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Boosting Research and Clinical Efficiencies through Master Data Management (MDM)

Kevin Kirkemo

Consultant, Life Sciences Consulting

Danielle Gorder

Consultant, Life Sciences Consulting

Jeff Kim

Global Head of Life Sciences Consulting
Blog
  • Life Sciences & Healthcare

The biopharmaceutical industry is facing several challenging realities within the drug discovery market: The average cost of drug development is rising, time-to-market is becoming longer, and competition within the industry is increasing. These challenges are not new, but digital technologies have allowed for the disruption of old processes with new and progressive solutions.

Today, the biopharmaceutical industry is lagging behind other industries in their implementation of advanced technological solutions. Master data management (MDM) is one such technology which could be applied in multiple forms throughout the R&D and clinical trial processes to provide both cost savings and industry differentiation. This blog discusses four common business needs which MDM can address:

  • Data integration across the R&D organization
  • Actionable insights to assist in corporate decision-making
  • Improved patient data collection at the clinical trial level
  • Complete data lifecycle visibility for regulatory compliance
Data Integration

Data management and integration across the R&D organization is key to an efficient drug development cycle. Proper integration of critical data sources is a major challenge facing the data-heavy biopharmaceutical industry today. By properly integrating all laboratory data streams into one cohesive network, companies can better leverage the latest data management tools to save time and money. For example, it’s been estimated that the industry spends hundreds of millions of dollars annually (and countless hours) on simply transferring data between systems. By more efficiently integrating their data management systems, companies would free up their R&D team to do what they do best – science!

Preclinical Portfolio Decision-Making

For biopharmaceutical companies, portfolio planning and decision-making is a time-intensive endeavor. This is in part due to the mass amounts of data that need to be analyzed before an educated go or no-go decision can be made regarding clinical or preclinical assets. By leveraging an integrated data management system, those data-driven decisions can be organized and visualized digitally in a way that cuts down on unnecessary complexity and prepares each asset for a straightforward comparison on a level playing field. This way, when it is time for the scientists to take their findings to management, a properly integrated data management system could seamlessly create automated reports with all the relevant information needed to assist in a wide array of corporate decision-making scenarios.

Patient Data Collection

Companies face an increasing pressure to differentiate their pipeline assets by demonstrating their product’s enhanced efficacy and safety profiles. For drugs to progress through clinical trials and differentiate themselves from previously marketed products, the industry is turning to studies based on larger patient groups. This approach can provide additional supporting data to regulatory bodies, yet it can also significantly lengthen trial timelines and result in large datasets. Companies recognize the need for consistent data management practices, as they follow internationally recognized regulations and guidelines for clinical trial data to meet requirements.

A challenge the biopharma industry faces is that globally, clinical trial data management of medical records is still largely captured in paper-based format. An electronic data management system would allow companies to efficiently collect, process, analyze and report data for larger patient groups across multiple clinical trial sites. Introducing a technologically enhanced MDM system would also promote data consistency and integrity, reducing trial delays due to missing or inaccurate data. While many companies may currently lack the necessary technical prerequisites for a fully integrated electronic MDM solution, they should consider how their methods of patient data collection can be modified to accommodate electronic MDM adoption.

Compliance Management

The pharmaceutical industry remains one of the most highly regulated industries, as companies must remain compliant while constantly adapting to new regulatory requirements. Companies should deploy an MDM strategy to provide a complete lifecycle view of key business data, including metadata collected throughout the R&D/clinical trial process. In order to remain compliant, companies need increased visibility for data related to their customers, distributed products and vendors to avoid regulatory issues in the event of a recall or formal inquiry. In the context of clinical trial site management, a complete and organized view of physician, patient, employee and product data reduces cycles spent on preparing that data for audit and trial submission. Most organizations are already expending resources in order to remain compliant in an ever-changing regulatory landscape. Those who adopt an MDM solution will have a clear advantage over those who don’t.

Conclusion

The biopharma industry is highly innovative when it comes to developing novel therapies using technologies like CRISPR, nanotherapies, proteomics and precision medicine. While the industry may be forward-thinking in the context of modern medicine, it lags others in its utilization of innovative digital technologies. This promotes inefficiencies across the drug development spectrum which could otherwise be avoided with the proper technological solutions.

Master data management is just one such solution which could be used to assist and extend the work done by employees currently trailblazing the future of drug discovery. With cost and competition rising, the industry must re-think traditional ways of work and embrace augmented capabilities enabled by technological change. Many biopharmaceutical companies have already begun to realize the benefits of third-party expertise in further developing their technology solutions. Such a collaboration allows companies to focus on developing innovative therapies while leveraging a trusted partner to implement a tailored technology solution.

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