A focus on data in Life Sciences
The pharmaceutical and life sciences industry has always been data-centric, especially when it comes to the three major dimensions of a drug product: safety, efficacy and quality. Clinical trials data focuses on efficacy and safety while chemistry, manufacturing and controls focus on the quality of the product – how it is made, packaged, shipped, etc.
Over the last decade, cost pressures and the need to improve efficiencies has led the industry to realize that data is a corporate asset. The industry has embraced the importance of collecting data, curating it and exploiting it in more meaningful ways across the entire value chain, not just a few functional areas. Now, there is greater focus on master data, data governance, data quality, integration of data, etc.
Over a decade of experience
Orion has been serving the pharma and life sciences industry with business solutions for over a decade. We help companies harness data in impactful ways to achieve business outcomes. We provide software solutions and services in areas that have traditionally been slow to exploit the power of data.
Leveraging the power of data
We believe effective information management is the foundation to accelerate product launches to global markets. We enable life sciences companies to be more competitive, efficient, and compliant through our products, strategic advisory, and implementation services across four key areas:
- Regulatory: We understand the data and information needs of the entire regulatory function. We have provided process and systems solutions for several clients by streamlining existing Regulatory Information Management (RIM) processes, designing new processes and enabling them with end-to-end technology solutions. We have a special focus on RIM solutions, including our cloud-based technology solution, ReALM® for Regulatory Intelligence, which has been an unmet need in the industry. We are partners with major software vendors, such as Veeva around Veeva Vault RIM, Opentext/Documentum, Microsoft, etc., and we are thought leaders at the DIA in defining the scope of RIM and developing the RIM Reference Model as a set of core capabilities for the industry to adhere to. For more information on RIM - click here.
- Quality: We understand the data and information needs of the entire quality function. We have provided process and systems solutions for several clients by streamlining existing Quality Management processes, designing new processes and enabling them with end-to-end technology solutions. We have a special focus on Quality Management Systems (QMS) and solutions on Veeva QMS and Trackwise. We are partners with Veeva QMS.
- Clinical/Safety: Clinical trials are becoming more complex in that they require integration of multiple data sources for better planning and execution of trials and collecting/curating data. We have enabled the integration of data across the clinical value chain to get better visibility into effective planning of trials and analytics of clinical data from trials. We have shown the effectiveness of AI/ML techniques to generate patient safety narratives and clinical study reports. We are partners with the leading Natural Language Generation provider Yseop.
- Digital Health: With data becoming the currency of operations across the life sciences value chain, there is greater need to harness the power of data using digital transformation techniques, such as AI/ML, to generate greater insights, be it for drug discovery, identifying markets, or generating revenues.
Any major digital transformation initiative requires carrying a multitude of stakeholders across the transformation journey, increasing the need for adoption of new processes and systems. Strong change management initiatives are important right from the beginning of transformation initiatives through implementation and post deployment of new systems and processes. Engaging with end-users is critical to ensure continued use and adoption of new tools.
Data quality and governance
In addition, data quality and data governance processes are key to data utilization in order to make better decisions and improve efficiencies. Orion is well versed in data unification using platforms such as Tamr and master data implementations, especially as companies get ready for IDMP implementation.
Orion business solutions for Life Sciences
We provide business solutions rooted in Digital Strategy, Experience Design and Engineering, delivering game-changing business transformation strategies and digital products for life sciences organizations looking to embark on their digital road map and deploy new processes and systems.
Learn more about ReALM®.