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Integration of Two Alien Informatics
Landscapes

Our Customer

The customer was a French multinational pharmaceutical company whose US entity entered into a M&A with a mid-sized American biotechnology company. This merger created two alien informatics landscapes within the same company and additional challenges with orphan data, compliance standards and lost research collaboration opportunities. The resolution to these challenges was time-bound - to be completed within 3 quarters due to budgetary restrictions. Considering these needs and challenges, the customer reached out to Zifo for integrating the new informatics landscape with their existing landscape.

Project Background

benchling image

Informatics landscape 1

  • Specialized landscape of approximately 60 users, comprising of about 5 other tools interfacing with the Benchling ELN
  • Uniquely for large molecules protein synthesis and unsuitable for small molecule R&D
  • Cloud based with no system administrators, geared for an agile and small R&D dept
idbs image

Informatics landscape 2

  • Global landscape catering to about 4k researchers, comprising of about 15 different systems interfacing with the IDBS ELN
  • Primarily designed for small molecules research and was brittle for large molecules
  • Complex information exchange pathways and rigid data entry methods

Looking at the above comparison, a balance had to be achieved so that the best of both landscapes could be retained within a single integrated informatics landscape.

Objectives

The customer wished to develop an integrated future-state R&D informatics landscape that will deliver a rich experience for R&D groups focusing on small molecules as well as large molecules drug development.

Keeping the above in mind, Zifo identified the critical objectives for this engagement.

objectives image

Zifo's solution framework

Zifo's approach to the multi-system, multi-vendor environment took into account the current landscape, vendor capabilities, research modalities and technical functionalities of the systems in scope.

Scoping

  • Understand current state
  • Factor in different needs of small and large molecule data management
  • Map data flow between systems to avoid overlapping data tranfers
  • Consider inbuilt capabilities in COTS products and assess vendor's capabilities
  • Analyze SOPs of parent company and FDA procedures
  • Eliminate unnecessary integrations
  • Chart a timeline
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Collaboration

  • Conduct user workshops and surveys to validate scope against user needs
  • Record how research data and metadata are generated, processed, stored and consumed in both informatics landscapes
  • Closely examine technical variations such as system versioning, on-premise vs cloud
  • Examine API's already on the market for integration of COTS products
  • Involve vendors and ITS teams to discuss costs, timeline and commitment
  • Review the project timeline and identify SME's
  • Conduct future-state visioneering session
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Implementation

  • Decide integration sequence to ensure no disruption to users (iterative progression, change management plan)
  • Walkthrough of RAID with stakeholders
  • Checklist-based exit (success) criteria definition for each deployment
  • Break work into parallel phases/ units with weekly touchpoints
  • Finish all the pre-work, POs and infrastructure setup needed for external parties to proceed
  • Engage vendors and track progress as they create APIs
  • Work with all teams to avoid missing and blank data errors durig remapping
  • Set up periodic review with super users to ensure each stage is successfully signed off
  • Check other departments can also access data from newly created landscape
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Deployment

  • Complete UAT for all systems now part of combined landscape
  • Verify data is FAIR and will be so for future research as well
  • Check multi-dimensional collaboration is achieved and meets SOPs
  • Check robust scalable infrastructure is set up globally so that other departments can use
  • Ensure security measures and access privileges are uniform for all relevant systems
  • Review with senior leadership that project meets strategic goals-retrospection about projects and what went well
  • Document and hand off support and maintenance of new landscape
  • Set up post implementation support/post deployment warranty

Solution

How our science-first approach helped us organize the integration

  • We determined that the major integrations would be moving protein purification data to the COTS protein registration system and assay data to the in-house data warehouse.
  • Both the global systems were built to accept data in highly structured formats but were accessed by all the global R&D teams, making this critical for the success of the integration project.
  • In order to ensure data integrity for the new informatics landscape, the Zifo team determined what experimental data (i.e. early assay development experimental data, basic protein synthesis, etc.), would remain only within the Biologics ELN landscape and be department specific, versus what data (i.e. low to medium throughput assay data, SOP required data, potential target protein, etc.), would be exported to the larger landscape.

How our experience dealing with multiple research groups, geographies and associated ambiguities helped us execute this project

  • An important step to ensure a successful merger of the landscapes was to identify the location, type and level of detail of data that needed to be integrated.
  • Zifo consultants surveyed the consumers of the data in the larger company to understand what data they needed to access in different systems. We then worked with the producers of the data to understand specific function and storage location of each type of data produced in the Biologics ELN.
  • A unique challenge in this project was that the acquired company's IT department had been restructured in the M&A and therefore many of the system documents were outdated. To overcome this, we analyzed internal data flows so that no integration points were overlooked.
  • Based on our analysis, we identified like types of data in both landscapes in order to map data and metadata into the target data landscape.
  • We came up with the following global arrangement of systems. Several other systems, which the small molecules ELN currently integrates with, were evaluated and eliminated as unnecessary for this integration.
integrated landscape image

Successful Implementation

  • Considering the many COTS systems involved, we now brought the Biologics ELN vendor to explore specific API creation options. After understanding the inherent restrictions with the APIs, in-house template creation and restructuring of data storage within the Biologics ELN was undertaken to facilitate easy data transfers.
  • R&D representatives from the different clusters were also involved in this process, thus helping figure out the best way to restructure data transfer with minimum disturbance to exiting workflows.
  • Zifo consultants engaged with the vendors and parent company's ITS to understand the technical details of the API. Zifo ensured the work was broken into parallel workstreams for the vendor and the ITS teams while tracking weekly KPIs. Once the APIs were deployed, we then oversaw the UATS.
  • Zifo then reviewed feedback from final customers - both the consumers and the producers of the data - and ensured required incremental improvements were done before obtaining user sign-off.

Implementation benefits

benefits image

The achievement of all objectives, positive user feedback and stakeholder sign-off concluded the project successfully.

Let's Build Together

Contact our expert to explore how we could help you

author image

Sruti is a Scientific Informatics Analyst at Zifo RnD Consulting and is based out of Boston, USA. Her focus is in designing IT and Data solutions for Pharmaceutical research.

She has helped our customers with :

  • Analysis of major ELN platforms for global enterprise implementation
  • RFP and RFI evaluation in collaboration with user workshops and stakeholder requirements
  • ITS integration of biological and small molecules research groups as part of M&As
  • Analysis of PK/PD visualisation tools that are compatible for cloud platforms
  • IT business analysis of ontology and data model creation

Sruti can be reached at sruti.s@zifornd.com

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