Bio-IT teams must focus on five major areas in order to improve research efficiency and outcomes
Life Science research organizations need to collect, maintain, and analyze a large amount of data in order to achieve research outcomes. The need to develop efficient, compliant data management solutions is growing throughout the Life Science industry, but Bio-IT leaders face diverse challenges to optimization.
These challenges are increasingly becoming obstacles to Life Science research, where data accessibility is crucial for gaining analytic insight. We’ve identified five main areas where data management challenges are holding Life Science research teams back from developing life-saving drugs and treatments.
Five Data Management Challenges for Life Science Research Firms
Many of the popular applications that Life Science researchers use to manage regulated data are not designed specifically for the Life Science industry. This is one of the main reasons why Life Science research teams are facing data management and compliance challenges. Many of these challenges stem from the implementation of technologies not well-suited to meet the demands of scientific research.
Here, we’ve identified five areas where improvements in data management can help drug R&D efficiency and reliability.
1. Manual Compliance Processes
Some drug research teams and their Bio-IT partners are dedicated to leverage software to automate tedious compliance-related tasks. These include creating audit trails, monitoring for personally identifiable information, and classifying large volumes of documents and data in ways that keep pace with the internal speed of scientific discovery.
However, many Life Science researchers remain outside of this trend towards compliance automation. Instead, they perform compliance operations manually, which creates friction when collaborating with partners and drags down the team’s ability to meet regulatory scrutiny.
Automation can become a key value-generating asset in the Life Science research process. When properly implemented and subjected to a coherent, purpose-built data governance structure, it improves data accessibility without sacrificing quality, security, or retention.
2. Data Security and Integrity
The Life Science industry needs to be able to protect electronic information from unauthorized access. At the same time, certain data must be available to authorized third parties when needed. Balancing these two crucial demands is an ongoing challenge for Life Science researchers and Bio-IT teams.
When data is scattered across multiple repositories and management has little visibility into the data lifecycle, striking that key balance becomes difficult. Determining who should have access to data and how permission to that data should be assigned takes on new levels of complexity as the organization grows.
Life Science research organizations need to implement robust security frameworks that minimize the exposure of sensitive data to unauthorized users. This requires core security services that include continuous user analysis, threat intelligence, and vulnerability assessments, on top of an MDM-based data infrastructure that enables secure encryption and permissioning of sensitive data, including intellectual properties.
3. Scalable, FAIR Data Principles
Life Science organizations increasingly operate like big data enterprises. They generate large amounts of data from multiple sources and use emerging technologies like artificial intelligence to analyze that data. Where an enterprise may source its data from customers, applications, and third-party systems, Life Science researchers get theirs from clinical studies, lab equipment, and drug development experiments.
The challenge that most Life Science research organizations face is the storage of this data in organizational silos. This impacts the team’s ability to access, analyze, and categorize the data appropriately. It also makes reproducing experimental results much more difficult and time-consuming than it needs to be.
The solution to this challenge involves implementing FAIR data principles in a secure, scalable way. The FAIR data management system relies on four main characteristics:
Findability. In order to be useful, data must be findable. This means it must be indexed according to terms that researchers, auditors, and other stakeholders are likely to search for. It may also mean implementing a Master Data Management (MDM) or metadata-based solution for managing high-volume data.
Accessibility. It’s not enough to simply find data. Authorized users must also be able to access it, and easily. When thinking about accessibility—while clearly related to security and compliance, including proper provisioning, permissions, and authentication—ease of access and speed can be a difference-maker, which leads to our next point.
Interoperability. When data is formatted in multiple different ways, it falls on users to navigate complex workarounds to derive value from it. If certain users don’t have the technical skills to immediately use data, they will have to wait for the appropriate expertise from a bio-IT team member, which will drag down overall productivity.
Reusability. Reproducibility is a serious and growing concern among Life Science professionals. Data reusability plays an important role in ensuring experimental insights can be reproduced by independent teams around the world. This can be achieved through containerization technologies that establish a fixed environment for experimental data.
4. Storage Solutions
The way your research team stores and communicates data is an integral component of your organization’s overall productivity and flexibility. Organizational silos create bottlenecks that become obstacles to scientific advancement, while robust, accessible data storage platforms enable on-demand analysis that improves time-to-value for research applications.
The three major categories of storage solutions are Cloud, on-premises, and hybrid systems. Each of these presents a unique set of advantages and disadvantages, which serve specific research goals based on existing infrastructure and support. Organizations should approach this decision with their unique structure and goals in mind.
Life Science research firms that implement MDM solutions are able to take important steps towards storing their data while improving security and compliance. Master data management provides a single reference point for Life Science data, as well as a framework for enacting meaningful cybersecurity policies that prevent unauthorized access while encouraging secure collaboration.
MDM solutions exist as Cloud-based software-as-a-service licenses, on-premises hardware, and hybrid deployments. Biopharma executives and scientists will need to choose a deployment style that fits within their projected scope and budget for driving transformational data management in the organization.
Without an MDM solution in place,Bio-IT teams must expend a great deal of time and effort to organize data effectively. This can be done through a data fabric-based approach, but only if the organization is willing to leverage more resources towards developing a robust universal IT framework.
Many Life Science research teams don’t adequately monetize data due to compliance and quality control concerns. This is especially true of Life Science research teams that still use paper-based quality management systems, as they cannot easily identify the data that they have – much less the value of the insights and analytics it makes possible.
This becomes an even greater challenge when data is scattered throughout multiple repositories, and bio-IT teams have little visibility into the data lifecycle. There is no easy method to collect these data for monetization or engage potential partners towards commercializing data in a compliant way.
Life Science research organizations can monetize data through a wide range of potential partnerships. Organizations to which you may be able to offer high-quality research data include:
Healthcare providers and their partners.
Academic and research institutes.
Health insurers and payer intermediaries.
Patient engagement and solution providers.
Other pharmaceutical research organizations.
Medical device manufacturers and suppliers.
In order to do this, you will have to assess the value of your data and provide an accurate estimate of the volume of data you can provide. As with any commercial good, you will need to demonstrate the value of the data you plan on selling and ensure the transaction falls within the regulatory framework of the jurisdiction you do business in.
Overcome These Challenges Through Digital Transformation
Life Science research teams who choose the right vendor for digitizing compliance processes are able to overcome these barriers to implementation. Vendors who specialize in Life Sciences can develop compliance-ready solutions designed to meet the needs of drug R&D, making fast, efficient transformation a possibility.
RCH Solutions can help you capitalize on the data your Life Science research team generates and give you the competitive advantage you need to make valuable discoveries. Rely on our help to streamline research workflows, secure sensitive data, and improve drug R&D outcomes.
RCH Solutions is a global provider of computational science expertise, helping Life Sciences and Healthcare firms of all sizes clear the path to discovery for nearly 30 years. If you’re interesting in learning how RCH can support your goals, get in touch with us here.