Thursday, 29 September 2011

Clinical Trial Data Management

Clinical data management includes the entry, verification, validation and quality control of data gathered during the conduct of a clinical trial. Standard Operating Procedures explain the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines in the conduct of data management activities. A clinical data management system is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data collected at the investigator site in the case report form (CRF) are stored in the CDMS. To decrease the possibility of errors due to human entry, the systems employ different means to confirm the data.
The present day Life sciences industry demands flexible solutions to accelerate the drug development process on one hand while reducing costs of the clinical development process on the other. The most companies followed by this Clinical Data Management Services such as,

Clinical Data Management Services
  • Case Report Form (CRF) design
  • Database design and study arrange
  • Data entry and verification from multiple sources as well as paper, EDC,
  • Online data validation
  • Medical coding with MedDRA and other dictionaries
  • Medical Catalog
  • Protocol-wide database integration including legacy data, and standardization with new coding dictionaries
Bio Statistical Services
  • Statistical analysis plan design
  • Sample size calculations
  • Randomization schedule design
  • Interim analysis
  • Exploratory analysis and statistical modeling for efficacy and safety evaluation of drugs
  • Statistical support for publications and post marketing analysis
  • Integrated analysis of efficacy and safety
SAS Services
  • Creation of analysis database
  • Edit checks and database clean-up
  • Program synopsis tables, listings and graphs


Case Report Form Design:

Case Report Form (CRF) is the data collection tool for the clinical trial and can be paper or electronic. Paper CRFs will be printed, often using No Carbon Required paper, and shipped to the investigative sites conducting the clinical trial for completion after which they are couriered back to Data Management.
Electronic CRFs let data to be typed straight into fields using a computer and transmitted electronically to Data Management. Design of CRFs wants to get into account the information necessary to be gathered by the clinical trial protocol and intended to be included in statistical analysis. Where available, standard CRF pages are may be re-used for collection of data which is common across most clinical trials.

Database Design:

For clinical trial utilizing an Electronic Case Report Form the database design and make and CRF design are closely connected. The electronic CRF will allow entry of data into an underlying relational database.

For clinical trial utilizing a paper CRF the relational database will be built separately. In both cases the relational database will allow entry of all data captured on the CRF.

Data Entry:

When an electronic CRF is in use data entry is carried out at the investigative site where the clinical trial is guided by site staff that have been granted appropriate access to do so.

When using a paper CRF the pages are entered by data entry operators. Best practice is for a first pass data entry to be completed followed by a second pass or verification step by an independent operator. Any discrepancies between the first and second pass may be resolved such that the data entered is a true reflection of that recorded on the CRF. Where the operator is unable to read the entry the clinical data manager should be notified so that the entry may be clarified with the person who completed the CRF.

Data Validation:

Data validation is the application of validation rules to the data. For electronic CRFs the validation rules may be utilized in real time at the point of entry. Offline validation may still be required.

This whole process utilized for Clinical Data Management process. Now I just find out the one concern provide from this overall above process. They provide a good and efficient Clinical Data Management Services across the globe. I mention the contact details:

1 comment:

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