Oracle Clinical aka OC is a comprehensive clinical data management platform from Oracle Corporation. The total clinical platform includes trial management, Remote Data Capture (RDC), CDM, adverse event tracking system and thesaurus.
The Oracle Clinical software is divided into sub-systems, and each sub-system is focused on a core functionality such as administration, lab, study design, definition, data extract and planning. The key advantage with OC is the compliance with 21 CFR part 11. Most of the sales pitch from Oracle is based on the powerful validation support, but we found it non-trivial for people without PL/SQL knowledge to work with the code. The bulk data load is also a great advantage, and this is missing in more basic applications like OpenClinica.
On the market share side OC has a strong presence in North America and has lesser share compared to Phase Forward's Clintrial in Europe.
Establishing a data center with OC needs a 100% overhead on validation and compliance of the system where OC will be installed. The software license cost is somewhere between 75-100 k$, and Oracle will be happy to make another 100k$ on SOP, installation and other support activities.
In India some IT majors such as InfoSys have OC installed, but it will take some effort to establish a level of confidence among overseas clients to use offshore OC installations and data centers, and this is feasible for larger companies with brand and track record in other areas like banking etc.,
Clinnovo is currently looking for partners in US to establish a data center and the discussions with a NJ based company are in advanced stage of discussion. We hope to leverage from the US presence of our data center.
The Oracle Clinical software is divided into sub-systems, and each sub-system is focused on a core functionality such as administration, lab, study design, definition, data extract and planning. The key advantage with OC is the compliance with 21 CFR part 11. Most of the sales pitch from Oracle is based on the powerful validation support, but we found it non-trivial for people without PL/SQL knowledge to work with the code. The bulk data load is also a great advantage, and this is missing in more basic applications like OpenClinica.
On the market share side OC has a strong presence in North America and has lesser share compared to Phase Forward's Clintrial in Europe.
Establishing a data center with OC needs a 100% overhead on validation and compliance of the system where OC will be installed. The software license cost is somewhere between 75-100 k$, and Oracle will be happy to make another 100k$ on SOP, installation and other support activities.
In India some IT majors such as InfoSys have OC installed, but it will take some effort to establish a level of confidence among overseas clients to use offshore OC installations and data centers, and this is feasible for larger companies with brand and track record in other areas like banking etc.,
Clinnovo is currently looking for partners in US to establish a data center and the discussions with a NJ based company are in advanced stage of discussion. We hope to leverage from the US presence of our data center.
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