The FDA requires that all new drugs be evaluated for adverse effects on the central nervous system during first-in-human (FIH) studies. If adverse effects are observed, such as somnolence, further clinical trials must be conducted with the addition of cognitive test batteries.

In collaboration with Cognitive Research Corporation (CRC), Altasciences designs and conducts specialized driving studies. Watch our experts explain in more detail.

Anatomic and Clinical Pathology datasets are critical when evaluating the safety and efficacy of a drug during the preclinical stage of drug development. Since anatomic and clinical pathology identify and characterize toxicity by different, yet complementary means, integrating both datasets provides a more comprehensive assessment for predicting important toxicities that could occur in humans.

Successful integration requires that anatomic and clinical pathologists collaborate closely. At least one of them must also understand the utility and limitations of both disciplines.

To ensure seamless integration of pathology data into the overall study report, our teams work closely with one another and follows established workflows and communication systems for every project. Additionally, our team can offer guidance on how to best use an integrated assessment for making critical decisions related to your drug candidate.

And, since one of our team members is a dual-certified Anatomic and Clinical Pathologist who brings over 25 years of drug development knowledge to Altasciences, you'll have a trusted partner available to guide you.

To learn more about how we can support you, speak to an expert.

Visit Our Preclinical Facility

Evaluating the safety and efficacy of your molecule requires partnering with a trusted Contract Research Organization (CRO). With over 25 years of experience conducting safety assessment studies in both large and small molecules, the Altasciences team has the expertise you need to provide high-quality safety data for your regulatory submissions.

Located just north of Seattle, our preclinical facility is convenient to travel to in order to conduct a capabilities overview or quality audit, or for study monitoring. With the recent opening of the Paine Field Airport, getting here has never been easier. The new airport services 9 destination cities and is less than 3 miles from our facility.

• Denver, Colorado
• Las Vegas, Nevada
• Los Angeles, California
• Orange County, California
• Phoenix, Arizona
• Portland, Oregon
• San Diego, California
• San Francisco, California
• San Jose, California

Schedule a visit, we would be happy to provide a tour.

Altasciences is a world leader in preclinical, clinical, and bioanalytical testing, and has been pioneering cannabis research for over 10 years in support of the FDA's strict guidelines on the use of the plant extract in medicinal products.

Sponsors partner with Altasciences in the early phases of their drug development program for our experience and innovative approach to evaluating the effects of cannabis on cognitive abilities.

Questions on cannabis studies, regulatory requirements, or how we can help with your early phase drug development program?

CONSULT WITH OUR EXPERTS