第II相～第IV相
Offering a combination of experience, scale and agility and proactivity for all phases of clinical development
With no time to waste, conducting clinical trials in today’s complex and constantly evolving environment for R&D requires applying a combination of scientific, therapeutic and operational expertise – all at the right time.
At Syneos Health, we couple all this with the foresight gained from our extensive experience across the clinical to commercialization continuum -- helping you identify operational opportunities and risks as you strive to meet study milestones and deliver on your therapy’s promise to patients.
A data-informed approach for more predictable clinical trial delivery
Site Identification and Selection
We bring together our experts (feasibility, therapeutic and operations) with a data-driven, AI-powered approach to clinical trial site identification, feasibility and selection, developing a country and site strategy tailored for your study or program.
When delivering your study, we also build on the meaningful connections we’ve cultivated with sites. For example, our Catalyst Site Network is a select group of high-performing sites from across the globe, strategically and therapeutically aligned to your needs. Catalyst Network sites support faster clinical trial site activation and efficient delivery on a larger number of studies while providing a framework for development of enhanced methodologies that will promote further gains in clinical research and site sustainability.
Study Activation
Clinical trial start-up is one of the most complex and heavily regulated parts of any clinical trial or program launch, involving a significant number of stakeholders at start-up sites, regulatory agencies, ethics committees and vendors. Our team comprises 1,000+ employees dedicated to all aspects of clinical trial site start up services and regulatory operations, including Ethics Committee/Independent Review Board submissions, regulatory authority submissions, clinical trial site feasibility and contract negotiation and corresponding oversight.
Patient Recruitment, Enrollment and Retention
Slow enrollment has the biggest impact on meeting study timelines, which is why we focus on building strong, collaborative relationships with sites, and on understanding the disease and a patient’s potential path to enroll and remain in a study.
We leverage our cross-enterprise expertise – including patient specialists, behavioral psychologists and tech and data analysis – to generate insights about your protocol, patient populations and sites. This allows us to create the best fit-for-purpose solutions to clinical trial patient recruitment, overcome enrollment, retention and representation challenges and enable more predictable clinical trial delivery.
We also leverage sophisticated technologies and home health offerings that help reduce patient burden and improve the patient experience, thus facilitating retention and patient-centric data collection.
Bringing clinical trials closer to patients and communities
Our hybrid and decentralized solutions group brings together scientific and therapeutic expertise, behavioral understanding of sites and patients, and dynamic technology and capabilities to create customized solutions when your protocol – in whole or in part – calls for digital tools (e.g., wearables and sensors) and/or remote solutions, including in patients’ homes.
We identify opportunities for digital and hybrid approaches early in the planning process to effectively manage and mitigate executional complexities, drive efficiency, reduce cost and speed development.
Facilitating quality and consistency with enhanced business practices
Our commitment to high-quality delivery is further enhanced by advanced business practices. The Trusted Process®, our proven, proprietary methodology, has been modernized for today’s market realities – focused on you and your delivery goals.
Grounded in a culture of collaboration and accountability, our study teams put in place oversight to ensure we’re always looking around the corner to mitigate risks and delays. This results in the delivery of clean, reliable data to support rapid decision-making and regulatory submissions while ensuring consistent, on-time delivery.
Enhanced study visibility for better decision-making and performance
Because we understand our customers’ need for visibility to their data in near-real time to enable seamless operational oversight and efficient decision-making, we offer Synopsis™ Connect – a suite of detailed, centralized dashboards which provide comprehensive and centralized data visualizations that align with study-level projects. Our Synopsis platform provides visualization for study progress and performance, driving data quality and predictive risk detection.
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