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.
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.Message Presenter
Who Should Attend?
Senior professionals working with clinical data and documentation, including:
- Clinical Development/ R&D
- Clinical Leadership
- Clinical Data Management
- Clinical Operations
- Data Science
- Information Strategy & Analytics, Clinical Informatics & Innovation
- Information Technology, R&D IT
- IT R&D Business Partners
What You Will Learn
Participants will gain insights into:
- The growing complexity of clinical data
- The benefits of using a Statistical Computing Environment
- Best practices for implementing data standards through a clinical Metadata Repository
- Customizable solutions to clinical data needs
Quartesian was formed in January 2003, headquartered in Princeton, N.J. with the goal of providing “Clinical Data Your Way” to its clients. This is accomplished by providing clinical data services faster, more efficient and cost-effective than ever thought possible. The founding members of Quartesian rely not only on their technical expertise, but on their experience as past clients of clinical service providers. Quartesian prides itself on its flexibility, responsiveness, adherence to client specifications and timelines for all projects conducted anywhere in the world. We have worked for over 125+ pharmaceutical, biotechnology and medical device companies with 100% repeat business and no change orders.
Our business model brings together domestic and off-shore staff with minimum overhead and maximum efficiency within a framework of validated computer systems, regulatory compliance and industry best practices. Our long company history, wide geographic presence, high quality standards, cost effectiveness, faster turnaround time, and therapeutic expertise as well as qualified, experienced and talented employee capabilities enhance our client benefits.