Clinical Trials Management Systems (CTMS): It is the most widely used trial management system that is catering to global top pharmaceutical companies and CROs to perform their clinical trials. The technology is based on Oracle Clinical.

Electronic/Remote Data Capture (RDC / EDC): ICBio has the OC RDC 4.6, which is Oracle’s next-generation electronic data capture application. RDC Onsite helps sponsors and contract research organizations (CROs) launch and conduct studies efficiently and effectively even within this regulated and complex industry.
RDC Onsite empowers site personnel with unsurpassed functionality leading to improved database lock times for sponsor organizations. This enables clinical study sponsors and their service providers to streamline the clinical data management process right from collection to cleaning, and analysis of the clinical data.

Thesaurus Management System (TMS): One of the most time-consuming tasks within the drug development process is classifying verbatim terms to permit deriving standard medical and drug terms for use in analysis from the free text originally captured. Oracle TMS streamlines this critical and costly task by providing a centralized, globally available repository of dictionary terms and associated verbatim terms.

Oracle Thesaurus Management System (TMS) addresses the complexities associated with managing global thesauri. Designed to manage and classify free text captured during the drug development process, TMS meets the needs of multinational pharmaceutical, biotechnical, and medical device companies, contract research organizations, academic institutions, and regulatory authorities by providing a worldwide, scalable terminology repository. Within the Oracle life sciences application suite, TMS provides terminology services for Oracle Clinical, Oracle Remote Data Capture, Oracle Adverse Event Reporting System, and Oracle Life Sciences Data Hub.

Information in the repository is accessible through advanced searching and classification algorithms. TMS supports all dictionaries required by international regulatory authorities. Additionally, TMS can support and integrate with company/organization-specific dictionaries and legacy applications like MedDRA, MedDRAJ, MedDRA SMQs, SNOMED, ICD9, WHO-ART, and WHO-Drug with a number of hierarchy levels and multiple versions of the same dictionary.

Paper Based Studies: Oracle Clinical Soft ware facilitating effective data capture (Data entry) and management along with CDMS. Further security of the transcribed data per 21 CFR Part11 secures and maintains the confidentiality of data effectively.

Oracle has built the most comprehensive suite of applications for clinical development. The products, Oracle Clinical, Oracle Thesaurus Management System, Oracle Adverse Event Reporting System, Oracle Life Sciences Data Hub, can be deployed individually or together allowing for incremental growth for existing customers or a full eClinical suite for new customers. All the applications have been designed with integration in mind to:

Oracle Clinical Adverse Event Reporting System (AERS): Oracle Adverse Event Reporting System (AERS) gives pharmaceutical companies the power to store and monitor all serious adverse events so that safety concerns can be addressed before a drug reaches the market. Oracle AERS is also the only safety system that is fully integrated with the leading clinical data management System – Oracle Clinical.