EDG & RWD/RWE …

LSCP “Format Free Initiative” (FFI) gets even more traction

A solid EDG Data Strategy starts …

Authors:
Ruedi F. Blattmann (lead), Dr. Beat Widler, LSCP; Prof. Peter Aiken (Strategic Partnership since 2016)

We have to get organized in a different way. Valuable data is extracted from your Digitalization processes. New data sources are being merged with legacy data. The amalgamation of data needs to make good business sense as well as regulatory sense. Regulators like FDA & EMA have recently published their views about what and how they would consider data to be relevant.

Our work and customer awareness of the need to manage data with governance with developing a solid data strategy has progressed that therefore we have included the experience in the document that we recommend to retrieve here:

New document in progress

 

How important are Product Information (ePI/USPI) Assets to you?

Updates and Recommendations:

Again, with the new – uncertain – EMA timelines that have been communicated that strengthen our approach to have a closer, holistic view on IDMP, SPL(R9), ICSR(R3) – we call it collectively IDMP+, Enterprise Data Governance (EDG), driven by the fact of increased content granularity and last but not least to dramatically increase matured discovery in context by applying Semantic Technologies (ST) to make data assets become actionable:

You have (substantially) invested in all 3 ISO IDMP+ areas, so the driver here is recommended to be: Preserve investments, prevent knowledge drain and motivation – bring all into a new focus where everyone that engaged so far can continue to contribute

What about eCTD V4 & RPS in the above context?

As Corporate Data Assets (unstructured [80%]; structured [20%]) drive the business, especially in context of IDMP+ (compliant data, many more opportunities “outside” regulatory affairs), Industry has an ideal momentum to leverage those assets by Managing Data with Corporate Guidance:

No innovation without Information – Time is Right digging deeper for more value!
PI are one so important group of Corporate Data Assets to diligently take care of:
Product, document, creating and maintaining DATA LIFECYCLE …

New document in progress

A Claim from our IDMP+ Leader

Regulatory data deficiencies (i.e., incorrect, improper, missing data) are costly and adversely impacts regulatory decision making thus affecting your authorization to market. A solid solution must be built upon sound data governance principles ensures compliance and strengthens your competitiveness from strategy to execution, allowing you to have command and control of your data.
Vada Perkins, 2017

Impact:
Data lifecycle management, moving from “simple” document level to more sophisticated structured content to enable improved agility

  • Data Models, Data elements and their structure(s) – what elements for use where
  • Content (not document) re-use

Over time: Building a Solid Data Foundation via EDG*

Architecture to enable future steps down to IDMP+ Data Elements and their detailed structure to optimize re-use – for business and regulatory purposes

Addressing the strategic concept: Publish data to any format when time is right

When we think “data”, want to organize them, understand their relationship we recommend to take the latest ISO IDMP/SPL/ICSR (IDMP+) Implementation Guides (IG) as a “benchmark”, representing the compliance part of the data requirements – to drive the business ones!

IDMP Strategy – re-scope: Process output is/must be to provide a strategic, holistic framework for all functions about how data (from a business perspective) will be created – manipulated and managed – stored – search/discover in context and apply (WHY to what target as a business/compliance requirement) – re-plan.

This will allow stakeholders to “free” themselves from technology solutions – re-think the future …

Collectively, we recommend:

Delays in implementation provide an opportunity for Industry to prepare and plan accordingly

Why we propose looking beyond …

Independent of new EMA dates we strongly recommend to use the now

“Extended Regulatory Grace Period”

to organize semantically enriched product data (analyzing IDMP data element structures for re-use) from a global perspective, enterprise wide (EDG) in a way to

  • reach optimal agility, regardless of what and when the forthcoming regulatory data requirements are going to be enforced and,
  • to serve IDMP data consumers (Label, CMC, Market Access) in a most efficient way

Option:

Looking beyond the “Regulatory Plate” – Content Creation, Management, In- & Output

At first, to recognize where data is going to be used (WHY) as well, a holistic view is a pre-requisite. By taking this route a company will avoid costly re-work in many aspects:

From “sectorial” selection for a Proof-of-Value (PoV) to a functional implementation of EDG in context of IDMP+ the Data Architect will have to consider … Use Case (UC) Examples: Where can we identify priorities that create highest value as low hanging fruits?

“Evolution of Search”

There will never be less data than right now –
Quality data (part of EDG) must enable you to make better and data documented decisions!

So the Challenge we face is how find relevant data effectively and in context:

The recommended path is to not just extract data from legacy documents, but to semantically enrich your content and build semantic data models.

Enabling Semantic Technologies (ST) for the Knowledge Space will be – also for those (multi-multi directional, but consistent and transparent) Communication Targets:

  • Indexing and Search of unstructured content
  • – Natural Language Processing and Linguistics
  • – – Text Analytics (to include sentiments from Social Media)
  • – – – Entity Extraction, and ultimately
  • – – – – Fact Extraction,

leading to the description of the progression” … “strings to things” – discovering in context

READ MORE
FULL DOCUMENT

And once you have defined your new holistic PI Framework, you should think of this:

CHANGE MANAGEMENT (CM – SME Kathy Hagen)

The People Part of a Project:

The transition to implementing IDMP+ and EDG requires that everyone involved is aware of, accepts and acts on the change. Without people engagement, the work will achieve limited value.

LSCP has a deep understanding of CM and all of the critical aspects including Communication, Organizational/Cultural Change, Effective/Targeted Training and Leadership Alignment

Our CM process and tools are integrated throughout the project and our communication planning will be integral at every step of the way. We will partner with you to create a Change and Communication Strategy to ensure sustainable success of this crucial work

READ MORE
FULL DOCUMENT

To close,

Our Contribution/Objective

  • We do understand that your company is, as to IDMP already “in full swing”! Is your initiative holistically under way, including SPL & ICSR, referencing the ISO IG?
  • LSCP is probably one of the few Service Providers in this space with a HOLISTIC approach to IDMP+ in conjunction with Enterprise Data Governance (EDG) and the application of Semantic Technologies (ST) – aiming to leverage your current/past investments in the topic or part of it
  • We would like to COMPLEMENT existing initiatives (integrate with current providers – non-disruptive!) and not to replace them!
  • Thanks for considering this message from this perspective

AND …

What is your CONCLUSION here …?

LSCP would like encouraging you to get in touch with us at your earliest convenience:

We suggest to mutually discussing with your IDMP+ Stakeholders and our leading functional SMEs:
Design and potentially execution of a Workshop to elaborate together an optimal, pragmatic approach defining about how to create and manage your data assets in the future. Benefit from the given synergies of the three key and crucial domains outlined above – high level to start with!

Collectively, we thank you for your attention … and action!