Rely on YPrime to help your organization implement standards into current or new processes, evaluate new tools for data tabulation and analysis, or provide training to data management staff.
When YPrime is your partner for eCOA and IRT deployments, we can provide submission-ready deliverables as part of project delivery.
YPrime’s data standards experts have been developing and implementing standards for over a decade.
Our commitment to this area has ensured we not only keep current on the latest regulatory guidance, but also are actively involved with organizations that create industry standards. Our team members contribute to working groups at CDISC and PHUSE and engage in collaboration efforts across the industry.
Data standards not only create commonality and interoperability in processes from data collection to regulatory submission; regulatory agencies worldwide currently require and continue to expand their requirements for standardized data submission.
Data Standards Implementation and Hands-on Guidance
We can help customers implement data standards across their Research and Development infrastructure. This includes
- Development of enterprise-level data governance plans
- Set-up of programming environment and SDTM-compliant domains
- Development of operating procedures and training programs
For clinical programs and long-term projects, YPrime can interpret and recommend standards for eClinical systems. You decide which services you need to fulfill as part of your data standards implementation. We can be an extension of your team, or provide project-specific help when you need it.
Regulatory-ready Submission Deliverables
YPrime works with customers, both early on and strategically, to make CDISC developed standards an integral part of a clinical study’s eCOA and IRT deployment. We build in the standards and necessary tools to create an efficient workflow that accelerates data integration and ensures higher data quality. The use of near SDTM within data collection affectively implements SDTM as the operational standard across the full clinical trial process.
Our data standards experts constantly look for ways to remove the extra transfer steps and deliver data to the clinical and analysis teams faster. Our automated, streamlined process eliminates data re-entry, requiring fewer “touches” to reduce the risk of introducing errors. We can automate the creation of SDTM datasets, an advantage for sponsors seeking to reduce research time and cost.
Today, data standards play a significant role in the current trend of increased automation from protocol to collection. These efforts require the work of individuals who understand clinical trials, programming, data standards, and statistical reporting. YPrime’s data scientists and standards subject matter experts can successfully execute the requirements to support a successful submission. Not only do they understand standards, but also how FDA and PMDA reviewers use them within the review process.