EXPERTISE Matters.

With four strategically placed preclinical research facilities throughout North America, Altasciences can get your CTA/IND-enabling studies underway in just 8 weeks!

We offer a full range of in vivo non-GLP and GLP preclinical studies in both rodent and non-rodent species, to assess the safety of your small and large molecules in support of upcoming first-in-human clinical trials.

Our IND/NDA-enabling studies include:

      •   lead identification and optimization
      •   dose-range finding 
      •   pivotal toxicology (acute, sub-chronic, chronic, carcinogenicity)       •   pharmacology/safety pharmacology 
      •   bioanalysis

Time is of the essence―let’s get started!

Related resources that may interest you:

•   eBook: Nonclinical Safety Testing Guide 
•   Scientific Journal: IND Checklist for Your Preclinical Assessment
•   Webinar: Selecting the Right Species for Your Toxicology Program

Choose Excellence. Choose Success.

A well-designed formulation in preclinical studies ensures accurate dosing, stability, and safety of drug candidates, and provides essential data for regulatory submissions―contributing directly to the translational success of the drug compound from the preclinical to the clinical phase.

To successfully formulate your simple and complex APIs, our 64,000-sq.-ft., cGMP manufacturing facility in Philadelphia is equipped with cutting-edge equipment and processes that allow our scientists to provide:

      •   optimal drug solubility and bioavailability;
      •   dose accuracy and uniformity;
      •   PK/PD parameters;
      •   data on stability and shelf life; and
      •   optimal dosage form and route of administration.

Don't leave the formulation of your drug compound to chance.

Speak with one of our experts today to discuss your project, and let's bring your drug candidate one step closer to market.

Related resources that may interest you:

•   Webpage: Comprehensive Manufacturing and Analytical Testing Services
•   Scientific Journal: Critical Considerations in High Potency Manufacturing
•   Infographic: Choosing the Optimal Dosage Form for Your API

Best Practices for a Successful, Multi-Step Data Journey

In this issue of The Altascientist, we guide you through the complex, multi-step data journey for Phase I clinical trials, from study conceptualization and protocol development, to data collection and analysis, through to final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.

Speak with an expert to learn more about our service offering.

Have a few more minutes? Check out these insightful resources:

•   The Altascientist—CDISC Data Standards
•   Fact Sheet—Comprehensive Research Support
•   Blog—Data Management Excellence