Certara offers timely and flexible CDISC SEND (Standard for Exchange of Nonclinical Data) dataset creation and quality review services to support regulatory submissions, including both FDA Investigational New Drug (IND) applications and New Drug Applications (NDAs). Our expert biostatistics programmers deliver submission-ready datasets and associated documentation, including QC of external SEND datasets, dataset production, validation, Pinnacle 21 report generation, and nonclinical Study Data Reviewer’s Guide (nSDRG) creation. We also provide legacy SEND conversion for older studies, ensuring compliance with evolving FDA requirements. With over 300 health authority submissions in five years, Certara brings unparalleled expertise to regulatory data preparation.
SENDデータセット作成支援サービス
SEND dataset creation and quality review for FDA IND submissions
Comprehensive SEND dataset services for regulatory success
Expertise in SEND compliance
Our team is proficient in CDISC SEND standards, ensuring your datasets meet FDA requirements seamlessly.
Flexible and scalable solutions
We offer customized timelines and scalable solutions, including support for legacy SEND conversion projects.
テクノロジーに基づくサービス
Our proprietary SEND Explorer software allows our statistical programmers and your teams to use the same datasets for internal scientific review and data visualization.
Commitment to quality
QC review of SEND datasets for all studies and review of third-party deliverables to ensure data integrity and submission quality.
Certara's expertise in SEND dataset services
外部SENDデータセットのQC
SENDデータセットの作成と検証
Pinnacle21レポートの作成とレビュー
非臨床試験データレビュアーズガイド（nSDRG）
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SEND define.xml
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サターラの専門家
Ragini Hari
Senior Director, Biostatistics
Ragini has 20+ years’ experience in the fields of statistical programming, biometrics and data management in the pharmaceutical industry. She’s led multiple complex submissions to the FDA, EMEA and PMDA, and has demonstrated expertise in CDISC and regulatory submissions throughout her career. Prior to joining Certara, she held various leaders...
専門家に相談する
Thomas Peppard, MS
Senior Director, Biostatistics
Tom brings 20+ years’ experience and expertise in Phase 1-3 pharmaceutical research. At Certara, he develops and executes SAPs, advises on clinical trial design and simulation, and consults on data-driven decision making for pharmaceutical and biotech clients globally. He’s proficient across a range of trial designs and analyses including bio...
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Ready to streamline your FDA IND submissions with Certara’s SEND dataset services? Our team of experts is here to ensure compliance, efficiency, and success in your regulatory journey. Reach out today to learn more about our flexible and innovative solutions.
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FAQs
What is CDISC SEND, and why is it required for FDA submissions?
CDISC SEND is a standardized format for nonclinical study data, required by the FDA for regulatory submissions to ensure consistency and clarity.
Can Certara handle legacy SEND conversions?
Yes, we specialize in converting legacy nonclinical data into SEND-compliant formats, ensuring compliance with current FDA submission guidelines.
What is SEND Explorer, and how does it benefit my organization?
SEND Explorer is Certara’s proprietary data visualization platform, enabling scientists to analyze nonclinical data and make critical decisions effectively
