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Phase I-III Clinical Trials
Navigate clinical trial complexities with the help of Cytel’s data-driven strategies and optimized trial designs. We can help you accelerate your drug development, ensuring efficiency and successful outcomes.
Early Phase and Late Phase Solutions
Cytel’s comprehensive suite of solutions for clinical trials is designed to revolutionize every aspect of the drug development process. From pioneering complex and innovative trial designs to strategic clinical development planning, our expertise spans the entire drug development lifecycle. Harness the power of model-informed drug development and adaptive trial designs, supported by our cutting-edge software solutions.
Our integrated approach includes biometrics, regulatory strategy, medical communications, and data monitoring to ensure compliance and drive successful outcomes. We help you unlock market potential with tailored market access strategies that leverage real-world evidence and health economics to generate robust evidence and optimize patient access and outcomes.
Our Solutions
Regulatory Strategy
Many drug development projects fail due to constraints in time and funding. We can help you define your regulatory strategy early during development to ensure you do the right thing at the right time.
Data Strategy Planning for Success
Prioritizing data quality enables you to drive regulatory approval and make informed drug development decisions, allowing you to mitigate risks and maximize insights.
Data Monitoring Committees
Our vigilant oversight of trial data allows you to identify trends, anomalies, and potential issues, ensuring integrity throughout. Together with our Axio unit, our data monitoring committees deliver regulatory compliance and patient safety, fostering trust in your clinical trial outcomes.
Clinical Development Strategy and Planning
We can help you develop a successful clinical strategy with a systematic and forward-looking framework, encompassing key components from clinical hypothesis, clinical endpoints and measures (PK/PD, biomarker, PRO), to trial design, go/no-go milestone decision, patient population, and more.
Market Access Strategy
Do you have a strategy to unlock market potential? Our tailored approach ensures regulatory compliance and payer acceptance, enabling you to drive successful product launches and market penetration for improved patient access and outcomes.
Real-World Evidence (RWE)
Leverage our advanced quantitative techniques to generate robust evidence for regulatory and payer acceptance, support successful product development, and implement market access strategies globally.
Health Economic Outcomes Research (HEOR)
Take advantage of our innovative HEOR solutions to demonstrate your product value, inform market access strategies, and drive successful reimbursement submissions, to ensure optimal patient access and outcomes.
End-to-End Biometrics
Harness the power of biostatistics and statistical programming to optimize your trial design, data analysis, and reporting, and ensure robust results and regulatory compliance throughout your clinical development journey.
Software for Trial Design
Cytel's software platform empowers precise trial design and simulation, providing adaptive and Bayesian tools to optimize your study protocols and accelerate the drug development process with confidence and efficiency.
Complex and Innovative Trial Designs
Explore cutting-edge trial designs that leverage advanced analytics, AI, machine learning, and external control arms to optimize efficiency and outcome relevance, shaping the future of clinical research with innovation and adaptability.
Model-Informed Drug Development
Our Model-Informed Drug Development (MIDD) integrates quantitative models to optimize your decision-making in drug development, enhancing efficiency and success. We leverage access to diverse data sets to better inform your trial design, dose selection, and regulatory submissions.
Adaptive Trial Designs
Our adaptive clinical trial designs enable you to make protocol modifications based on accumulating data, offering efficiency, cost reduction, and flexibility over traditional designs. Each type has unique strengths and weaknesses, tailored to research questions and available resources.
100%
Acceptance of Study Designs by FDA
>6,000
Phase I-III projects in the last 10 years
45
NPS Score
Claim your free 30-minute strategy session
Book a free, no-obligation strategy session with a Cytel expert to get advice on how to improve your drug's probability of success and plot a clearer route to market.
