Research Support

  • Research Support
  • Integrating Anatomic and Clinical Pathology into reports

    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.

    Are you SEND-ready?

    You need SEND. We can help.

    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 submitTM software to create datasets, and Pinnacle 21 to ensure data integrity.

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    Partner With Confidence.

    • A seamless process. Our dedicated SEND team works onsite to ensure your data from collection to submission is accurately converted. With a single point of contact, your SEND expert will be accessible to answer your questions from start to finish.

    • Experience. As active members of the CDISC SEND Consortium and PhUSE (Pharmaceutical User Software Exchange) nonclinical working groups, our team contributes to the development of SEND standards and remains at the forefront of these evolving standards to support best practices.

    • Rapid turnaround. We understand the importance of your timelines and can prepare submission-ready files within two weeks. Interim datasets are also available for submission or for data warehousing purposes.

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    What can I expect to receive in my SEND package?

    • SAS Transport Files (XPT format)
    • Define file (XML format)
    • Study Data Reviewer's Guide [nSDRG] (DOC format)
    • Additional formats are available upon request

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    What do I need to know about recent and upcoming changes to SEND?

    • Effective March 15, 2019, SEND 3.1 is required for single- and repeat-dose general toxicology, Carcinogenicity studies and Safety Pharmacology studies for NDA, ANDA, and certain BLA submissions.

    • Effective March 15, 2020, SEND 3.1 is required for single- and repeat-dose general toxicology, Carcinogenicity studies and Safety Pharmacology studies for IND submissions.

    What is Altasciences doing to prepare for the future of SEND?

    The FDA Animal Rule and Standard for Exchange of Nonclinical Data (SEND)

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