Customizing Clinical Metadata Repositories and Statistical Computing Environments

Clinical data is growing in volume and variability. It’s no secret that tracking and maintaining data standards, global forms and programming libraries is a complex undertaking. Trial sponsors without robust data management solutions risk inaccurate reporting and time-consuming analysis which could potentially affect patient outcomes and/or filing timelines. In addition, clinical trial managers are now being asked to deliver near real-time data visualization and data surveillance, nearly impossible without comprehensive end-to-end application of data standards, from protocol through to submission.

Especially challenging for predefined solutions, each organization has a unique set of legacy data, current systems, tool sets and technologies. A customized approach can address all these factors and improve metadata management to improve study builds and ease standards compliance. Customization best leverages each organization’s existing infrastructure investment and statistical programming use case requirements to accelerate data reporting while improving data standards governance.

• Implementation of a Statistical Computing Environment (SCE) yields the following benefits:
• Connection to any source data set
• Automated manual processes in clinical trials biostatistics and programming
• Ability to conduct regulatory and exploratory analytics in a single location
• Improved connections to data visualization tools to support surveillance 
• Reusability, process automation and end-to-end data traceability

Organizations can implement data standards and improve governance by maximizing the use and exchange of information via a clinical Metadata Repository (MDR). Benefits include:

• Reduced cost and condense development timelines
• Management of dissimilar clinical standards / incorporation of CDISC standards
• Harmonized document templates, SOPs, work instructions
• Scalable, near real-time data mapping and automated transformation
• Accelerated EDC builds, data transformations and statistical programming
• Improved trial visibility and management

Join expert speaker, Stephen Boccardo, in this live webinar to learn more about customized metadata management and statistical computing environment solutions for clinical trials.

Speaker

Stephen Boccardo, SVP Business Development and Commercial Strategy, Quartesian

As SVP Business Development and Commercial Strategy, Stephen Boccardo handles all aspects of customer business development including capability presentations, bid proposals and relationship management. Stephen combines more than 30 years of life science industry experience and dedicated technology expertise with a record of success on the clinical data management and systems side as well as growing startup organizations through sales and marketing leadership.

Mr. Boccardo joined Quartesian from Clinical Ink where he served as Chief Commercial Officer. In this role, he was responsible for all Clinical Ink global sales and marketing activities to drive market adoption of the company’s industry-leading eSource products and solutions. Prior to that he was at BioClinica, where he served as Senior Vice President, Global Business Development for the company’s eClinical Solutions Division. Prior to BioClinica, Stephen served as Vice President of Information Services for Bio-Pharm Clinical Services (OmniCare). He began his career as a clinical data programming manager at SmithKline Beecham. Stephen holds a Master’s Degree in Computer Science from Villanova University and a Bachelor’s Degree in Mathematics from Ursinus College.

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