Our Solutions

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?

 

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 support research services and bioanalytical expertise.

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

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