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How to prepare for SEND format requirements to ensure compliance for your preclinical studies and anticipate european developments.
In the rapidly evolving world of biotechnology, staying updated on regulatory requirements is essential for the success of your projects. Since 2023, the SEND (Standard for the Exchange of Nonclinical Data) format has become crucial for submitting nonclinical studies to the FDA. This article explains how SEND impacts the different phases of your trials and whether specialized tools like SAS platforms are necessary for compliance.
What is the SEND format and why is it important?
SEND is a standardized electronic format for submitting nonclinical study data. Introduced by the FDA, it is part of the broader CDISC (Clinical Data Interchange Standards Consortium) initiative, aimed at harmonizing how data is collected, organized, and submitted. The SEND format ensures that data is submitted consistently, facilitating review and analysis by regulatory agencies.
Which studies does the SEND format apply to?
- Preclinical studies: mandatory
This requirement includes toxicology, safety, and pharmacology studies submitted to the FDA for new drug applications (INDs, NDAs) or biologics license applications (BLAs). Since 2023, new types of studies (such as carcinogenicity and pharmacokinetics studies) must also comply with the SEND format according to the SENDIG 3.1 version. - Clinical trials: not required
The SEND format applies exclusively to nonclinical study data. However, similar CDISC standards, such as SDTM, are mandatory for clinical trial submissions, following similar harmonization principles.
EMA’s position: As of now, the EMA does not formally require the use of SEND. However, it is wise to prepare for this possibility as the global trend toward harmonization of regulatory standards is growing stronger. Early adoption of this format could provide a strategic advantage to companies that implement it before it becomes mandatory.
SEND: A technical constraint not to be underestimated
Many biotechs wonder if they can create SEND files internally or if they need to rely on external experts. While there is no obligation in this regard, this operation is often beyond the reach of a biotech, as generating compliant SEND files is complex and requires specialized expertise. Here’s why:
- Data complexity: Nonclinical data must be structured according to very precise models. Transforming raw data into SEND-compliant files requires advanced technical skills.
- Using SAS platforms: Most biotechs do not have the necessary in-house tools or software, such as SAS (Statistical Analysis System), to manage this transformation. These tools are essential for handling large datasets and formatting them correctly.
- Data management expertise: Even with tools like SAS, generating SEND files requires more than simple technical capabilities. A deep understanding of data structure and regulations is necessary to ensure compliance before submission.
A turnkey solution for your SEND format
At Oselys, we combine our expertise in biotechnology with our mastery of regulatory standards to provide you with a comprehensive solution to ensure SEND compliance. Our services include:
- SEND format generation: Using a dedicated SAS platform, we transform your nonclinical data into files that meet FDA requirements.
- Data audit and verification: We conduct thorough audits to ensure that all your data complies with the required standards before submission.
- End-to-end support: From study initiation to final submission, our team provides continuous support to ensure compliance with all regulatory requirements.
Why choose Oselys?
- SENDeExpertise: With our partners, we have already assisted numerous biotechs in achieving SEND compliance for their nonclinical studies.
- Flexible solutions: We understand that biotech budgets are often limited, which is why we offer phased payment models to ease financial management.
- Timely delivery: Regulatory submissions are often tied to critical deadlines. Our team is ready to act immediately to meet your timelines.
Contact us to schedule a free consultation with our experts and discover how we can assist you during this crucial phase.
Email: contact@oselys.com
KEY TAKEAWAYS:
- Le format SEND est-il obligatoire pour les études cliniques ? Non
Le format SEND est uniquement requis pour les études non cliniques soumises à la FDA. Les essais cliniques (phases I, II, III) doivent suivre d’autres standards CDISC, comme le SDTM. - Une biotech peut-elle implémenter le format SEND en interne ? Oui
Mais cela dépend des ressources humaines et matérielles dont elle dispose car la création de fichiers SEND nécessite une expertise en gestion des données et des outils spécialisés comme SAS. De ce fait la plupart des biotechs à font appel à des prestataires spécialisés. - L’EMA exige-t-elle le format SEND ? Non
À ce jour, l’EMA ne le demande pas. Toutefois, avec la tendance mondiale à l’harmonisation des standards, il est possible que l’EMA suive la FDA à l’avenir. Se préparer dès maintenant pourrait être avantageux.
