REUSE, AUTOMATE, SHARE, and COLLABORATE
The historical definition of metadata is “data about data”, or “metadata is structured information that describes, explains, locates, or otherwise makes it easier to retrieve, use, or manage an information resource”.
In the past, Study conduct was carried out by multiple business functions operating in a siloed manner, such as Data Capture, Clinical Data Management, Analytics & Reporting, Biostatistics, Clinical Operations etc with a more limited, siloed view of metadata.
Now, however, the Healthcare & Life Sciences industries are blurring boundaries and are at a stage of exploiting the potential of a variety and volume of data not only from within each individual industry but also horizontally across both. Each has multiple data sources they can derive benefit from combining individually within the industry and even across both. As the focus is moving towards “Patient-centricity”, straightforward and meaningful access to a broad variety and volume of data is a key aspect of both Healthcare and Life Sciences companies, individually or together, driving innovation at bench-side or at bed-side in the safest, most efficient and cost-effective manner; as well as utilizing data-driven insight from bench-side to bed-side or from bed-side to bench-side. This need is supported when the data representation is meaningful, and when data is made available on time; and that’s possible when that is supported by a robust foundation of metadata.
In addition, the industry is experiencing a wave of mergers, acquisitions, and consolidations, and all indications point to this trend continuing. As organizations consolidate, they bring with them their existing “legacy” data structures and formats, resulting in the need for integration of global Standards both within the Life Sciences industry itself, and also between the Life Sciences and HealthCare Industries. Such integration is increasingly begin driven by metadata concepts and context around key attributes such as “patient” and “customer”.
In this new paradigm, metadata, along with its storage and usage, has taken on a central role during the lifecycle, from Data Capture through Regulatory Submission. metadata is stored in multiple formats and types across business functions. To increase reusability, consortiums have implemented standard and customized workflows and process flows for metadata. Many 3rd party consortiums such as CDISC, MedDRA, Who Drug etc., have developed, published, and disseminated multiple versions of key study metadata and standard dictionary terminology that have become not only an integral part of study conduct, but also serve as a direct driver for the realization of cost, time, and resource savings.
This webinar discusses metadata from an overall industry perspective along with a discussion of the MaxisIT In-Stream Metadata Repository which has been implemented and can support Semantic Search, Syntactical Metadata, and Full Versioning as an integral component of the process as associated with data harmonization, standardization, transformation, analytics & reporting, including more recent adaptations of metadata concepts such as Translational Medicine and Adaptive Trials.
Key Takeaways of the webinar include the following, presented with the focus of how they can help organizations increase efficiency, automation, and compliance while at the same time managing costs.
- Understanding the various types and formats of metadata
- Reviewing the role of metadata in study conduct
- Understand metadata business challenges
- Examine the role that metadata plays in the Analytics & Reporting space
- Disscuss the concept of an MDR (Metadata Repository) – both external and internal
- Understanding the role of metadata in standards compliance
Patrick Zbyszewski, Executive Director of Project and Data Management, Onconova Therapeutics
Patrick Zbyszewski has more than 15 years of clinical/Pharmaceutical experience in the areas of clinical operations, data management and marketing. He has been employed at small biotechnology firms including Corixa Corporation, clinical research organizations such as Quintiles and INC Research and is currently Executive Director of Project and Data Management at Onconova Therapeutics. In the past 5 years, Patrick’s team was responsible for organization and presentation of data leading to development partnerships in Pan Asia and Europe, a successful IPO, as well as the execution of several clinical studies.
Jonathan Taylor, VP Global Product Strategy, MaxisIT
Jonathan Taylor is an accomplished strategist and management professional with over 25 years in the Pharmaceutical and life sciences industries. He has spent the last 12 years on the Business Side of the industry working for both sponsor and vendor companies understanding current and future stakeholder requirements, expectations and trends while being on the forefront of defining requirements for new solutions for the industry. He has a consistent record of devising strategic enhancements addressing the needs of Clinicians, Biostatisticians, Researchers, Study and Data Managers etc. Jonathan is currently involved in the design of the new vision for the MaxisIT Integrated Platform for Clinical Development and Data Sciences platform which will address the complete E2E needs of Analytics Users and Data Management users in one integrated environment.
Who Should Attend?
Business users in the functional areas of:
- Clinical Operations
- Data Management
from pharmaceutical, biotechnology, medical device companies, healthcare organizations, and CROs
MaxisIT is a premier provider of a true cloud-based integrated Platform solution and functional outsourcing services, which are focused on the entire end-to-end life cycle of Clinical Trials and healthcare delivery. Our purpose is to improve how Pharmaceutical and life sciences companies and academia leverage information and make decisions in support of clinical research and development. Our technology platform optimizes the information flow across the entire clinical value stream, from the technologies, processes, and departments to external CROs, vendors and partners. This facilitated integration across the ecosystem offers huge time & cost savings with in-time decision support for potential risks and opportunities.
From its inception in 2003, MaxisIT® has quickly grown into a completely integrated platform that is available as an enterprise cloud, software as a service, and also via our Global Clinical Services Umbrella. The Global Clinical Services Umbrella delivers both clinical functional and software expertise under one seamless, distributed framework leveraging software-driven delivery processes.
MaxisIT® leverages a rich worldwide alliance partner network to provide our customers with a lean, agile delivery model that minimizes project timelines and cost, via more efficient processes. The MaxisIT’s Collaborative Partner Network is comprised of and also welcomes contract research organizations (CROs) of all sizes, consulting companies, technology providers and clinical operations groups that share MaxisIT’s vision of collaborative growth.