SEND Advantage™ Services
Simplifying Submission-ready SEND Conversion Processes
Instem’s SEND Advantage offers a complete suite of services to ensure your nonclinical data meets Standard for Exchange of Nonclinical Data (SEND) submission requirements. Whether you need SEND dataset creation, quality verification, compliance checks, or expert guidance, our team of industry-leading specialists, including active members of the Clinical Data Interchange Standards Consortium (CDISC), can help.
Get in touch today to learn more about how our team can help you achieve seamless, stress-free FDA submissions.
What is SEND Advantage?
SEND Advantage is a comprehensive suite of services designed to support pharmaceutical sponsors and CROs in meeting FDA SEND submission requirements. With Instem’s expert guidance, organizations can streamline the conversion, validation, and review of SEND datasets, ensuring accuracy, compliance, and efficiency.
Preparing SEND-compliant datasets can be complex and time-consuming. SEND Advantage takes the burden off your team by offering end-to-end SEND dataset generation, quality assurance, and expert consulting. Whether you need to convert raw data, verify datasets from a CRO, or check compliance against CDISC and FDA validation rules, Instem’s team of SEND experts – including members who helped develop the SEND standard – ensures your submission is flawless.
With SEND Advantage, we handle your datasets, no matter the complexity, so you can focus on what matters most – bringing safe and effective drugs to market faster.
Key Benefits of SEND Advantage
Ensure Compliance with Confidence
Our experts validate your datasets against FDA and CDISC SEND requirements, ensuring submission readiness for any dataset, no matter the complexity.
Improve Data Quality
We perform in-depth verification checks to ensure datasets are complete, accurate, and optimized for FDA review.
Access Unmatched Expertise
As key contributors to writing and maintaining the SEND standard, Instem provides the most knowledgeable SEND specialists in the industry, so you can outsource to us with confidence.
Save Time and Resources
Avoid the complexities of SEND formatting and compliance by outsourcing to the industry’s leading provider, freeing up your time and resources to focus on critical tasks.
Flexible and Scalable Solutions
Whether you need a one-time dataset conversion, training, or ongoing SEND support, we have a broad range of services that can be tailored to your specific needs.
Core Services
The SEND team at Instem offers a variety of services designed with expertise, quality, and speed in mind, giving you confidence in your submissions whether produced, reviewed, or fully outsourced by Instem.
SEND Deliver
We convert your nonclinical study data into SEND format, ensuring it meets all regulatory requirements. Ideal for organizations that lack in-house SEND expertise, need rapid conversion for complex studies, or simply need an extra pair of hands during busy periods.
SEND Comply
Verification Checks – A senior SEND expert performs a deep-dive review of dataset quality, identifying any potential issues before submission.
Conformance Checks – A high-level check to ensure studies hold together and will be reviewable by the FDA reviewer.
SEND Advise
Bespoke consultancy and training services to help organizations optimize their SEND processes. Whether your team needs expert guidance on SEND implementation, dataset review, or workflow improvements, our specialists provide hands-on support.
SEND Source
Augment your team with an Instem SEND specialist who can provide in-house expertise on demand. This flexible resourcing option helps teams fill skills, expertise, and capacity gaps in SEND capabilities.
SEND Warehouse
Convert large volumes of legacy nonclinical data (e.g., historical animal study reports) into digital SEND-compliant formats to populate a data warehouse, unlocking value and scientific insights from legacy data.
Why Choose SEND Advantage?
Instem is the global leader in SEND services, with more experience and completed studies than any other independent vendor. As key contributors to the SEND standard, our experts ensure the highest quality datasets with fast turnaround times and cost-effective solutions.
- Largest SEND provider worldwide – Trusted by top pharmaceutical companies and CROs.
- Unmatched expertise – Instem has more than 10 SEND specialists actively involved in CDISC standard development.
- Comprehensive service offering – From dataset conversion to compliance verification, we handle every aspect of SEND.
- Guaranteed accuracy and timely delivery – Our rigorous quality checks ensure seamless, efficient FDA submission in short turnaround times, no matter the complexity of your dataset.
With Instem’s SEND Advantage, you gain peace of mind knowing all your SEND needs are in the capable hands of our industry-leading experts.
How It Works
SEND Advantage streamlines your SEND submission process with a suite of expert-led services, ensuring compliance, accuracy, and efficiency.
SEND Dataset Creation
Convert your nonclinical study data into SEND-compliant formats with SEND Deliver, ensuring regulatory readiness.
Quality and Compliance Checks
Validate datasets through SEND Comply, with expert-led verification and conformance reviews to identify and resolve issues before submission.
Expert Guidance & Training
Optimize your SEND workflows with SEND Advise, offering tailored consulting and hands-on training.
Flexible Resourcing and Data Management
Augment your team with SEND Source specialists or convert legacy data into digital SEND-compliant formats with SEND Warehouse.
Frequently Asked Questions
The SEND team at Instem prioritizes educating our clients on the SEND standard to empower them to be faster and more standardized in their data management. How do we do that and what does it look like for you? Check our the FAQ section below for more information, and contact us if you have more questions.
How does SEND Advantage help with SEND compliance?
SEND Advantage provides end-to-end services, including dataset creation, validation, compliance checks, expert consulting, and legacy data conversion. Our team ensures your submission meets all FDA and CDISC SEND requirements.
What happens if errors are found in a dataset?
If we identify issues, we can provide detailed reports and recommendations for correction. We can also assist with dataset modifications to ensure compliance.
Can I get on-demand SEND expertise for my team?
Yes, SEND Source allows you to augment your team with experienced Instem SEND specialists on a flexible basis. Additionally, SEND Advise provides customized training and consulting to help your team improve its SEND processes and expertise.
Who needs to submit SEND datasets?
SEND is a regulatory standard mandated by the FDA for the submission of data resulting from many nonclinical study setups, with more study types being added all the time. It ensures consistency, facilitates review, and enhances data accessibility for regulatory agencies. Therefore, all pharmaceutical sponsors and CROs submitting nonclinical study data to the FDA must comply with SEND requirements for studies covered under the mandate.
Get a Free Demo Today
Ensuring FDA compliance doesn’t have to be complicated. With SEND Advantage, you get expert-led dataset creation, validation, and consulting services tailored to your needs.
Get in touch today and let our expert team handle the complexities – so you can focus on bringing safe and effective therapies to market faster.