle
Bioanalysis
A Top 5 provider of bioanalysis capabilities
With expertise in complex method development, the team has developed more than 1,200 validated assays, with approximately 200 new methods validated every year.
For any phase study, we offer the full spectrum of assay services (development, validation and analysis) for:
- Pharmacokinetics, immunogenicity and biomarker assays
- Flow cytometry and PCR (polymerase chain reaction) testing
- State-of-the-art instrumentation platforms for mass spectrometry and ligand binding
Clinical Pharmacology
Helping you navigate the regulatory process
With expertise in complex method development, the team has developed more than 1,200 validated assays, with approximately 200 new methods validated every year.
Our Clinical Pharmacology services are supported by a global team of more than 150 experienced team members in Australia, Canada, China, Europe, India, the US and Taiwan, providing 24/7 support.
Our full Clinical Pharmacology capabilities encompass medical writing and IRB, biostatistics, pharmacokinetics and pharmacometrics, data management and reporting.
The right combination of deep scientific, medical and therapeutic expertise to match your needs
Our Early Phase team is supported by the extensive resources of Syneos Health, augmenting our ability to take an evolved, multidisciplinary approach with the goal of delivering exceptional results while remaining flexible and agile. This includes:
- Global therapeutic and specialty expertise (including in rare disease, oncology and neuroscience) for insights to guide early phase study design and operations.
- Experts in product development strategy, value creation, patient access and other disciplines to support your clinical development planning.
Full-scale support delivered as a boutique service – for when there’s no time to waste
Whatever the size of your organization and wherever you are in the world, our global reach and our consultative approach means we can work as an extension of your team, providing tactical options customized to your asset’s early development.
Rapid response times are built into our processes. Multidisciplinary teams of scientific, medical and operational experts consult regularly on customer study designs and strategies and provide you with concrete, rapid initial feedback.
We're ready when you are.
An unwavering commitment to safe and ethical early phase research
Our first concern is participant welfare as we strive – in partnership with our customers – to advance the delivery of life-changing therapies.
In addition to being subject to multiple layers of external oversight, Syneos Health has its own robust internal controls and processes to address participant safety and well-being, including:
- A thorough informed consent process that clearly describes study requirements, risks and the need for participant transparency
- Rigorous medical screening to determine study eligibility
- Around-the-clock monitoring to promptly address potential adverse events
These activities are subject to Sponsor audit or Health Authority inspection.
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