From ad hoc consultancy on an hourly basis to long term commitments, we will assist you in making informed decisions about

  • SEND compliance
  • Data mapping and conversions
  • Terminology maintenance
  • Data Management Processes and SOPs
  • A nonclinical Data Managers role and responsibilities
  • Data standard implementation approach
  • Aligning nonclinical study conduct and data collection to a semi-automated, structured electronic data management
  • Data standards and terminology transitions between versions
  • Defining User Requirement Specification for IT solutions
  • Align data standardization strategy with regulatory expectations
  • Regulatory submissions and feedback responses
  • Defining submission formats for special endpoints

Contact us for specific data standards inquiries.


CDISC SEND training:

To request CDISC authorized SEND training, please visit and follow the instructions.

Upcoming SEND training:

List of public CDISC courses

  • New service: We offer training in SEND 3.1

- changes for general toxicity and carcinogenicity studies compared to SEND 3.0 and how to model safety pharmacology studies

  • New service: We offer training in SENDIG-DART 1.0

- how to model embryo fetal developmental studies

  • Client specific training on topics such as

Regulatory requirements to nonclinical electronic data

The content of a nonclinical submission package

Data responsibility and ownership

Data standardization approaches and considerations

Data validation - principles, process and outcomes

Contact us for more information or specific training requests.

We base our methodology on the philosophy that each client is unique. One-size-fits-all approaches will never help your business reach its full potential. We deliver custom solutions, tailored to you - your industry, your culture, your company challenges.
Regardless of your business (Pharma, CRO, IT development company) you are facing data standards implementation decisions. It is all about making informed decisions, ensuring that every decision is highlighted with pro and cons, are they future proof, can you easily adopt to the ever evolving data standards or is your data standard implementation a static snap shot of here and now. How flexible vs. static in the implementation approach is wise? Every decision comes with a consequence. Make sure you know it when making the decision and not regret the decision later when the consequence is haunting you.





Business partner services

We are proud to serve as your business partner and ensure your continuous compliance with regulatory requirements to electronic data.

Our business services include:

  • Test submission reviewability assessment  Can your data be sufficiently reviewed by an FDA reviewer and is it aligned with the final study report?
  • Data standard gap analysis and proposed solutions - How far are you from meeting the SEND standard for submission?
  • Data conversion service - Electronic formats of nonclinical data will be converted to SEND or SDTM for data warehousing needs or for regulatory submission (Legacy data conversion plan, Define file and nonclinical SDRG included)
  • QC check of electronic data - Data consistency check between SEND datasets and reported individual animal tables or raw data extracts

Contact us for more information or inquiries about other business needs.