Part II: Four Technology Approaches for IDMP Data Management

Welcome to Part 2 of my ‘IDMP Technology Approaches’ blog.  The story so far is that I have seen four major technology approaches to achieving IDMP compliance:  Manual, Data Warehousing, MDM (my favourite) and RIMS.  In Part 1 of this blog I covered off the Manual and Data Warehousing approaches.  From my viewpoint what these two approaches have in common is they have limited data governance capabilities.

One of the best IDMP insights I heard in 2015 was from Dr. Jörg Stüben of Boehringer Ingelheim[i]:  In order to comply with IDMP, you have to be in control of your data.   Unfortunately many pharmaceutical companies are not in control of their data.  Product data tends to be managed on a departmental level, in multiple different systems.  By including data governance processes in the IDMP business processes, pharmaceutical companies should be able to both reduce the overall effort of compliance, and deliver value across the organization beyond IDMP.  The approaches discussed below have more advanced data governance capabilities than the two approaches discussed in Part 1.

Technology Option 3:   Using an MDM Approach

 

mdm
IDMP: Option 3, Using an MDM Approach

 

Why choose this technology:  MDM as a technology is specifically designed to automate how master data is consolidated, resolved and managed in order to create trusted data.  It is a mature and proven technology with advanced features for complex data models, automation of data record consolidation, attribute resolution, process flow and complete data lineage tracking.

Data Quality technology is an excellent complement to MDM, increasing processing efficiency and data accuracy.  Submission can be achieved either through a RIMS system, or data exchange technology such as B2B Exchange, which is specifically designed to manage the interchange of data between two organisations.

The key differentiator for the MDM approach is it enables use of the IDMP data set in other areas of the business to extend the solution’s value beyond the single area of IDMP compliance.   MDM supported by data governance process will improve your organisations’ overall product data quality, which is becoming increasingly important for competitive advantage.  The phased approach to MDM provides a real opportunity to strengthen data governance processes as part of the IDMP compliance program.

Challenges:  It is not advisable to separate MDM technology from MDM processes, meaning that a choice for MDM is a choice for improving data governance.  This is only a challenge if you do not have the senior level sponsorship to embark on an MDM or data governance program.

Technology Option 4:  RIMS vendor supplies the entire stack

 

mdm
IDMP: Option 4, RIMS vendor supplies the entire stack

 

Why choose this technology:  For companies with a strong relationship with a RIMS vendor, the benefits of relying on that vendor to provide both the data integration and data submission layer is compelling.  If not provided by your RIMS vendor, a rules-based Data Quality technology should be considered in conjunction with your RIMS solution.

A standard RIMS IDMP solution may not come pre-packaged with all the data transformations you need from your internal systems into the IDMP data model and controlled vocabularies.  Data Quality can capture, manage and re-use these numerous rules in addition to other features to pro-actively improve data quality.

Challenges:  My main concern with this approach is that I see RIMS as a one-way road for data.  Data is collected and funneled towards the regulators, but with limited opportunities to re-use the rich IDMP product data set to gain competitive advantage outside of regulatory affairs.  Similarly data governance capabilities may be limited to the processes which are executed within the RIMS system and not offer a broader increase of data governance maturity across the organization.  This will be a huge missed opportunity.

A compelling RIMS optionParexel Liquent and Informatica have come up with an excellent solution to this challenge.   Liquent’s IDMP solution incorporates Informatica’s MDM technology, providing the best of both worlds:  A submission tool which is specifically designed for the complete IDMP process, seamlessly integrated into a fully functional multi-domain MDM system.  Use of the underlying MDM system can be extended beyond the scope of IDMP submission as your IDMP and data governance programs mature.  The Parexel MDM approach will most likely be popular with those IDMP teams who want all the benefits of the MDM approach, but would like to demonstrate the value of MDM internally before securing a direct investment in MDM.

Summary

There will probably be many different architectures implemented to achieve IDMP compliance – almost as many as there are pharmaceutical companies in the world perhaps.  However, every solution will have some common elements in order to achieve a common goal:  Supporting well managed IDMP business processes to continuously consolidate and submit a broad set of auditable high quality product data.

Informatica is already a well-respected provider within the Pharmaceutical sector of many of the common elements required to achieve this:

  • Data Integration
  • Data Quality
  • Master Data Management
  • Data Governance

We have the experience and knowledge to help you deliver high quality IDMP data regardless of your chosen IDMP technology stack.  Informatica can ensure that your technology stack matures with you, reusing the data quality and data integration routines even if your ‘Product Data Consolidation Layer’ technology changes as your data maturity increases.

2016 is shaping up to be a very busy year in terms of IDMP compliance.  A year in which technology decisions will be made, and most implementation projects started.  I wish you all a Happy New Year and an IDMP project that is on-time and on-budget.  (And may you choose the IDMP solution that is right for you.)

[i] Dr Stüben’s talk at a Marcus Evans IDMP conference

Comments