New Metadata Role for Life Sciences & Healthcare

An increasing desire for integration across verticals and patient-centric business processes means that metadata automation and collaboration matters more than ever.

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 costeffective manner; as well as utilizing data-driven insight from bench-side to bed-side or from bedside 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.



“Having the highest quality clinical data and related information with efficient analytical tools available at all times is critical to managing our clinical programs and accelerating our innovation; and with MaxisIT’s Integrated Clinical Development Cloud, it was easy to achieve that across the portfolio of studies, and we were able to improve the quality of data and speed of decisions without increasing our support staff.”
Head of Clinical Projects
Multi-billion dollar pharma organization focused into rare disease
"Managing trials cost-effectively, and timely have been the biggest priorities in small biotech organizations with potential to grow; MaxisIT’s Integrated Platform just delivered that by allowing us to get faster access to data via clinical data repository, and role-based & self-service A&R platform to keep track of our clinical, operational, and administrative performance across the portfolio of oncology trials.”
Sr. Director, Project and Clinical Data Management
Oncology Biotech Company
“Implementation of MaxisIT’s clinical data repository enabled us easier, and faster access to our outsourced trials’ data in the most user-friendly manner, which improved our ability to respond to data quality issues, and conduct clinical data review in timely manner.”
Executive Director and Senior Physician Project Leader
Neurosciences Focused Business Subsidiary of one of the top 10 Pharmaceutical Companies
“Right combination of technology, process, and qualified people delivered via MaxisIT partnership enabled us to achieve above 50% reduction in protocol cycle time across the portfolio of trials, and also establish clear visibility across the trial performance.”
Head, Clinical Data Management
A Multi-billion Medical device company

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