CDISC Standard for Exchange of Nonclinical Data (SEND): A Comprehensive Guide for Better Data Sharing and Compliance

The CDISC Standard for Exchange of Nonclinical Data (SEND) is a crucial framework in the pharmaceutical and biotechnology industries, ensuring that nonclinical study data is standardized, organized, and compliant with regulatory requirements. As global regulations around clinical trials become increasingly complex, the adoption of the SEND standard has become essential for companies seeking to submit nonclinical data to regulatory authorities like the FDA, EMA, and others.

At CliEvi, we specialize in assisting pharmaceutical companies, contract research organizations (CROs), and researchers in navigating the complexities of SEND data preparation, submission, and compliance. Our expertise ensures that your data meets regulatory standards, is efficiently managed, and is ready for seamless submission to regulatory agencies.

What is CDISC SEND?

The SEND (Standard for Exchange of Nonclinical Data) is a standardized format developed by the Clinical Data Interchange Standards Consortium (CDISC) for the submission of nonclinical study data. Nonclinical data refers to preclinical data collected during laboratory or animal studies that support the development of pharmaceuticals, biologics, and other medical products. These data are crucial for understanding the safety and efficacy of new treatments before human trials.

SEND aims to:

• Standardize nonclinical data across studies and research organizations.
• Facilitate regulatory submissions by ensuring that data is in a format recognized by regulatory bodies.
• Improve data consistency and comparability, enhancing the quality and transparency of the information submitted.
• Streamline the submission process, reducing errors and delays.

SEND is particularly important in the regulatory submission process. Regulatory authorities require that nonclinical study data be submitted in a standardized format, ensuring consistency and improving the review process.

Benefits of Using CDISC SEND

1. Compliance with Regulatory Standards

Regulatory authorities like the FDA and EMA require nonclinical data to be submitted in SEND format to ensure compliance with their guidelines. Using SEND ensures that your data submission meets these regulatory requirements and avoids potential delays or rejections due to non-compliance.

2. Improved Data Consistency

SEND provides a consistent, structured format for presenting nonclinical data, eliminating the inconsistencies that can arise when different research organizations or laboratories use their own formats. This consistency enhances the quality and clarity of the data and makes it easier for regulatory agencies to assess the safety and efficacy of new treatments.

3. Streamlined Data Submission Process

SEND simplifies the process of preparing and submitting nonclinical data. By using a standardized format, pharmaceutical companies and CROs can ensure that their data is ready for regulatory submission without the need for extensive reformatting or corrections. This reduces the time and resources required to prepare submission packages.

4. Enhanced Collaboration

The use of a common data standard fosters better collaboration among research teams, contract research organizations (CROs), and regulatory bodies. By adopting SEND, researchers and sponsors can ensure that their data is easily shared and understood by all stakeholders, including regulatory agencies, clinical trial teams, and data management professionals.

5. Improved Data Quality and Transparency

By adhering to SEND guidelines, data is presented in a way that reduces the risk of errors and inconsistencies. The standardization process also allows for better tracking and auditing of data, which improves transparency. This ultimately strengthens the credibility of the data and facilitates more accurate decision-making.

How CliEvi Can Assist with CDISC SEND

At CliEvi, we provide comprehensive services to support organizations in implementing the SEND standard for nonclinical data exchange. Our expert team ensures that your data is formatted, structured, and ready for submission to regulatory authorities. Here’s how we can help:

1. SEND Data Preparation and Formatting

Our experienced team helps in converting nonclinical data into the SEND format required by regulatory agencies. We follow the strict guidelines of CDISC SEND to ensure your data is accurate, consistent, and compliant. We work with your research teams to ensure that the data is appropriately structured and validated.

2. Data Validation and Quality Assurance

We offer comprehensive data validation services to ensure that your SEND data meets the highest quality standards. Our team conducts thorough checks to identify and correct any errors or inconsistencies in the data, ensuring that it complies with regulatory requirements and CDISC guidelines.

3. Regulatory Submission Support

Once your data is prepared and validated, CliEvi provides full submission support for regulatory agencies like the FDA and EMA. We assist in compiling and organizing all necessary documents, ensuring that the submission is complete and meets the requirements of the regulatory body. Our experts also provide guidance on any follow-up actions needed after the submission.

4. Training and Consultation

We offer training and consultation to help your team better understand CDISC SEND and its application in nonclinical data exchange. Our expert trainers will guide your team through the key principles of SEND, helping them gain the necessary skills to handle SEND submissions independently in the future.

5. Ongoing Support and Updates

The regulatory landscape and SEND standards are constantly evolving. CliEvi provides ongoing support to ensure that your submissions remain compliant with the latest guidelines and regulations. We stay updated with changes in SEND standards and regulatory requirements and assist you in implementing necessary updates to your data and processes.

Where Can SEND Data Be Published?

Once the nonclinical data is formatted and validated according to the SEND standard, it can be submitted to various regulatory agencies and, in some cases, published in scientific journals or presented in conferences. Regulatory authorities such as the FDA and EMA require SEND-format submissions for new drug approvals, biologic submissions, and other therapeutic interventions. Additionally, high-quality nonclinical studies may be published in prominent scientific journals focused on pharmacology, toxicology, and regulatory science.

Adopting the CDISC Standard for Exchange of Nonclinical Data (SEND) ensures that your nonclinical study data is consistent, compliant, and ready for submission to regulatory agencies. At CliEvi, we specialize in assisting pharmaceutical companies, CROs, and researchers in preparing, formatting, and validating SEND data for seamless regulatory submissions. By leveraging our expertise in SEND and regulatory compliance, you can streamline the data submission process, enhance data quality, and improve the chances of successful regulatory approval.

Contact CliEvi today to learn how our SEND services can support your nonclinical data submission process and help you meet the highest standards of regulatory compliance.