This article is the second 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 in 2017. This second article reflects on high level IDMP Program planning.
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 area’s 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 will in this article propose a high level plan for the overall IDMP Implementation. The high level plan will also show that the current communicated timeline from EMA does not leave a lot of room for postponing IDMP activities must longer in respect to getting an IDMP IT system ready for the expected deadline for Iteration 1 in Q4 2017. The plan is based on the time estimates for implementation of IDMP system architecture discussed in our first article “Reflections on possible IDMP IT System Architecture options”.
Latest plan proposal from the European Medicines Agency to implement IDMP propose splitting full IDMP implementation into 4 iterations excluding veterinary medicinal products. In the figure below the first two iterations are shown and it has been communicated that the following waves be enforced with intervals of 6 months in prolongation of the plan shown in the figure.
Figure 1: Plan proposal from the European Medicines Agency to implement IDMP (reference (slide 25))
As stated in the beginning of this article there many unknowns in respect to IDMP:
- The scope for the first IDMP reporting is not fixed – which fields will be part of the first iteration?
- The plan from EMA (see figure 1) is still only a proposal, so it can still be updated and changed before a final version is presented
- the ISO standard is being updated and changed, lasts drafts have shown new fields, moving for fields between classes and new classes of data
- the GInAS application/setup for structured substance is not final – there is a meeting in Uppsala on the 7-8 of September arrange by the GInAS organisation that might provide more clarity but for now all is still work in progress
Even though the deadline for reporting on the first iteration is not that far away – so how do you plan a IDMP program? Based on what we do know we have outlined the following planning inputs:
- The IDMP architecture to be implemented must be capable of scaling from the data in Iteration 1 to the data in Iteration 2, 3 and 4.
- One could use a two system strategy – using the web tool for Iteration 1 since iteration 1 should only be xEVMPD data and many pharma companies used EVWEB for the xEVMPD data reporting. This could be a way to move forward postponing the point in time where investments in new software need be made – but it will most likely also result in parallel work once you are two implement the data reporting for the 2nd iteration. Should a two system strategy be selected one should make sure that the needed resources a cut-over activity between the two systems are in place at the implementation of the 2nd iteration.
- Planning for an implementation at the last minute in Q4 2017 is probably not the best way to go – having a 3-6 month buffer in respect to the Q4 2017 deadline would be recommended.
- Depending on the chosen IT system(s) and related activities the implementation schedule will be different. In our first article “Reflections on possible IDMP IT System Architecture options” we tried to give an overview of the different options of IDMP architecture that are or will be available on the market. Based on this article it is our impression that an IDMP IT system implementation can take anywhere from 6-18 month, but if you also consider time for a proper purchasing process you can add another 3-6 month for running a vendor selection process. If the IT system also needs an IDMP reporting component to be implemented separately we would recommend that you consider at least 3-6 months for this component somewhat in parallel with what would be the staging area implementation. In our program plan example we have proposed a 15 month implementation time for the IDMP IT system. Should you chose a more simple IDMP architecture which is also discussed in the article – you can reduce this activity in time. In the planning example we have timed the vendor selection and system implementation with the release of the draft implementation guides from EMA to ensure that software investment is not made until implementation guides are released.
- Assuming that a scalable IDMP infrastructure have been selected and will be in place for Iteration 1, implementation of Iteration 2, 3 and 4 should be planned for sections of approximately 9 months leaving 3 months for analysis and design, 3 months for development and 3 months for validation activities for each iteration. Phases might be overlapping and executed in parallel.
- The ISO standards are only undergoing small changes so it is our proposal that an IDMP data analysis on the data in your company’s current IT systems are mapped to the IDMP data model. This will give you an overview of how much data that you will be missing in order to be compliant to creating a report for iteration 1, 2, 3 and 4. This analysis effort could also contain a quality element looking at data for different products to create an overview of the data quality in each system to create some idea of what level of data cleansing and alignment that is needed. Given the size and complexity of your IT landscape such an activity can take anywhere from 3-6 months.
- Pending on the result of the IDMP data analysis you IDMP program should following the analysis start a data capture, data cleansing activity – data process track. Each gap field or area identified in the analysis should be evaluated in respect to the EMA planned iterations and the current ongoing changes of the ISO IDMP data model and based on this prioritised for cleansing or capturing. We believe that an data capture and data cleansing activity will be ongoing from the end of the IDMP data analysis until the end of the program. Data capture and cleansing activities will most like be more focused on the data for the later iterations. We would think that area’s like detailed mapping of devices and device material for the data fields in package item container and package component of the ISO IDMP data model and MedDRA mapping for clinical particulars need special attention, but pending on your data there might be more or less area’s that will need focus. On the other hand the draft implementation guides are not yet detailed enough to support the initiation of the mapping work for clinical particulars so if you start now there is a high likelihood of ework later. The IDMP data analysis might also lead to identification of processes that needs to be created for future data capture and definition of data responsibility for the data area’s not currently capture in the available IT systems or documents.
- The plan should also contain a track for collecting Structure Substance Information – we will assume that the GInAS system will be used for this part. It is not easy to estimate the duration of this activity. We have planned with about 12 months based on assumption that, some data collection will have to take place from unstructured data sources and knowledge will not be easily accessible and existing processes will have to be changed to ensure a good process setup for this kind of data in the company going forward.
Each of the above time estimates are guesstimates. That said the above planning reflections could be combined to create the plan shown below in Figure 2: IDMP Plan example based on planning reflections.
Figure 2: IDMP Plan example based on planning reflections
The plan example does not leave a lot of time for delay or postponing activities in the IDMP Program. The plan shows that activities like:
- Selection of IT system architecture and preparing/initiating a vendor selection should be in progress or start soon
- Initial Data Analysis to discover area’s for data capture and data cleansing should be in progress or start soon
- Investigating the GInAS system and start collecting structured substance data can wait until early 2016, but it might be a good idea to monitor what happens in this area
Each Pharmaceutical Company should make their own estimates based on the individual IT system landscape, results of your own IDMP data analysis, check of data quality and alignment of data across the different IT systems in the company.
Hopefully our planning example will help you plan your own IDMP program and the activities that need to be completed before enforcement of Iteration 1, 2, 3 and 4.