This article is the first in a series that will reflect on the activities that can or should be initiated now or soon in order to be prepared for the first IDMP reporting deadline . This first article reflects on IDMP IT System architectures options.
Even though the scope for the first IDMP reporting is not fixed, the current plan from EMA is unconfirmed, the ISO standard is being updated and changed and the GInAS application/setup is not final – we are of the opinion that the below activities should be in progress or initiated very soon:
- Selection of IT system/architecture and preparing/initiating an RfP/vendor selection
- High-level planning of the IDMP Program
- Initial Data Analysis to discover areas for data capture and data cleansing
- Investigating the GInAS system and start collecting structured substance data
Based on the knowledge that we have found by following webinars, participating in conferences and doing market research we have found that at least four different options for IDMP IT system architectures are or will become available.
Simple Webtool from EMA:
At the ISO IDMP Information Day held at EMA on 23 June 2015 – EMA representatives stated that a simple webtool like EVWEB would be provided for reporting of IDMP data.
Based on the current information the tool will most likely be cheap or free of charge and data will have to be entered manually like it is the case for the EVWEB tool.
Risks are that the tool will not be available until very late in respect to the EMA proposed implementation plan. The tool might have performance issues, like it is the case for the EVWEB tool, when larger amount of data needs to be entered. Data extraction options, reporting and review and approval workflows might not be very advanced, if at all available. Conditions for GxP use of the tool is unclear and might be put on the individual pharmaceutical company to implement.
For the first iteration the amount of work to implement the tool will probably be similar to the work done when xEVMPD reporting was implemented. Since only manual data entry is possible number of products, registrations and related IDMP data must be considered before choosing this solution as your IDMP reporting tool. One should also consider the full IT system landscape and from where the IDMP data needs to be extracted – what is the quality of the extracted data and how well is Master Data aligned with the other systems in scope for data extract. This will give some indication of the amount of manual work that will be needed for the full implementation.
Overall it is our impression that the web tool will probably only be useable for companies with only a few registrations. The amount manual work when considering data in iteration 3 and 4 will simply be too much if you have a larger number of registrations.
Should this solution be the right solution for your company a lot of implementation activities might not need to be initiated until after the release of the “Final EU Implementation guideline for Iteration 1” (scheduled for Q1 2016) and the final “EU Substance Implementation guideline for Iteration 2” (scheduled for Q2 2016).
We would estimate 6-9 month to handle the Implementation of the webtool in a GxP compliant way. This estimate does not include the needed data collection and data cleansing that needs to take place in order to be prepared to actually start the data entry once the surrounding GxP processes are completed.
Integrating IDMP into the Regulatory Information Management System:
A number of vendors are communicating that they will implement the IDMP data model into their existing RIM solution, we have at least identified the following vendors which are promoting this approach:
CSC (Regulatory Tracker)
If you already have a RIM system from a vendor who is promoting this strategy, it will most likely be a path with less effort and costs to upgrade your existing system. This means that your existing maintenance organization and existing GxP baseline can be used for implementing a system that supports IDMP reporting.
On the other hand the RIM system may not be the best suitable choice for storing IDMP data. NNIT has written an article called “Five reasons why your RIMS system may not be suited for ISO IDMP” that lists the following reasons for not storing your IDMP data in existing RIM systems:
- The enormous amount of data and its diverse sources, only 20-25% of ISO IDMP data will reside in the RIM system
- RIMS is originally designed for another purpose, building ISO IDMP into a RIMS system is not simple, as there is no clear way of presenting the extensive set of ISO IDMP product data to the user in an application that was originally designed for a completely different purpose
- There is a clash in the users of RIMS and IDMP submitters, the employees who access RIM to maintain a registration are not the same as those who maintain product data for submission to EMA. This tendency will be even stronger for ISO IDMP.
- Risky interdependencies between ISO IDMP and RIMS, Building ISO IDMP into a RIMS system may jeopardise the stable operation of the RIMS system by necessitating further system updates in connection with changes in the ISO IDMP guidelines or HL7 messaging standards for gateway submission
- Data integrations are indispensable for IDMP, the extensive set of data required for ISO IDMP will require data from a number of other systems in the company, and it is not likely that all this data can be managed manually (or it will be too expensive to manage it manually)
Please read the full article for more information.
In respect to data integrations there are highly advanced systems on the market for handling of Master Data that can interface to almost any system or database. These systems also have highly configurable workflow options that can be used for transformation and change of data from IDMP source systems to fit the IDMP data model and ensure alignment of data. At least consider the complexity of your IT system landscape, if your future RIM system can provide the needed interface functionality to other systems, or if you will need customized interfaces to each of your IDMP source systems. Also consider if the standard integration functionality that is provided by the Master Data Management systems on the market would be a better solution. Same considerations should be made in respect to the needed transformation and alignment of data to the IDMP data model and Controlled Vocabularies.
Should this solution be the right solution for your company you would probably need to plan an system update once your vendor has released the new version of the software that contains the IDMP data model. Given that the vendors will have to include the changing IDMP data model in their software release they can probably not initiate the final software release process until the “Final EU Implementation guideline for Iteration 1” have been released (Q1 2016). Depending on your current RIM vendor version and if an upgrade can be done without a large data migration effort the project could take anywhere from 6-12 months.
Implementing a separate IDMP specific system:
At least two RIM vendors are communicating that they will develop a separate IDMP solution for supporting IDMP reporting:
For the same reasons that it might not be a good idea to store your IDMP data in your existing RIM system – it might be a good idea to separate the data (see bullet list in the above section). If your RIM vendor will also include the interface to the RIM system you will get all the RIM data automatically in your IDMP database by choosing this system setup without the disadvantages of combining the data.
In respect to data integrations, data transformation and data alignment to the IDMP data model and Controlled Vocabularies you would still have to consider the capability of the offered IDMP solution compared to the interface and workflow functionality offered in the Master Data Management systems that are on the market.
Should this solution be the right solution for you company you could align such a system purchase with the release of “Final EU Implementationguide line for Iteration 1” (scheduled for Q1 2016) and maybe also with the release of the final “EU Substance Implementation guideline for Iteration 2” (scheduled for Q2 2016). Any activities needed to prepare the purchase could be completed before to optimize the remaining activities needed for IDMP implementation.
Interfaces to other source systems or manually input of data will still have to be configured (if you RIM vendor’s IDMP system has that option) or customized. Should a lot of data conversion be needed in respect to IDMP data residing in the non-RIM IDMP source systems this must also be taken into account either in the interfaces that will have to be customized/configured or changing the data in the source systems. We would estimate 9-15 month to handle the full implementation of such an IDMP tool.
Implementing a staging area and an IDMP reporting component:
Vendors with in the Master Data Management market are also proposing solutions for IDMP. Not all solutions include components that can be configured for IDMP reporting so if such a vendor is chosen an additional IDMP reporting component must be added. At least the following vendors are proposing their master data management software as a possible solution for IDMP:
Should you chose to implement an IDMP specific reporting component basically any Master Data Management solution could be used to build the staging area shown on the figure – in that case the list is not limited to the vendors listed above.
Compared to the other IDMP architecture options these systems have out-of-the-box interface connections to almost any data source and they are highly configurable in respect to transforming the data and aligning them to the Controlled Vocabularies. They also have remediation workflows if data should not follow the defined path or quality so that warnings will be raised and correction can be implemented.
Currently not a lot of standalone IDMP reporting tools are available so this part might have to be customised if it is not included in the package from your Master Data Management vendor. Another option is to use the IDMP reporting components from ArisGlobal (agIDMP) or EXTEDO (RImanager/MPDmanager) to handle the specific IDMP reporting functionality.
On the downside these systems seems much more expensive than the systems offered by the RIM vendors. Larger support organizations will have to be established and some of the solutions – even though they are configurable – need persons with technical skills to be implemented and maintained.
What would be the right system for your organisation needs to be based on analysis of IDMP data, processes, IT system landscape and long-term costs comparing solutions including manual labour compared to more automated infrastructure.
Should this solution be the right solution for you company you could synchronize such a system purchase with the release of “Final EU Implementation guideline for Iteration 1” (scheduled for Q1 2016) and maybe also with the release of the final “EU Substance Implementation guideline for Iteration 2” (scheduled for Q2 2016). Any activities needed to prepare the purchase could be completed before to optimize the remaining activities needed for IDMP implementation. We would estimate 12-18 month to handle the full implementation of a staging area and an IDMP reporting component.