Clinical Data Management

CDM services with maximum flexibility. Sponsors may contract all or a portion of their CDM work load to Oricent. Our infrastructure and clearly defined system interfaces provide us the flexibility to define work processes between a sponsor system and our environment as well as seamless integration in to sponsor defined processes. Our systems & services are based on industry recognized standards and technology platforms to ensure that even the most challenging data management activities are efficiently and effectively addressed. 

Oricent Life Sciences offers a complete range of clinical data management activities using one of the most powerful clinical data management systems: Oracle Clinical (O.C) 

With over the years of system and user experience, our current data management version OC 4.5.3 is fully validated and 21 CFR Part 11 compliant. The following tasks are performed by Oricent using Oracle Clinical: Randomization, Database set-up, 

Data entry, Medical coding (the Oracle TMS (Thesaurus Management System) version 4.5 is used for coding medical information initially entered in Oracle Clinical as verbatim terms. Different versions of dictionaries can be used to fulfill the sponsor's needs.

Coding specialists perform the coding in the standard and proprietary coding dictionaries MedDRA and WHODD), Discrepancy handling, Laboratory data handling and Data extract.

Oricent Differentiators in Clinical Data Management:

  1. Qualified Database Programmers experienced in designing and implementing Clinical trial databases and data validation programs.
  2. Coding specialists to assist coding in standard and proprietary coding dictionaries such as MedDRA, WHODD, and ICD-9-CM.
  3. Specialists experienced in drafting CRFs and questionnaires.
  4. Trained and experienced data entry specialists
  5. A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ different means to verify the data.
  6. Classification
  7. The CDMS can be broadly divided into Paper based and electronic data capturing system.
  8. Paper Based Systems
  9. Case report forms are manually filled at site and mailed to the company for which trial is being performed. The data on forms is transferred to the CDMS tool through data entry. The most popular method being double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by the system. In case the entry of a value conflicts, system alerts and verification can be done manually. Another method is Single Data Entry.
  10. The Data in CDMS is then transferred for the data validation. Also, in these systems during validation the data clarification from sites are done through paper forms which are printed with the issue description and sent to the investigator site and site responds by answering on forms and mailing it back.
  11. Electronic Data Capturing System
  12. In such CDMS the investigators directly uploads the data on CDMS and the data can then be viewed by the data validation staff. Once the data is uploaded by site, data validation team can send the electronic alerts to sites if there is any issue.
  13. Such system nullifies the paper usage in Clinical trials validation of data.
  14. Clinical Data Management
  15. Once the data has been screened for typographical errors, the data can be validated to check for logical errors. An example is a check of the subject's age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there is an error in the data or clarification from the investigator is required.
  16. Another function that the CDMS can perform is the coding of data. Currently, the coding is generally centered on two areas; adverse event terms and medication names. With the variance on the number of references that can be made for adverse event Terms or medication names, standard dictionaries of these terms can be loaded into the CDMS. The data items containing the adverse event terms or medication names can be linked to one of these dictionaries. The system can check the data in the CDMS and compare it to the dictionaries. Items that do not match can be flagged for further checking. Some systems allow for the storage of synonyms to allow the system to match common abbreviations and map them to the correct term. As an example, ASA could be mapped to Aspirin, a common notation. Popular adverse event dictionaries are MedDRA and WHOART and popular Medication dictionaries are COSTART and WHO Drug Dictionary.
  17. At the end of the clinical trial the dataset in the CDMS is extracted and provided to statisticians for further analysis. The analyzed data is compiled into clinical study report and sent to the regulatory authorities for approval.