A global biopharmaceutical company focused on metabolic disorders, gastroenterology, neurology, inflammation and oncology had its sites at multiple locations around the globe for product manufacturing, quality control/testing, and development. These sites operated in silos in terms of the informatics landscape. Business harmonization across the company was not a priority, which posed a challenge in transforming the research data into knowledgeable information for future use.
The company was interested in improving the informatics solution in these sites by selecting and implementing a global Electronic Laboratory Notebook (ELN). The company chose Zifo as their Laboratory Informatics Consulting Partner for this.
Who can take advantage
of this case study?
- Any organization evaluating ELN landscape or purchasing ELN.
- Companies looking to standardize laboratory informatics vendor selection methodologies with in-siloed informatics environment.
- Business groups of different priorities faced with specific laboratory informatics solutions
Some of the issues the company was experiencing in their R&D sites that they hoped to remedy:
- Lacked integration in the informatics process across departments
- Sites had in-siloed and fragmented ELN landscape
- Had unsustainable eNotebook footprint
- Sites used paper notebooks
- Priorities differed for different Therapeutic Areas
- Most of the sites were on outdated/ageing platforms
In order to address these problems, the company chose to select, implement and integrate a global ELN solution that would improve the overall reproducibility and traceability of data and efficiency of its all R&D sites. Zifo was tasked with executing the assessment phase of the ELN project, which included conducting Business Process Analysis and coordinating the ELN Vendor Selection Process.
Business Challenges and Goals:
Eliminate fragmented ELN landscape and select a global ELN for R&D
Deploy to critical global functions with strong integration needs
Transition the existing products to new platform over a defined time period (approx. 3-5 years)
Our recommendation had digitalization as the key solution principle since the industry is moving towards a digital R&D environment in order to better achieve business goals and compliance. The need for an evolution to digital R&D lab can be empathized through the below picture.
- Data centric
- Workflow Automation
- Integrated Workflows
- Master Data
- Data Science &
- Platform based solutions
- Enterprise architecture
- Cloud hosted
- Data Warehouses/ Marts/
- Performance / Scalability
- Search Complexity
- Instrument Integration
- Data overload
- Decision centric
- Data to Information
- Real-time Access
- Semantics Querying
- Enabling Decisions
- Ontology Development
- Robotic Automation
- Machine Learning
- IoLT / Wearbles
Zifo's Scientific Informatics Consultants performed a threefold analysis focusing on Functional, Technical and Supplier Capabilities to understand the current state challenges and define future-state capabilities.
The key drivers related to ELN evaluation were
Instead of the traditional BPA process Zifo tailored and developed a risk-based BPA methodology to execute the ELN evaluation by following the below mentioned steps:
User interviews to focus on buisness perspective
Key Requirement documents
Potential Use cases with focus on risk factors
RFP technical assesment
Implementation roadmap with risk mitigation approaches
Zifo has developed and refined a methodology based on best practices and implementing, observing and measuring results for scientific and laboratory-based organizations.
Example Requirement document:
Example Score Card based on vendor responses and use cases:
ELN Evaluation Highlights and Benefits
- Assessment was completed within 5 months and successfully selected a robust ELN platform for R&D wide deployment.
- Provided a controlled vocabulary to eliminate misunderstanding of the requirements.
- Created high-level implementation plan to address gaps in the informatics landscape.
- The implementation plan was realistic and sequenced to avoid disruption to ongoing laboratory operations as it was based on business group priorities.
- Given that the requirements developed were constrained to business improvements, the client felt confident that their new ELN will deliver significant business value for their organization.
Let's Build Together
Contact our expert to explore how we could help you
Uma is a Business Systems Analyst at Zifo RnD Solutions and is based out of USA. Her focus area is ELN evaluation, Vendor Selection and Business Analysis.
She has engaged with our customers for:
- Voice of Customer interviews
- Documentation of user requirements
- Business Process Maps
- Defining use cases
- Market Research and creation of ELN capability matrix
- Vendor Demos
- Strategic implementation road maps
Uma can be reached at email@example.com