From ad hoc consultancy on an hourly basis to long term commitments, we will assist you in making informed decisions about
Contact us for specific data standards inquiries.
CDISC SEND training:
To request CDISC authorized SEND training, please visit www.cdisc.org and follow the instructions.
Upcoming SEND training:
- changes for general toxicity and carcinogenicity studies compared to SEND 3.0 and how to model safety pharmacology studies
- how to model embryo fetal developmental studies
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:
Contact us for more information or inquiries about other business needs.