Complex and large life sciences informatics projects are intimidating but sometimes unavoidable. As many life sciences organizations have grown, they have accrued various informatics systems that can create data silos, inefficient workflows, and roadblocks to meeting stringent U.S. Food and Drug Administration (FDA) regulations or getting value from their data. It can be hard to know where to start in addressing the resulting issues. Developing a comprehensive plan for all data across the organization is an important step that should be considered in any informatics project.
A Laboratory Information Management System (LIMS) or data platform can streamline operations, enhance data integrity, and ensure adherence to regulatory requirements. However, harmonizing on one LIMS or platform or transitioning to such a system from an older one requires technical expertise to minimize impacts on multinational life sciences organizations. A project leader who understands the scientific processes and data while also having the technical expertise is a rare find, yet a necessary one for success. Their value cannot be underestimated.
This blog will address a strategic approach to laboratory informatics planning in a large life sciences organization and why it’s worth having a project leader with scientific and technical expertise at the helm.
Life sciences organizations choose an informatics solution for many reasons, but chief among them are the desire to improve laboratory efficiency, ensure data accuracy, and achieve regulatory compliance. In recent years, the reasons have broadened to include comprehensive access to organizational data that enables the use of artificial intelligence and machine learning. A platform or other laboratory informatics implementation positions labs to support expanded operations and meet increased production demands.
However, the implementation process can be challenging, disruptive, and time-consuming. Migrating data from legacy systems to the new system requires meticulous care to avoid data loss or corruption. Integrating with existing instruments or enterprise systems, such as an enterprise research planning (ERP) system or manufacturing execution system (MES), can be necessary for seamless operation. Additionally, the need for thorough training of laboratory staff is always addressed to ensure they can effectively use the new system. These tasks need to be accomplished within tight project deadlines to avoid interference with ongoing research and production.
A scientifically trained technical implementation expert can be an asset in this process as a guide through the entire deployment. Such experts should be well versed in project leadership, technical delivery and scientific knowledge to ensure the implementation stays on schedule and within budget. With a large informatics project involving multiple teams, it makes financial sense to minimize risks through resources for success. If your internal resources do not have the needed blend of expertise, there are outside sources for scientific, and technical leadership. As they do this work every day, outside resources have expertise with not only the laboratory workflows and processes but also the deployment of new informatics systems or platforms.
Hiring a project leader with a technical and scientific background can save your organization money and help you reduce risks in the long run by:
The skills embodied in a technical, scientific project leader ensure that your life sciences informatics project has minimal impact on the day-to-day laboratory operations and is achieved on time and within budget with all the required functionalities.
CSols Inc. technical leaders begin any strategic engagement by conducting a thorough needs assessment to understand the client’s specific requirements. The background that our consultants have in laboratory work and lab informatics provides a depth of understanding our clients can draw on. We build relationships of trust and professionalism with clients, managing the end-to-end implementation of whatever best fits the client’s needs (instruments, platforms, or enterprise systems in addition to laboratory informatics systems).
Clients are encouraged to begin by considering all their data inputs and the questions they want that data to answer. Access to all data across the organization will be necessary to meet the needs of Pharma 4.0. We help clients identify what sources of data exist across the organization, how those sources should interact with one another, and in what form the data outputs should be visualized.
Within large complex projects, there are often decisions around which system, tool, or technology solution is the best fit. A technical, scientific informatics expert can look at your data needs, help you choose the appropriate informatics system or platform, and customize that system or platform to meet the specific workflow and regulatory requirements of your pharmaceutical lab.
For some projects, the use of extract–transform–load (ETL) tools or developing complex SQL statements is required to pull legacy data or get data from one system to another. The technical, scientific project leader can advise on ways to interface instruments or other systems to increase data access and provide a dashboard for improved data visualization. They can provide comprehensive training sessions for laboratory staff, ensuring proficiency in using the new system.
Lastly, system, instrument, and interface validations are performed to confirm that the setup meets all regulatory standards and operates correctly. When you engage a technical, scientific project leader, each of these steps will be planned for in the statement of work.
Each laboratory informatics project is unique, due to varying data sources, integrations with multiple legacy systems, and customizations to support specialized workflows. Large complex projects are even more unique in that they have many parallel efforts going on at once, each with different needs yet all interconnected.
Taking a holistic view requires the blended background of science, technology, and delivery. The benefits realized from holistic planning are substantial, once the hard work has been done.
The holistic plan and ONE team view that CSols feels is critical spans project inception, organizational communication, and change control through to system deployment, testing, and support. The project doesn’t end until adoption is stable. The implementation of laboratory informatics systems or platforms can be transformative for pharmaceutical laboratory operations if they take this holistic approach. If not, the risk of rework, project failure, and incomplete adoption are high.
Does your lab need technical, strategic help for your next large informatics project?
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