This blog is the third part of a series on preparing for introducing a major new system into the Regulated Product process for Life Science sponsors. This is appropriate for all Pharmaceutical and Medical Device-related companies. The specific topic is Getting Ready for IDMP starting with an understanding of your internal Information Architecture.
My intention with this edition is to propose a pragmatic approach to prepare you for the coming changes. We spoke in the last edition about understanding where you are now through developing an Information Architecture to describe your current state. I will now focus on what to do next.
Document Your Vision
You need to understand what you want your business to become. Pick a timeframe, perhaps 5 years, and document your vision of what you want your business to be. If you are a one-product company now and want to have 4 products on the market within 5 years, document that. If you currently submit for approval in 3-4 countries or regions now, and want to submit globally to 40 countries, document that. If you want to follow closely emerging regulations and be prepared to become compliant with them ahead of deadlines, document that. Take into account that whatever you describe needs to be realistic.
The differences between your current capabilities and Information Architecture to what functionality and data you see needed for the future are the gaps to be filled or bridged. A comprehensive Gap Analysis should be performed so it will be possible to estimate the effort and resources needed. This work must include not only high level features and functionality but also the mapping of data extensions that will be required. For instance, there are 59 elements of data required today for submitting XEVMPD records to the EMA for all products. To fully comply with the full IDMP data model, the number grows to about 350, but even the first iteration of IDMP will require 92 elements. That’s a 50% growth in information just for the first submissions. Authoritative sources for the additional 33 elements will have to be determined. I have heard repeatedly an estimate that up to 85% of the required data can be found in unstructured content (documents). Searching and extracting that data for inclusion in IDMP submissions can be a laborious process and automation will be tricky. Quality issues may also appear between multiple sources.
The next step is to define the strategy to achieve your vision of the future. The planning should be broken into realistic phases to address the gaps where each can likely be achieved in a timeline of 6-18 months. Each phase must have a measureable (and realistic) return on investment. There can be segments of the objective that are less tangible and cannot be easily measured for success – document those as well. They will become guiding principles for the effort. However, the definition of MEASURABLE objectives is critical because you will be held accountable for achieving them by senior management. And it is to those measureable goals that management will judge your success. Those measures will also contribute to Change Management (your management of the perception and acceptance of the changes these systems will impose on the user community).
Setting measurable goals and defining methods for measuring and reporting on your progress may seem to be superfluous, but it is not. Build your approach and project plan with measures in mind. It will pay back benefits many times over. There are several key characteristics of designing these measures that will make a difference:
- A few measures should provide instantaneous insight. Examples of these could be:
- IDMP Submissions submitted over past 30, 90 and 360 days
- Current and average time to compile and submit applications for new and legacy products
- A few measures should assess the long-term changes needed to meet emerging business conditions. Look out 3-5 years. This might include a product release timeline with submissions for various products checked off
- And some measures should help assure compliance to emerging regulations such as IDMP, SPL and ICSR.
- Don’t forget to include measures that assess the business process for efficiency and/or effectiveness, not just use of the software.
- Create a dashboard and automate the measures where possible. Change Management will be more effective. Effective dashboards require you to discover ways to make the maintenance sustainable.
Changes in systems and processes effect people. Acceptance by both users and the company overall will require open and frequent communications to smooth out the bumps. People will struggle with the changes. As people are closer to the project, the better the buy-in. They more clearly see the value that the changes will provide. Two key areas should be communicated:
- Report progress with the Project and a forecast of next steps and timing to help set expectations.
- Report on defined measures so people will look forward to accept the project for the values expected.
I recommend that a project include selecting champions in different areas of the business affected. Keep them close to the project and they will let information flow out through informal channels. They will also begin to take ownership for the changes, take pride in communicating positive messages and help to assure positive outcomes.
The impact of change to achieve IDMP success covers multiple departments and disciplines. It is crucial for all the components of this approach to be followed. Ownership and oversight for such a project that includes such a wide user community needs to be planned and carefully executed.
I wish you the best with your projects, especially those that have complexity such as IDMP. Get ready. Start the work now so you will not be surprised and unable to be compliant on the target dates for implementation. And you will have the confidence that you have covered most of the extenuating circumstances.