Mr. Rasmussen will speak more about the topic IDMP Data Complexity compared to xEVMPD at the ISO IDMP Implementation online conference.
Quantifying IDMP effort vs. xEVMPD
We believe that many pharma companies are currently evaluating what approach to take in respect to IDMP implementation – whether the decision is to do a manual implementation as has been the case for many companies for xEVMPD or whether a digital solution is implemented with investments in software and consultancy support to handle the IDMP data. Most companies with more than a few products on the market should probably take the digital route, but what are the hard arguments to support such a decision?
Most vendors propose doing a detailed IDMP analysis to find the source data within the company, but is that enough? In pharma IT we propose to do a quantitative multi-dimensional analysis of IDMP parameters vs. xEVMPD to identify the right choice your company:
· Map system complexity (number of IT systems being source systems for IDMP)
· Map number of data fields originating from documents
· Calculate the max data volume for IDMP vs. XEVMPD specific to the pharma company
· Estimate the company-specific data availability in respect to the max data volume
· Use the above values to describe what a manual solution would look like
· Estimate costs of a digital solution vs. a manual implementation
Map system complexity
For most companies, it is possible to identify the number of systems that contain the IDMP source data. These systems will normally be found within the following areas:
· Clinical Trial Management System(s)
· Regulatory Information Management System(s)
· Production Management System(s)
· Pharmacovigilance System(s)
For xEVMPD most data originates from the Regulatory Information Management System for IDMP. We usually see anywhere from 4-15 systems being in scope to supply IDMP source data for all 4 waves.
Map number of data fields originating from documents
In their detailed IDMP data analyses most pharma companies identify 40-60% of the data as only being available in unstructured sources, i.e., documents. Therefore, we also need to specify the number of fields that will be populated based on the documents. If a Regulatory Information Management system was available at the time of implementation for xEVMPD most companies would only have a few data fields originating from documents in the xEVMPD implementation. We see this number growing from 10-20 data fields in wave 1 to over 100 data fields in wave 4.
Calculate the pharma company-specific max data volume
All pharma companies have different product portfolios, which means that the individual effect of IDMP vs. xEVMPD will be different from company to company. We propose to analyze the product portfolio and identify what the average repetition of the IDMP data classes would be for your specific company and then sum this calculation for all data classes and compare to the same calculation for xEVMPD. Remembering models are always simplifications of the truth, one should be careful in how these numbers are used, but our calculations show that IDMP max. data volume is 6-9 times larger for wave 1 compared to xEVMPD and when wave 4 is implemented the factor rises to a number between 30-40 times larger than xEVMPD, not considering the ongoing addition of batch IDs and similar transactional data in the years to come.
You can find the complete blog post here, together with other articles from Mr. Rasmussen focusing mostly on the ISO IDMP topic.