Preclinical Study Management

AmplifyBio’s comprehensive study management services are designed to provide you with the support and expertise needed to bring your compounds from concept to clinical success. Partner with us to experience the benefits of a well-managed, high-quality preclinical study.

Comprehensive Study Management

At AmplifyBio, we are committed to providing meticulous study management to ensure the success of your preclinical studies, whether they are GLP or non-GLP. Our structured and collaborative approach ensures clear communication, efficient processes, and high-quality results. All of our Study Directors are experts in conducting GLP and non-GLP studies.

Pre-study Meeting with Key Personnel:

  • Introduction to key AmplifyBio team members.
  • Discussion of safety and potential areas of concern.
  • Alignment of team members to the goals and potential impact of your compound.
  • Enhancement of internal communication to ensure a seamless study process.

Post-Contract Engagement:

  • Study Director Assignment: Introduction of the Study Director who will oversee the study and serve as a primary point of contact.
  • Study Number Assignment: Each study is assigned a unique identifier for streamlined tracking and management.
  • Study Director Assignment: Introduction of the Study Director who will oversee the study and serve as a primary point of contact.
  • Project Manager Assignment:  Introduction of the industry experienced Project Manager who will assist in the full lifecycle of the client’s programs.
  • Protocol Development: Collaborative refinement of the project scope with you to ensure all study requirements are met.

Study Execution:

  • Continuous sharing of study progress and information with you.
  • Accessible primary points of contact (Study Director, Project Manager, Account Manager) throughout the study duration.

The AmplifyBio Difference

Our dedicated study management team is here to support you at every stage of your preclinical studies. From the initial engagement to the final report, we prioritize communication, quality, and efficiency to help you achieve your research goals.

  • Experienced Personnel: Our team is comprised of industry experts with extensive experience in managing complex studies.
  • Robust Processes: We follow rigorous protocols to ensure compliance and high-quality outcomes.
  • Client-Centric Approach: We work closely with you to understand your needs and deliver customized solutions.

AmplifyBio Preclinical CRO Services

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Preclinical CRO services play a crucial role in drug development by conducting studies and experiments on potential therapeutics before they advance to clinical trials. AmplifyBio offers a wide-range of preclinical CRO services including:

AmplifyBio Additional Services

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Comprehensive service programs for the development of Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial. Offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing available in an integrated, innovation-rich environment that goes beyond the value proposition offered by traditional CDMO and PDMO contract models.