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  • Current: Clinical Development Programs

DEVELOPMENT PROGRAMS

Altasciences can provide a customized, end-to-end pathway for your drug development programs, from lead candidate selection through early-phase clinical trials. Our platform enables biotechnology and pharmaceutical companies to work with a single, integrated partner to develop molecules through to human proof-of-concept. Minimizing handoffs throughout the process results in faster timelines and reduced costs.

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Our teams of toxicologists, clinical pharmacologists, doctors, bioanalytical principal investigators, and technical staff have a knowledge base that spans a wide range of compounds, study types, therapeutic areas, and routes of administration. We welcome all questions regarding guidance and services you may require to move your compound through the many milestones of drug development.

Your Altasciences program manager will serve as a single point of contact for the entire life of your program, helping your test article advance from one milestone to the next and proactively sharing your preferences across all our operational groups. Our mantra is: Tell us once…

MOVING YOUR SMALL MOLECULE OR BIOLOGIC TOWARD REGULATORY APPROVAL

The process from lead molecule identification to approval can be long and complicated. Altasciences is here to help streamline and accelerate you through it.

The above is a general representation of drug development programs. We customize every development program to the molecule, mechanism, and indication. It is especially important to note that nonclinical and clinical studies required for the development of biologics can differ to an even greater extent.

INTEGRATED SERVICES

Preclinical

PRECLINICAL SERVICES

Our preclinical services include in vitro and in vivo studies that span lead optimization during discovery to non-clinical studies in rodent and non-rodent species that support drug development through Phase III. We provide a wide range of toxicology and laboratory services that meet global regulatory standards, and are experts at bridging safety assessments for entry into human trials.

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CLINICAL SERVICES

Our clinical services span from first-in-human studies to proof-of-concept to all the clinical pharmacology studies required before approval, including supporting studies such as driving simulation and QT assessments. Altasciences is a recognized leader in conducting first-in-human studies in both healthy normal volunteers and patient populations, with both small and large molecules.

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MANUFACTURING AND ANALYTICAL SERVICES

Integrated CDMO services and facilities to simplify and expedite your drug development programs. We have tested or manufactured virtually every dosage form available on the market, including powder- and liquid-filled capsules, nano-milled suspensions, gels, creams, tablets, powders, and terminally sterilized injectables. Expert pharmaceutical contract manufacturing teams can support your needs in commercial batches, validation, and controlled substances. We also offer analytical services such as development and validation of methodologies, and a range of product-release testing.

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BIOANALYSIS SERVICES

At any point in the process, from discovery through approval, you can rely on our Bioanalysis to move your development forward. Our comprehensive full-service model complements our preclinical, nonclinical and clinical offerings to best meet your needs.

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RESEARCH SUPPORT SERVICES

Comprehensive CRO services for preclinical and clinical studies, stand-alone or as part of a program, including regulatory guidance, protocol development, clinical monitoring, data management, medical writing, CDISC, SEND, archiving, and more.

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THERAPEUTIC AREAS

Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.

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