We know that people are talking a lot about IDMP but at Chaucer we have looked at how we can apply our experience in serialisation, MDM, ETL processes, visualisation and Regulatory Information Management.
IDMP for us starts with a simple conversation to help support your tactical or strategic direction. There is no better time than now to start the discussion as you will want to align existing initiatives (e.g. implementation of R&D CDISC Disclosure standards) so you do not have to make changes down the road.
We look at the challenge of IDMP as a data problem.
Some of our consultants have led projects across large Pharma Organisations (R&D, Operations, CMC) from an IT and business perspective to support the creation, storage and retrieval of data.
We have the knowledge of the IDMP standards and can educate, consult and build a roadmap, but we are looking to what supporting resources and experience we can utilise across a number of geographies and to tie it up with project management methodologies that have been proven through our clients in other industries.
As a consequence of extraordinary preparation and deep understanding you’ve helped us through an MHRA PV inspection with no major or critical findings. As importantly, you left behind a real understanding of how to prepare for inspections in future.VP Global PV and Drug Safety, Tier 2 Pharma Company