Expanded eClinical Consulting Portfolio Helps Sponsors Prepare for Data Standardization and Modern Clinical Trials
MALVERN, P.A., October 15, 2019 –To address the evolving needs of its global customer base, YPrime announced the expansion of its clinical trial consulting services to include data standards, clinical analytics, and electronic Clinical Outcome Assessment (eCOA) sciences. This expansion strengthens YPrime’s ability to support sponsors navigating increasing regulatory expectations, data complexity, and modernization initiatives across clinical research.
As part of YPrime’s broader strategy to increase awareness of the importance of data standards in clinical research, the expanded consulting portfolio helps biopharmaceutical sponsors apply industry standards more effectively across their clinical programs.
Common consulting engagements focused on clinical data strategy include:
- Enterprise-level data governance planning
- Setup of CDISC-compliant domains
- Development of standard operating procedures (SOPs)
- Creation of training programs to support standardized execution
These services are designed to reduce downstream data transformation effort while improving consistency, traceability, and regulatory readiness.
“The adoption of data standards across all eClinical systems is urgently needed for the modernization of clinical trials,” said Shawn Blackburn, Founder and CEO of YPrime. “Data submissions to the FDA require standardized formats. The logical next step involves data collection in a single format to eliminate the time and cost-intensive task of manual conversion and transformation. In addition, the European Medicines Agency is focusing intensely on fully transparent audit trails—which require common standards to track data across time and multiple sources. If sponsors are not preparing for this future now, they won’t be able to take advantage of emerging technologies coming down the road that offer transformative benefits to time, cost and data quality.”
“eCOA design and implementation is a rapidly emerging discipline, requiring a mix of health economics, operational know-how, regulatory and eClinical system expertise. There are many questions related to regulatory matters, and a host of design considerations specific to therapeutic areas that arise in every deployment. eCOA managers often require expert consultation on solution design to ensure implementation consistent with industry best practices and regulatory expectations,” said Mark Maietta, President of YPrime.
Through its expanded clinical trial consulting services, YPrime supports sponsors seeking to modernize trial execution, improve data quality, and prepare for evolving global regulatory requirements.
To learn more about YPrime Clinical Trial Consulting, visit www.yprime.com/consulting-services.