Navigating the SEND requirements can be complicated. By asking the right questions upfront, you'll be able to choose a knowledgeable and experienced partner who can guide you through the process, help you avoid potential delays and prepare reliable SEND datasets for FDA submissions.

Before you choose your SEND partner, read our frequently asked questions and quick pro tips.

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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.

Compliant and reliable datasets for your nonclinical study data are critical for successful FDA submissions. To ensure you are SEND-ready, our SEND team can help guide you through the requirements and the challenges. Altasciences uses submit^TM software to create datasets, and Pinnacle 21 to ensure data integrity.