Tom Petty said it so eloquently in his 1981 song, “The Waiting Is the Hardest Part.” People guessed it was about the lead-up to the perfect relationship or even about anticipation of the arrival of a baby – but Tom said that it was the anticipation before playing a gig – how hard it was to wait to get on stage.
By John Bell, Industry General Manager – Life Sciences, Americas
The clock ticks slowly when we’re waiting for something we really want and the inverse is true when there’s something on the horizon we’re hoping would just go away or that we’re simply anxious about.
At the DIA RSIDM Forum that I recently attended with several of my colleagues from CSC, that’s exactly the message I heard from clients, partners, competitors and colleagues. More than 380 regulatory professionals were in attendance and I did not hear a conflicting viewpoint.
So Is Waiting the Hardest Part?
CSC invited 35 regulatory professionals who have a keen interest in IDMP to an information-sharing session. The discussion was “safe” – informal and open to all views and opinions. For me the clear takeaway is the “waiting” to get started on IDMP – for a variety of well-documented reasons – that is taking place across many of the pharmaceutical companies represented. For example, the biggest “wait” is for the agency guidance. Draft guidance was promised almost 2 years ago, and still hasn’t been delivered. Final guidance is expected the second quarter of 2017 with just 18 months after that to submit every authorized product. Yet the same teams that are waiting recognize the fact that time is of the essence, and the longer they wait, the more difficult the task they face.
When we peeled back the onion a bit, clarity around the root cause of the delays in getting started became clearer: It was “we don’t know how to get started.” What seems like a simple problem to overcome was actually very complex and involved a tapestry of stakeholders, organizations, technologies, governance, data and a lot more. The challenge was clear, but the solution seemed out of reach for a very high percentage of those in the room.
Complicating matters were the organizational and technical challenges specific to each company. Many of the comments were prefaced by “Well it’s different for us at ABC company because we have….,” followed by business issues, data issues, technology shortcomings or matrix organizational challenges that would all need to be addressed for a successful IDMP solution to be put in place. So how can this be addressed in the real world, without a one-size-fits-all solution – aka a hammer looking for a nail?
A Transformational Development
With input from our (literally) hundreds of regulatory clients, CSC has developed a way for our clients to get started on the journey: an IDMP Workshop to specifically address the client specific issues that need to be identified and addressed for a successful implementation. One of our “giveaways” at the conference was a 50% off IDMP Workshop. It was very well received by attendees and was highly sought after. A decision was made to draw three winners instead of one based on the interactions with our clients and their desire to frame their own specific blueprint to a solution.
We understand not only what’s required to get an IDMP project off the ground, but how transformational IDMP really is and what each organization has to do – collectively – to arrive at the starting point (the issue of guidelines) fully prepared and devoid of stage fright.
We understand that’s not going to be an easy task because it requires thinking and acting differently. From the outset, executive sponsorship is a critical success factor. There also needs to be business alignment and a solid technology foundation in place – such as a master data management strategy and governance program. You may well need to change business processes, and you certainly need an overall IDMP governance program to keep the program in compliance and adding value beyond compliance to your organization. Stakeholders need to be engaged and involved: Your CIO function needs to understand IDMP requirements and be ready to respond to the changes and the timing involved. A communication program should be put in place to inform multiple internal constituencies why they are being required to change and get people engaged in the problem and driving to a cost-effective, sustainable resolution.
There will never be a one-size-fits-all solution for IDMP. It needs to be adapted to the organization’s processes, products and systems. From our point of view, we work across the CSC enterprise with our data and analytics offerings, business process services, our regulatory experts, our thought leaders who are instrumental in developing and explaining industry standards, our master data management and technology experts, as well as our many partners to help with areas such as data massaging and looking for the massive amounts of unstructured data that will be also be integral to IDMP.
With the right preparation via partnering with CSC you can be ready to perform at your best when the lights go on and the curtains open on IDMP. To learn more about IDMP compliance and managing the data required, join our Town Hall meeting with partner ArisGlobal on April 5, 2016.