Preclinical Icon

PRECLINICAL

The generation of a robust, focused and convincing preclinical data package is critical for regulatory and clinical development success. Failure to appropriately plan and execute a suitable preclinical development program is a common source of regulatory application failures and delays in the Cell and Gene Therapy Industry.

DHC can provide deep, in-house subject matter expertise in Preclinical Development of cell and gene therapies, offering access to the expertise and tools needed to thoroughly evaluate the safety and efficacy of innovative potential therapies to enable regulatory success and the subsequent initiation of clinical evaluation.

Our team offers extensive technical subject matter expertise to assist you in successfully navigating this complex path. Our most popular services include:

Preclinical Strategy Planning: We help you to define and describe your preclinical development plan and preclinical safety and efficacy endpoints to optimally support your regulatory and clinical strategies.

De novo Preclinical package design: We work with you to understand your intended clinical population and setting, and carefully develop a Preclinical package in a relevant model with meaningful safety and efficacy endpoints.

Vendor selection: We work with you to understand your development strategy, pipeline asset, agency interaction timelines, geographical considerations and operating budget, to identify, appraise, audit and recommend the most appropriate vendor(s) to successfully achieve your objectives.

Oversight of Preclinical Study Execution: Our in-house expertise can be deployed to oversee (remotely or in person) the execution of Preclinical studies, and analyze the generated data.

Preclinical Data Compilation and Review: We assess your pipeline asset and compile data from your lab notebooks and study reports into a comprehensive tracking-and-trending database. We evaluate this data using statistical analysis software to help you to understand your preclinical data and its trends in a way that you might not have done previously

Preclinical Package Gap Analysis and Study Design: We review your existing preclinical data package for completeness and suitability, and carefully develop a comprehensive preclinical roadmap to make your data package more robust, complete and likely to succeed in gaining regulatory agency approval

Technical Writing: We either write your Preclinical section of your regulatory submission package in CTD format, or review the package that you have prepared, ensuring that essential items are thoroughly and appropriately addressed and clearly communicated.

Post injury recovery
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Preclinical

The generation of a robust, focused and convincing preclinical data package is critical for regulatory and clinical development success. Failure to appropriately plan and execute a suitable preclinical development program is a common source of regulatory application failures and delays in the Cell and Gene Therapy Industry.

DHC can provide deep, in-house subject matter expertise in Preclinical Development of cell and gene therapies, offering access to the expertise and tools needed to thoroughly evaluate the safety and efficacy of innovative potential therapies to enable regulatory success and the subsequent initiation of clinical evaluation.

Our team offers extensive technical subject matter expertise to assist you in successfully navigating this complex path. Our most popular services include:

Preclinical Strategy Planning: We help you to define and describe your preclinical development plan and preclinical safety and efficacy endpoints to optimally support your regulatory and clinical strategies.

De novo Preclinical package design: We work with you to understand your intended clinical population and setting, and carefully develop a Preclinical package in a relevant model with meaningful safety and efficacy endpoints.

Vendor selection: We work with you to understand your development strategy, pipeline asset, agency interaction timelines, geographical considerations and operating budget, to identify, appraise, audit and recommend the most appropriate vendor(s) to successfully achieve your objectives.

Oversight of Preclinical Study Execution: Our in-house expertise can be deployed to oversee (remotely or in person) the execution of Preclinical studies, and analyze the generated data.

Preclinical Data Compilation and Review: We assess your pipeline asset and compile data from your lab notebooks and study reports into a comprehensive tracking-and-trending database. We evaluate this data using statistical analysis software to help you to understand your preclinical data and its trends in a way that you might not have done previously

Preclinical Package Gap Analysis and Study Design: We review your existing preclinical data package for completeness and suitability, and carefully develop a comprehensive preclinical roadmap to make your data package more robust, complete and likely to succeed in gaining regulatory agency approval

Technical Writing: We either write your Preclinical section of your regulatory submission package in CTD format, or review the package that you have prepared, ensuring that essential items are thoroughly and appropriately addressed and clearly communicated.

Post injury recovery
slice
Preclinical

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