In our first post, we explained why SEND (Standard for Exchange of Nonclinical Data) is no longer optional in regulatory submissions. Agencies like the FDA and PMDA now mandate SEND datasets to ensure that nonclinical study data is standardized, traceable, and scientifically meaningful.
Now it’s time to take the next step in understanding how to set yourself up for SEND success before your study even begins.
Too often, SEND is treated as a task to “take care of at the end.” But SEND isn’t just a set of files it’s the framework regulators use to connect subjects, observations, and conclusions. When multiple parties, sponsors, CROs, subcontractors, and vendors are involved, the only way to avoid delays and compliance risks is to plan early and align responsibilities upfront.
Why Early SEND Planning Is Critical
Delaying SEND until study completion often leads to submission risks:
- Missing or incomplete data that cannot be recreated
- Trial design domains (TE, TA, TX, TS) that don’t align with the protocol
- Define.xml files that fail to link properly
- Reviewer’s Guides (nSDRG) missing essential context
- Validation errors that delay regulatory review
With multiple stakeholders, the chances of misalignment multiply. Early SEND planning ensures consistency across datasets, reduces risk, and helps regulators evaluate your study faster.
For deeper insights, see our post on Mastering CDISC SEND Submissions.
Who Builds SEND (and Why Early Role Definition Matters)
The way SEND responsibilities are divided depends on study setup and outsourcing models:
1. Sponsor and CRO – CRO creates the full package
The CRO delivers datasets, define.xml, and the nSDRG. However, the sponsor must align on standards, conventions, and terminology to avoid inconsistencies.
2. Sponsor and CRO – Shared dataset creation
In some studies, the CRO builds most datasets, while the sponsor generates specific ones (e.g., pathology, PK, or lab). Both must agree on how these files will be merged.
3. Sponsor, CRO, and subcontractor
A subcontractor may provide datasets (e.g., bioanalytical or lab work), while the CRO assembles the package. Clear ownership of metadata and reviewer’s guide content is critical.
4. Third-party assembler
Specialized vendors can add efficiency but require early agreements on data formats, delivery timelines, and integration methods.
Regardless of the model, the principle is clear: define roles and responsibilities at the start to prevent SEND becoming a last-minute puzzle.
Key Questions to Ask at the Start
When setting up SEND expectations, three areas deserve careful planning:
1. Capabilities
- Which SENDIG, Define-XML, and Controlled Terminology versions can each partner support?
- Do they have experience or sample SEND datasets?
- Which data sources (toxicology, pathology, PK, telemetry) will each partner deliver?
2. Process
- Who owns define.xml and the nSDRG?
- Will interim SEND builds be shared or only final datasets?
- How will multiple datasets from CROs or subcontractors be merged?
3. Quality & Consistency
- How will SEND datasets be cross-checked with study reports?
- What processes ensure consistent controlled terminology across domains?
- How will validation outputs be reviewed for both technical compliance and scientific accuracy?
Common Pitfalls in SEND Submissions
Even experienced teams run into issues when SEND is not planned early:
- Incompatible datasets from multiple vendors
- Inconsistent terminology across domains
- Incomplete or inaccurate reviewer’s guides (nSDRG)
- Over-reliance on vendors without sponsor oversight
- Validation errors delaying submission timelines
Avoiding these pitfalls requires early planning and ongoing quality checks.
Best Practices for SEND Success
Leading sponsors and CROs follow these best practices:
- Start SEND planning during protocol development – Ensure trial design domains match the protocol.
- Document roles and responsibilities – Assign SEND ownership early.
- Use interim SEND builds – Validate data progressively, not just at the end.
- Agree on controlled terminology upfront – Prevent domain mismatches.
- Cross-functional QC – Involve toxicologists, statisticians, and regulatory experts.
- Leverage automation tools – Speed up dataset validation and reduce human errors.
For related regulatory considerations, see our post on Regulatory Compliance in Drug Development.
The Payoff of Early Alignment
When planned properly, SEND transforms from a compliance burden into a submission advantage. Benefits include:
- Structured, traceable subject-level data
- Faster FDA and EMA reviews
- Reduced regulator queries
- Cost savings through fewer revisions
- Greater credibility and regulatory trust
If your study involves toxicology datasets, pairing SEND planning with a robust Toxicology Risk Assessment ensures both compliance and scientific accuracy.
Final Thoughts
Planning for SEND from day one is not about extra work—it’s about building efficiency, transparency, and confidence into your submissions.
By defining roles, aligning standards, and performing quality checks early, you avoid last-minute surprises and deliver SEND packages that reflect both your study and your science.
Early SEND planning is the difference between regulatory risk and regulatory confidence.
FAQs on SEND Planning
1. What is SEND in regulatory submissions?
SEND (Standard for Exchange of Nonclinical Data) is a CDISC standard required by regulators like the FDA to structure nonclinical data for review.
2. Why is SEND planning important from day one?
Planning early ensures datasets align with protocols, reduces errors, prevents missing data, and avoids costly rework during submission.
3. Who is responsible for creating SEND datasets?
Depending on the model, responsibilities may fall on the CRO, sponsor, subcontractors, or third-party assemblers. Clear role definition is critical.
4. What are the most common SEND submission challenges?
Incomplete datasets, inconsistent terminology, weak reviewer’s guides, and validation failures are common challenges when SEND is left too late.
5. How does early SEND planning benefit regulatory review?
It ensures structured, accurate data, reduces regulator queries, and speeds up FDA and EMA review timelines.
6. What should be included in a SEND Reviewer’s Guide (nSDRG)?
The nSDRG should provide study context, dataset explanations, and metadata ownership to guide reviewers effectively.
7. Can interim SEND builds help?
Yes, interim builds allow early validation, help identify errors sooner, and reduce the risk of last-minute submission issues.
8. How can sponsors ensure SEND quality across vendors?
By aligning terminology, validating datasets against study reports, and conducting multi-step QC with both technical and scientific reviews.