The pharmaceutical industry will undergo significant changes this summer. A set of standards for the identification of medicinal products (IDMP) from the European Medicines Agency (EMA) will take effect in July, requiring the whole industry to apply the terminologies released by EMA. The changes have raised many concerns regarding how data is managed across the industry.
While pharmaceutical companies recognise the urgent need to take action to meet the EMA deadline, the real challenge is applying a speedy, mechanised process to limit resources needed to achieve compliance. Companies face the challenge of organising huge amounts of unstructured data, which resides in silos across the business, with no formalised cataloguing method.
Automate the process with an IDMP solution
Many have already begun the process of locating these data sources within their organisations and mandating that data quality becomes a top priority across the operation.
Once that task is complete, the logical next step is to map and standardise the source data to the new data fields. Data must be extracted, parsed, standardised, matched against controlled vocabularies, enriched and transformed to comply with the IDMP standard.
One option is to assign medical experts to manually review the data and re-enter it into the new system according to the new controlled vocabularies. This is an expensive, error-prone process and not the most viable option.
Instead, pharmaceutical companies can use data analytics and automation technology to speed up the process, calling in experts to verify the data as a cross-examination exercise.
That solution (an IDMP solution) will consist of two main components:
- An application and gateway to exchange information between pharmaceutical sponsor and authorities.
- A data hub to integrate, cleanse and IDMP-standardise data from multiple data sources, and verify data according to specified controlled vocabularies.
Better collaboration across the industry
One of the advantages of this unified IDMP data hub is that it will improve collaboration and information sharing between pharmaceutical companies, manufacturers and medical professionals. It will also standardise the data input system across the industry, ensuring a more effective data management roadmap for future innovation and patient care.
Unfortunately, the pharmaceutical industry is still very much in the Wild West when it comes to information standardisation. Data quality is poor within individual organisations, so applying information standards across the whole sector creates further headaches for everyone.
Historically, because the cost of clinical trials and R&D is so high, companies have a laser focus on producing and launching new medicines quickly. Consistency in sharing information and proper documentation is low on the list of priorities. The EMA requirements can act as a starting point, and pharma experts can cure this pain point by changing their business culture.
Applying best practice from clinical transparency project
There are many long-term benefits to the industry from IDMP. If data is recorded and stored in a more standardised way, it opens up possibilities for sharing data that can drive efficient collaboration among drug manufacturers, researchers and medical professionals. Ultimately, if there's more quality data to analyse, there are more meaningful insights that can be extracted from it.
Find out more about IDMP regulation and how data analytics can help the pharmaceutical industry in this white paper: Crossing the IDMP Data Chasm. And be sure to check out our full range of life sciences solutions.
