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Does Pharma still need a CTMS?
17th July 2014
Tammy Finnigan, COO Triumph
In a world of outsourcing and strategic partnerships where does a CTMS really fit between the Sponsor and the CRO?
About 4 years ago Triumph observed a gradual decline in the number of new CTMS implementations, as most of the large to mid-sized CROs and Pharma had completed their implementation roadmaps. Market demand has moved us towards helping companies make their clinical trial processes more efficient and effective, and putting data models in place that fit and support their operating model. During the past 2-3year we have observed the shift from insourced trial management towards a globally outsourced model with strategic CRO partners. A number of our pharma clients in this area, are using Triumpg to re-model the data flow to support this change in operating model and for many of those clients, it has lead to an important question: "What is the strategic ‘fit’ of CTMS in our new operating model?" So taking that one logical step further, this leads me to question, in this global outsourced model, is there still a need for a CTMS?
When you look at it on the surface, the obvious answer is no, right? In strong partnership models, pharma may be using sponsor portals to manage the oversight responsibility, or if there is a desire to ‘own’ the operational data, there may be clinical and operational data hubs/warehouses, with a well-defined data model and the partners are providing the data. In either of these models, what purpose does the CTMS serve?
As we have performed the analysis phase for a number of projects we have found that the answer to the ‘do we need a CTMS?’ question is not a simple ‘Yes/No’ … On 2 recent projects I observed that the client already had an answer to this question in mind before the kick off… One was very much ‘Yes, but we’re not sure why…’ The other was driving towards ‘No! We don’t need it because …’ As we worked through the initial analysis, it became increasingly clear that CTMS does perform some integral functions in the clinical trial process, even in the outsourced models … and what we are seeing is a change in the scope of CTMS, shall we say, ‘CTMS-lite’, but just how ‘lite’ which is very much determined by the company’s maturity in some of the core business operation processes.
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