Competitive Advantages Through Efficient Data Management

Data science offers solutions to help address real-world challenges making it the critical link between individual data streams and the integrity of the clinical research ecosystem.

Expanding volumes of data, multiple formats and a dependence on an increasing number of eClinical systems creates complexities with drug development as sponsors manage more data from diverse sources across a multitude of electronic information systems. A high-functioning clinical ecosystem drives better decision-making, operational efficiencies to reduce time and cost, and regulatory compliance to avoid costly errors and rework.

Data science creates competitive advantages through efficient management of data assets across the research and development value chain. YPrime’s professionals are key to linking multiple systems and implementing innovative technologies that increasingly pose demands on existing research infrastructure.

Blending traditional disciplines of clinical programming, data management, and biostatistics with deep knowledge of clinical research, our team of data science professionals help sponsors solve problems and make the most of their clinical trial data. Customers tap our expertise at various stages of the project lifecycle, from planning through execution to submission, with customized services and strategic consulting.

Data Standards

It’s not a question of “if” the use of data standards for data collection in clinical research will expand, it’s a question of when. Does the implementation of standards confuse you? That’s where we come in. Get a head start with YPrime. Our team has over a decade of experience implementing CDASH, SDTM, ADaM and Define-XML with submission experience in FDA and PMDA regulatory data standards.

Data standards are essential to drive efficient processes and high data quality across complex research processes. Without standards, it’s difficult—and in some cases, impossible—to connect data and systems for better context or effective study execution. A standards-driven approach enhances the value of data by making it easily stored, aggregated, and quickly retrieved for use and re-use – for decision support, regulatory support and reimbursement strategies, and good product stewardship – among many other uses. Tap into YPrime’s data standardization expertise to improve data quality and connect critical data across different streams.

 

eClinical Consulting

At YPrime, we pride ourselves on providing unparalleled professional services to our customers. Each of our eClinical consultants have a minimum of 10 years’ experience delivering trusted advice and expert support to our life science customers. Our clinical research expertise and deep technical knowledge provides customers with innovative solutions that assist them in meeting and exceeding their goals.

 

Data Monitoring

YPrime’s data science team helps ensure alignment with industry best practices and regulatory expectations. Protect against study risks by tapping into our expertise for assistance on your next eCOA or IRT study.

Effective clinical data integrity oversight requires sophisticated tools to dynamically manage compliance risks. YPrime’s data monitoring provides additional oversight of critical study data. This service combines automation and clinical expertise to ensure eCOA data collection compliance, data quality and integrity.

 

Statistical Consulting

Look to YPrime’s statistical expertise for guidance during study planning, at critical milestones, or as support for clinical study report activities. As an extension of your team, our experts can develop analysis plans, optimize trial design and randomization algorithms, independently review outsourced work, and provide statistical guidance for projects of all sizes and scope.

Contact us today to speak with one of our expert.

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