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To stay ahead of the diverse and evolving needs of its global customer base, YPrime has announced the expansion of its eClinical consulting portfolio to include data standards, clinical analytics and electronic clinical outcome assessment (eCOA) sciences.
As part of YPrime’s strategy to build awareness about the importance of standards in clinical research and the opportunities biopharmaceutical sponsors must apply them to their advantage, Terek Peterson, an industry-recognized expert on data standards and statistical programming was named Vice President, Clinical Analytics and Data Strategies. Terek will lead the team of professionals focused on solving complex data issues and implementing CDISC data collection and submission standards for clients. Common assignments for data strategies include enterprise-level data governance plans, set-up of CDISC-compliant domains, and development of operating procedures and training programs. Clinical analytics projects typically involve statistical guidance for projects involving complex study design, randomization or material list concepts.
“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.”
YPrime’s Director of eCOA Sciences, Celeste Elash, will assume the role of practice leader for eCOA consulting. In this role, Celeste will lead efforts to provide consulting support in the areas of complex assessments, solution design and mode equivalence testing recommendations.
“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.