When one considers a Meta-Data Repository (MDR) implementation in the Pharma Industry today, one tends to focus immediately on the technology.
‘Which technology is the right one for my MDR implementation?’ – is one of the first questions that comes to mind. This, together with an unfounded expectation that MDR technology providers may have a ‘ right solution’ for my MDR needs are one of the top reasons why the MDR implementations fail.
Another trap, that one tends to fall in, is the notion that ‘we need a new and innovative solution that requires us to redefine all of the standards and meta-data that we use today’. Even if one gets an agreement in the organization to undertake such a transformation, one is quickly brought to a standstill simply by the enormousness of the task. The transformation teams are simply paralyzed by the sheer size of the content that needs to be transformed according to new ideas and models.
Instead, one should ask ‘What is the right road-map for my MDR transformation?’. The answer to that question will provide a path to one’s MDR implementation or transformation that enables:
- Timely and value focused MDR implementation
- Fast value and benefit derivation
- Cost and risk spread and reduction
- It is important to understand that such an approach is technology-independent. Depending on your company situation, the technology that would provide the best support to your business processes may vary, but the road-map, objectives and benefits remain.
At intilaris, we specialize in providing the consultancy services for transformation of an existing MDR and Standards Management into a more effective MDR management supported by an appropriate technology solution. We have the industrial experience with top tier Pharma to assess your current MDR/Standards Management situation and provide a clear roadmap to transform it into the modern and powerful innovative solution – effectively into a ‘Smart MDR’. Our end roadmap goal of the ‘Smart MDR’ will among other benefits enable:
- Definition of the standardized high-level business objects for Clinical development (Protocol Standards, eCRF, etc.)
- Clinical Development End-to-End process support
- Standards traceability
- Instant impact analysis for all changes
- Submission support (Define.xml, Value Level Metadata, etc.)
- Automation of study metadata setup (Selection of Protocol Activities define the full set of study metadata)
