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Preclinical and Discovery Phase Services

Maximize your early-stage drug development with customized analytical methods to guide strategic decisions and accelerate discoveries for enhanced safety and efficacy.

Navigating Preclinical Development: Optimizing Strategies for First-in-Human Trials

The road from preclinical development to first-in-human clinical trials is all about doing the right things at the right time. The right strategy will enhance your chances of obtaining good results regarding efficacy and safety and reduce the risk of poor study results or a drug formulation that falls short of your claims. We empower you to optimize preclinical strategies by leveraging the power of data, technology, and analytics to streamline your planning processes and make informed decisions.

Whether you face complex protocols or pressing timelines, we offer tailored solutions to address your unique challenges, ensuring accelerated development and enhanced outcomes. With Cytel’s expertise and integrated approach, you can unlock the full potential of your portfolio and capitalize on opportunities for success in the ever-evolving landscape of drug development.

Our Solutions

Chemistry, Manufacturing and Controls (CMC)

How can you ensure that the medicinal drug is delivered to the right place in the body, in the right amount, at the right time, every time it is administered to a patient?

Our experts can assist in advising and planning the necessary formulation, process, and analytical development and reviewing formulation studies for successful CMC strategies.

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Model-Informed Drug Development (MIDD)

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.

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Toxicology Services for Safety and Risk Assessment

Our pre-clinical experts can help you compose an optimal study package, monitor your toxicity and safety pharmacology studies, and evaluate the results. We work with you, contributing to your regulatory documents and overall risk assessment throughout the development process, up to marketing approval and beyond.

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Clinical Pharmacology, Drug Metabolism, and Pharmacokinetics

We provide services to support your team in the discovery and development phases, both for non-clinical and clinical work. Our experts can take a strategic advisory role, or assist in planning, elaborating, and reviewing your clinical pharmacology and DMPK programs and studies.

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Evidence Strategy and Planning

Inform your strategic decision-making and maximize the value of your portfolio by developing comprehensive evidence strategies to integrate market access, biomarkers, and asset valuation.

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Data Strategy Planning for Success

We can help you prioritize your data quality to drive regulatory approval and informed drug development decisions, enabling you to mitigate risks and maximize insights.

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>30

Years of experience in Adaptive & Bayesian Trial Designs

100%

Regulatory acceptance of our data sets and trial designs

>700

Scientific publications in the past 10 years

Related Insights

The Road to First-in-Human Trials: Insights from a Real-World Example
Webinar
November 7, 2023
The Road to First-in-Human Trials: Insights from a Real-World Example
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Developing a New Drug Candidate: From Nonclinical to First-in-Human
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April 3, 2024
Developing a New Drug Candidate: From Nonclinical to First-in-Human
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Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials
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November 20, 2023
Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials
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Ulrika Andersson on First-in-Human Clinical Trial Development
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Industry Voices
November 6, 2023
Ulrika Andersson on First-in-Human Clinical Trial Development
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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.

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