You could argue that anything done in a new way, however small, can be counted as an innovation. Introducing innovation at a game-changing level, however, is not so simple, and it's only going to get harder for the pharmaceutical industry.
Blog
Where our team of guest writers discuss what they think about the current NGP US Issues.
Director of Business Development
Can digital pathology save drug development?
Peter Duncan of Definiens discusses the potential of digital pathology.07 Jul 2010
Posted: 18 October 2009 @ 14:59
Claim from EDC vendors that their technology is not performing up to advertised parameters because clients do not follow processes does not make much sense. Processes are so complex and complicated that they cannot be reasonably followed.
Posted: 18 October 2009 @ 15:05
Intelligent DM Model
IDC / M
Intelligent Data Capture / Management
Rethinking the DM Operation?
EDC currently available on the market have all a few feature in common.
Hi level of integration, complicated processes, difficult to operate, can take care of the quality of clinical data only at prohibitively high costs.
A few examples to illustrate:
In a recent bid defense for a multimillion dollar contract, Bayer expressed doubt that a Query based EDC can deliver the quality clinical data they are expecting.
A major CRO working a query based EDC study for a pharma client is facing strong dissatisfaction from the client over the quality of the clinical database.
Halfway through the study there are about 53,000 queries. At industry average of $100 per query resolution the cost for query resolution alone is around $5.3 million. Adding the costs of manual reviews needed to complete database cleaning the overall cost of cleaning a database goes easily to $10 million.
Needless to say, typical data management budgets for these types of studies is only a fraction of the $10 million cost.
How do data management operations cope with these budget – cost discrepancies? They don’t cope. The quality of the clinical database is either not there or the prohibitive cost of cleaning the database gets shifted from data management to other services provided like clinical, medical or statistics.
Recently, in a head to head quote from a major CRO for a phase I study
– Query based data management quote was $80,000
– Intelligence based data management quote for the same study was $5,000
Intelligence data management (IDC) delivered on time and on budget and a 12% profit, a 0.08% error rate database well within all requirements of a FDA submission.
Claims from EDC vendors that their technology is not performing up to advertized paramenters because clients do not follow processes makes no sense. Processes are so complex and complicated that they cannot be...