In the complex world of nonclinical research, data must be accurate, structured, and submission-ready to meet the regulatory expectations of agencies like the FDA. With the increasing adoption of CDISC SEND (Standard for Exchange of Nonclinical Data), ensuring compliance has become more than a best practice – it’s a regulatory requirement. However, navigating SEND standards, submission requirements, and evolving guidelines can be overwhelming without expert guidance.
That’s where FDA SEND consulting steps in. With specialized knowledge of SEND nonclinical data conversion, CDISC SEND services, and new labelling regulations, consultants play a crucial role in accelerating compliance, minimizing rework, and ensuring smooth regulatory approvals. This article breaks down everything you need to know about the value of SEND consulting and how it supports successful drug development and submissions.
Introduction to SEND and Its Regulatory Significance
What is SEND?
SEND, or Standard for Exchange of Nonclinical Data, is a data standard developed by CDISC (Clinical Data Interchange Standards Consortium). It provides a consistent framework for organizing and formatting nonclinical study data, particularly from toxicology and pharmacology studies.
SEND enables:
- Standardized data representation
- Machine-readability and traceability
- Improved data quality and comparability
- Faster and more efficient regulatory reviews
SEND is primarily used for the submission of nonclinical study data to regulatory authorities, with the FDA mandating its use for most IND, NDA, and BLA applications.
The Role of CDISC SEND in FDA Submissions
Since 2016, the FDA has mandated the use of SEND for nonclinical studies in submissions. The CDISC SEND format is now a critical part of the regulatory package, just like eCTD or CDASH for clinical data. Submitting data outside this format leads to rejections, holds, or costly delays.
SEND standardizes:
- Study designs (e.g., SENDIG v3.1.1)
- Variables and domains (e.g., TS, EX, LB, etc.)
- Controlled terminology
- Metadata for traceability
This standardization streamlines FDA’s ability to review data efficiently and make faster decisions, which is why compliance is non-negotiable.
Evolution of SEND Requirements in Regulatory Frameworks
Over time, the SEND format has evolved to cover more types of studies and accommodate complex designs. Regulatory frameworks now extend SEND requirements to:
- General toxicology studies
- Carcinogenicity studies
- Safety pharmacology
- Reproductive and developmental toxicity (DART)
Additionally, new labelling regulations now require enhanced traceability between nonclinical evidence and product safety profiles, adding more pressure on accurate SEND submissions.
The FDA’s Study Data Technical Conformance Guide is frequently updated, meaning companies must stay current or risk compliance gaps.
Understanding FDA Expectations for SEND Compliance
FDA’s Data Standards Catalog
The FDA Data Standards Catalog outlines the data formats and standards acceptable for regulatory submissions. For SEND, it specifies:
- Supported SENDIG versions (e.g., 3.0, 3.1.1, 3.1.2)
- Applicable study types
- Required controlled terminologies
Failure to align your submission with the latest catalog leads to Technical Rejection Criteria (TRC) flags, stopping the review process until corrections are made.
Submission Requirements for Nonclinical Data
As of today, most general toxicology studies included in INDs or NDAs must be submitted in SEND format if:
- Conducted after December 2016
- Part of pivotal or supporting safety data
- Conducted under GLP (Good Laboratory Practice)
Each SEND package must include:
- SEND datasets (.xpt format)
- Define.xml (data definition file)
- Study data reviewers guide (SDRG)
- Annotated study protocols or templates
SEND files are integrated into the eCTD structure, under Module 4 (Nonclinical Study Reports).
Common Reasons for SEND Rejections and Delays
Even with available resources, many submissions still get flagged due to:
- Invalid or outdated SEND versions
- Incomplete or inconsistent domain data
- Improper controlled terminology usage
- Errors in Define.xml or SDRG files
- Poor mapping of legacy study data
These issues not only cause rework but also impact submission timelines and regulatory confidence.
Why FDA SEND Consulting is Critical
Role of SEND Consultants in Regulatory Strategy
FDA SEND consultants bridge the gap between technical SEND requirements and real-world study data. Their role goes far beyond formatting:
- They guide early study planning with SEND in mind
- Perform gap assessments on legacy datasets
- Assist in data mapping and controlled terminology alignment
- Oversee dataset generation, validation, and final packaging
Their expertise ensures SEND implementation is proactive, not reactive – saving both time and resources.
Early Engagement for SEND Planning and Study Design
One of the biggest mistakes sponsors make is waiting until the end of a study to think about SEND. But SEND should be integrated at the protocol development phase. Consultants help:
- Design SEND-compliant protocols and data capture forms
- Coordinate with CROs to align study data structures
- Define controlled terms and metadata before data collection starts
This foresight prevents the need for tedious data transformation later.
Bridging Gaps Between Sponsors, CROs, and Regulatory Teams
Many sponsors work with multiple CROs, each with their own processes. FDA SEND consultants act as central coordinators, aligning everyone involved:
- Harmonizing data from different CROs
- Ensuring consistent SEND datasets across submissions
- Communicating regulatory expectations to non-technical teams
This alignment boosts submission quality and eliminates costly inconsistencies.
The Power of CDISC SEND Services
What CDISC SEND Services Include
Comprehensive CDISC SEND services span the full lifecycle of a nonclinical submission, including:
- Study planning and SEND readiness assessments
- Data mapping and domain creation
- SEND dataset generation and validation
- Define.xml and SDRG authoring
- Compliance testing and final SEND package assembly
Experienced service providers also offer SEND-specific project management, regulatory support, and integration with eCTD submissions.
Ensuring Standardization, Traceability, and Quality
The purpose of SEND is not just formatting – it’s standardization and traceability. A good SEND services partner ensures:
- Consistent data capture aligned with CDISC controlled terminology
- Full traceability from raw data to SEND datasets to final report
- Proper documentation that supports audits and inspections
This is critical not just for the FDA, but increasingly for global agencies like PMDA and Health Canada.
Importance of SEND Dataset Validation Tools
Before submission, every SEND dataset must pass rigorous validation using tools like:
- Pinnacle 21 Validator (FDA’s preferred tool)
- SENDIG compliance checkers
- Custom rule sets for internal QA
SEND consulting partners run these validations, interpret the results, and resolve issues – ensuring a “clean” submission that meets all FDA expectations.
SEND Nonclinical Data Conversion: Key Challenges and Solutions
Data Mapping and Transformation Complexities
One of the most complex aspects of SEND nonclinical data conversion is accurate data mapping. Study data is often captured in formats not designed for SEND, including Excel files, SAS datasets, or proprietary systems.
Challenges include:
- Misalignment between source data and SEND domains
- Missing or inconsistent metadata
- Inadequate understanding of controlled terminology
- Variability in how CROs structure datasets
SEND consultants tackle these issues by:
- Performing detailed data audits
- Creating data transformation specifications
- Working alongside programmers and data managers
- Validating transformations to ensure integrity and traceability
A well-executed mapping process ensures that each piece of data ends up in the correct domain, with the right format and context – making it reviewable and reliable.
Handling Legacy and Hybrid Study Data
Many sponsors have years of preclinical data that predates SEND requirements. These legacy studies are often critical for submissions, but converting them is a challenge.
Key issues include:
- Missing data fields required in SEND
- Incomplete historical records
- Manual entry or scanned documents
FDA SEND consulting provides strategies to handle this:
- Gap analysis and feasibility assessment
- Hybrid SEND mapping combining old and new standards
- Data imputation or flagging of missing variables
- Justification documentation in SDRG
By bridging legacy and modern data formats, consultants ensure older studies can still support new regulatory applications.
Tools, Workflows, and Automation in SEND Conversion
SEND conversion isn’t just about manual effort. Tools and automation now play a big role in speeding up and improving the quality of conversion projects. Common tools include:
- SENDIG-based SAS macros
- Automation platforms for data import/export
- AI tools for metadata extraction and validation
- Version control tools for dataset lifecycle tracking
Experienced SEND service providers use these tools to create efficient workflows, reduce manual errors, and deliver scalable solutions – even across large datasets and multiple studies.
Aligning SEND with New Labelling Regulations
SEND data isn’t just for FDA reviewers – it also feeds into the larger regulatory narrative, including safety labeling, risk assessment, and pharmacovigilance.
New global and regional labelling regulations now require:
- Stronger evidence for safety claims
- Clear traceability of adverse events
- Data-backed justification for warnings, precautions, and contraindications
SEND datasets provide structured, auditable evidence to support this:
- LB domain for lab findings
- CL domain for clinical observations
- RE domain for reproductive data
By working with a SEND consultant, sponsors can ensure their datasets are not only compliant but also support accurate and defensible labelling – minimizing legal and compliance risks.
Benefits of Outsourcing FDA SEND Consulting
Faster Submissions with Fewer Errors
A consultant brings in structured workflows, validated tools, and pre-built templates that streamline submission readiness. You avoid trial and error, reducing cycle time and speeding up your time to market.
Improved Regulatory Relationships
When your SEND data is clean, traceable, and compliant, it makes life easier for FDA reviewers. This builds trust, shortens review timelines, and reduces the number of queries or rejections.
Cost Savings and Scalability
Instead of building internal SEND capabilities from scratch, outsourcing lets you scale on demand – whether you need help for one study or 20. You only pay for the expertise when you need it, without the overhead of full-time staff.
Why Choose MakroCare for FDA SEND Consulting?
At MakroCare, we offer full-spectrum CDISC SEND services designed to meet FDA and global regulatory expectations. Our consulting expertise includes:
- SEND readiness and strategy development
- Dataset generation and validation
- Legacy data conversion
- Regulatory submission support
We also support integration with broader regulatory services, including labeling, eCTD publishing, and clinical document preparation, giving you an end-to-end solution under one roof. With MakroCare, your SEND submission is in expert hands – from study start to regulatory success.
Conclusion
FDA SEND consulting isn’t just a service – it’s a strategic advantage. As SEND standards evolve and regulatory requirements become more stringent, having a team of SEND experts on your side ensures that your nonclinical data is accurate, compliant, and submission-ready.
From CDISC SEND services to SEND nonclinical data conversion, expert consultants help navigate the complexity, bridge data gaps, and accelerate compliance. They align your submission strategy with new labelling regulations, streamline your workflows, and reduce costly delays.
Whether you’re starting from scratch or updating legacy studies, partnering with an experienced SEND consultant like MakroCare is the key to faster, smoother, and more successful regulatory submissions.
FAQs
1. What is the main purpose of SEND in regulatory submissions?
SEND standardizes nonclinical data for regulatory review, allowing the FDA and other agencies to efficiently analyze toxicology and pharmacology studies submitted with INDs, NDAs, and BLAs.
2. When is SEND required by the FDA?
SEND is mandatory for most nonclinical studies submitted after December 17, 2016. The requirement applies to general toxicology, safety pharmacology, and carcinogenicity studies in IND, NDA, and BLA submissions.
3. How does FDA SEND consulting help sponsors?
SEND consultants offer guidance on data formatting, controlled terminology, dataset generation, and compliance validation. They reduce errors, align with evolving FDA expectations, and streamline submission timelines.
4. Can legacy nonclinical studies be converted to SEND format?
Yes, with expert guidance. SEND consultants use hybrid models, data mapping, and validation strategies to convert older data, ensuring it meets current SEND standards and is fit for submission.
5. What makes MakroCare a trusted SEND consulting partner?
MakroCare provides end-to-end CDISC SEND services, including planning, dataset creation, validation, and regulatory support. Their cross-functional team ensures high-quality, compliant submissions tailored to FDA and global requirements.
