CHENNAI: Oracle India Pvt Ltd has announced that D&O Clinical Research Organization, a player in the emerging market of clinical data management in India, has successfully implemented Oracle Clinical.
The clinical trial phase is the most complex part of the life sciences product cycle — and in order to reduce time to market, it is critical that companies shorten it. Tracking adverse events and eliminating redundancy in the process of remote data capture are challenges that players in this space have to meet. Companies are also faced with strict regulatory requirements that require detailed records and the efficient handling of huge volumes of data.
Oracle India helped D&O use Oracle Clinical, a part of Oracle E-Business Suite, to meet these requirements. As a result, D&O has been able to compress the cycle for clinical data compilation and open up a new area of business.
Speaking on this occasion, D&O Clinical Research Organization CEO Girish Virkar said, “Oracle has ensured that the clinical data management software is fully compliant with 21CRF Part11 guidelines. This is essential to ensure that the data captured in the database is thoroughly auditable. Oracle Clinical maintains audit trail of the entire sequence of events in clinical data management and ensures that the study can be reconstructed with the log of activities. Second, it provides timely service support. This is very critical when a project requires any technical support; the vendor should be available to solve the problems immediately. These benefits made us choose Oracle over other vendors.”
acle Clinical is a clinical data management solution which allows companies to standardize and control data definitions and data usage across a global operation, ensuring that data is defined, managed, and interpreted consistently worldwide. This expedites the multinational regulatory approval process and reduces cycle times in critical clinical trial processes, thereby accelerating time to market for new products,” added Oracle India sales GM Ram Varanasi.