Our Solutions

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.

Consult our Integrated Offering Overview

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 of 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. All development programs need to be customized depending on the molecule, mechanism of action and indication. It is especially important to note that non-clinical and clinical studies required for the development of biologics can differ to an even greater extent. Please Let's Get Started to discuss what specific requirements your development program may need.

INTEGRATED SERVICES

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.

Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.

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WHY OUTSOURCE TO ONE PARTNER

Tell us once
Enjoy seamless integration of preclinical and clinical programs managed by ONE program manager.

Reduced timelines
Initiating clinical preparation during the preclinical stage can speed you from one drug development milestone to the next.

Integrated platforms/software
Our systems encompass preclinical and clinical development.

Access to experts
Our scientific and operational specialists deliver input into protocol design, interpretation of findings, and strategic options as you move ahead.

Personalized service
We continuously look for ways to provide value to you.

Quality
Our integrated quality team oversees all services and studies for consistency and thoroughness.

Bioanalytical support
Our Bioanalysis expertise and services encompass your preclinical and clinical needs.

We have your back
Your team at Altasciences believes in transparency, responsiveness, and the importance of being dependable.

Moving in unison, we are the CRO partner who is part of your team.

Working as a flexible, attentive extension of your team, we offer all you need to move your molecule forward.