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Optimize Your Early Phase Clinical Trials with Cytel’s Innovative Designs and Expert Strategies
Discover how our Early Phase Solutions leverage cutting-edge trial designs and statistical expertise to streamline your drug development from initial concept to clinical reality.
Understanding the Potential of New Therapies
Early Phase Solutions encompass a critical segment of clinical drug development, covering the exploratory and confirmatory phases that typically include Phase I and Phase II, up to the initial part of Phase III trials (Phase IIIa). These phases are designed to evaluate the safety, tolerability, proper dosing and preliminary efficacy of new therapies. As you prepare to explore the full potential of a new product, you need a data-driven team known to reveal product value with swift delivery and precise execution.
At Cytel, our Early Phase Solutions are grounded in rigorous scientific methods and cutting-edge statistical expertise. Our integrated approach incorporates experts in data management, biostatistical programming, and medical writing who can identify product value quickly and precisely, giving your clinical trial the best chance to prove its value.
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Expertise in adaptive trial design
Particularly beneficial in early phase studies, this allows for more flexible and efficient trials by adapting your study to emerging results.
Statistical and computational excellence
Our robust team of statisticians and computational experts provide advanced analysis to drive your decision-making in early phase trials.
Global operational reach
We manage multi-site trials across different regulatory environments to provide you with smooth, streamlined international studies.
End-to-end biometrics services
From trial design, through execution, to final analysis and regulatory submission, we support every step of your early phase trial process.
Comprehensive Early Phase Clinical Solutions at Cytel
Cytel’s Early Phase Solutions are meticulously designed to guide your drug development from initial safety assessments to efficacy confirmation.
- In Phase I, we focus on assessing drug safety and dosage through rigorous statistical analysis, dose-escalation modeling, and simulation services to optimize your study design and dosing regimens.
- For Phase II, our team implements adaptive designs and conducts detailed statistical analysis to refine efficacy evaluations and optimize dosing strategies.
- Moving into Phase IIIa, our advanced biostatistical analyses support your regulatory submission processes, ensuring robust long-term efficacy and safety monitoring.
Our integrated approach enhances your trial efficiency, ensuring each phase builds strategically upon the last for seamless progression through clinical development stages.
Dose-Escalation Designs
Dose-escalation studies are a fundamental component of Phase I trials, where the primary goal is to identify the safest dose for use in later phases. These studies progressively increase the dose of the drug until a predetermined level of acceptable toxicity is reached, helping to establish the maximum tolerated dose (MTD). Including this in your content highlights a critical early-phase trial strategy. At Cytel, our clinical trial implementation teams are trained to work with a variety of dose-escalation designs, including both rule-based and model-based dose-escalation designs. These designs have been demonstrated to be superior to the classic “3+3” design and allow the identification of an optimal dose range for Phase II. Our expertise can help you refine dose levels more accurately, potentially reducing trial duration and improving patient safety.
Adaptive Trial Design eBook
Discover our eBook on Adapative Trial Design. This eBook speaks specifically to Phase I and Phase II challenges.
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Expertise in Innovative Trial Designs
Innovative trial designs, such as adaptive designs, play a pivotal role in enhancing the efficiency and effectiveness of clinical trials by allowing for modifications to the trial procedures based on interim data analysis. This is particularly important in early-phase trials, where data on drug behavior is still emerging. Cytel’s early phase teams have the advanced expertise to work with both Bayesian and Frequentist designs, initiate learning through small sample datasets, and make clinical data easily accessible to both your study team and your trial clinicians. In complicated therapeutic area applications such as oncology, modern designs such as Bayesian Optimal Interval (BOIN), Modified Toxicity Probability Interval (mTPI), i3+3, or Bayesian Logistic Regression Model (BLRM) based designs, allow a more flexible sample size, using small numbers of patients when there is little toxicity but allowing for more patients once toxicity is observed.
Learn moreAdditional Key Aspects to Consider
- Regulatory strategy and submission: We offer guidance on navigating regulatory requirements, including preparation for Investigational New Drug (IND) applications, and interactions with regulatory bodies such as the FDA or EMA. Find out more about our regulatory services.
- Data management and monitoring: We can provide you with robust data management systems and monitoring practices to ensure data integrity, compliance, and efficient handling of trial data. Find out more about our data management services.
- Safety monitoring: Our Data Monitoring Committees (DMC) or Safety Monitoring Boards (SMB) can oversee your trials, ensuring patient safety throughout the drug development process. Learn more.
- Bioinformatics and pharmacometrics: Our experts can leverage bioinformatics to analyze complex biological data and pharmacometrics for predicting drug behaviors, which can inform dosing and efficacy assessments.
- Model-informed drug development (MIDD): We use advanced modeling and simulation techniques to help you predict outcomes, optimize trial design, and reduce development time and costs. Find out more about our MIDD services.
10%
Of drugs that enter Phase I trials eventually gain FDA approval
20%
Proven shortening of trial duration by improved trial designs at Cytel
100%
Acceptance of our trial designs by regulatory agencies
35
Years of experience in adaptive trial design
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