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Here at Intraversed, we believe business information management is essential to business success. It’s part of what we help establish with the Intralign Ecosystem.
But if you’re not convinced it’s that important, here’s a case study about a client of ours who saved hundreds of thousands of dollars – over seven hundred thousand, to be more accurate – thanks to the work we did with them, implementing high quality business information management practices.
Turns out, an Excel spreadsheet option was enough, no expensive industry-specific software purchase necessary.
Here’s the story.
A small international pharmaceutical research company – let’s call them DrugCo – operates in various countries (Australia, New Zealand, North & South American, Europe, Ireland and the UK).
As with all drug research organisations, DrugCo needed to follow the industry regulatory reporting requirements, which included reporting all adverse events. Such events constitute significant risk for DrugCo. Naturally, they were highly concerned that their current reporting system deliver adequate assurance. The system was paper-based initially, with details then being entered into an Excel spreadsheet. They knew that they couldn’t honestly say this system was sufficient and robust enough to ensure they met regulatory requirements.
A new USA-based trial was getting underway and DrugCo needed to meet FDA requirements for adverse event reporting. They needed to review and upgrade their system to ensure compliance.
Larger pharmaceutical companies use customised, full-service software that is certified pharmacovigilant compliant (meaning the software has regulatory activity built-in and is therefore approved by the FDA as adequate for adverse event reporting).
DrugCo didn’t have the budget for such software ($700K+) but couldn’t see another option.
Until they found Intraversed.
We conducted a thorough evaluation of DrugCo’s business processes, including the protocols for data capture, quality assurance, data entry and issues management.
This made one thing very clear:
DrugCo’s primary risk wasn’t a lack of expensive software that recorded things in a specific way.
It was their end-to-end processes.
Those faulty processes could have easily resulted in information being lost on its way through them, regardless of the software used for storage.
That could mean legal risk for DrugCo.
And the potential to incorrectly assess the efficacy of the drug being trialled.
That could mean lost investment, revenue and business growth (if an effective drug were to be deemed ineffective).
And, although unlikely, it could also pose a danger to health, or even life, if a drug’s serious side effects were not detected.
The core problem lay in DrugCo’s own processes and their inability to properly manage the information being collected and stored.
An expensive piece of software would not solve these issues.
Having identified where the source of the problems actually lay, Intraversed were able to develop a plan that gave DrugCo the robust reporting processes it needed and the risk mitigation it wanted.
The plan established solid and effective business information management.
By clarifying definitions for key data terms and metrics, and enforcing usage compliance with those definitions, everyone knew what was to be reported, what was not, and who the reports needed to go to.
These definitions reflected the real-world accountability for the processes being referred to by the terms.
In this way, term definition work establishes information governance.
We then set up requirements for data capture and validation, which could be clearly communicated, thanks to definition work now completed.
Reliable security measures could now be implemented, with audit trails and cross-checking processes in place.
And once we’d established solid backup and recovery processes, so data security was ensured, it was very clear that their Excel-based system simply needed to be upgraded to reflect the new procedures and requirements.
No further software purchase was necessary.
DrugCo were not aware of the source of their risk. They believed the fancy presentations of software sales people that seemed to promise security and assurance.
But thanks to their budgetary restrictions, they were compelled to look elsewhere to see if they could achieve the regulatory compliance they needed at a fraction of the cost.
Turns out, Excel was enough. We amended their current system to reflect the regulatory requirements and the necessary governance, and DrugCo were 100% compliant.
A $700k software purchase was avoided.
But more than that, the $700k software would NOT have resolved the real risk DrugCo faced. Without the background analysis work to uncover the flaws in their processes, and the definition work to clarify what information those processes really needed to provide, new software would simply have transferred faulty systems into a shiny new package.
Software companies work hard at developing industry-specific systems but they’re not always the best solution for businesses in that space.
KNOW the business problems your company is facing…don’t just look at the surface need (proving regulatory compliance) but actually investigate what’s going on under the hood to determine where your risk of non-compliance lies.
In our experience, the cause of such business problems is not lack of adequate software.
It’s far more likely to be the result of ineffective business information management processes.
Want good IM?
Catalogue all relevant business processes and artefacts involved.
Define terms for metrics and key data items, organisation-wide, and then enforce alignment of all processes and information artefacts to those term definitions.
Establish governance over terms (that is, ownership and accountability), and by association, governance over the processes and information artefacts is established.
Develop a solid information issues management process.
If you’re struggling with this – we can help. Why not talk to us over coffee and let’s see if we can help you like we helped DrugCo.Follow us on LinkedIn
Mark is a co-founder & Chief Development Officer at Intraversed, helping organisations establish the Intralign Ecosystem, an award winning information management & governance methodology, to achieve reliable information, stable tech spend & greater IT project success.
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