Technology and its role in improving clinical trial processes
06 Mar 2018
Clinical trials are long, complex and expensive processes, and electronic data capture (EDC) offers many benefits to resolve some of these challenges. Nowadays, clinical research industries are moving fast towards the EDC system to accelerate clinical trial processes so as to increase data quality, regulatory compliance and cost reduction.
EDC system is used to plan, acquire, access, exchange and archive data required for the conduct, management, analysis and reporting of the trial.
Use of EDC system in clinical studies helps to increase data accuracy and efficiency which will provide quick and easy access to clean data, while ensuring quicker product development.
Right from the beginning of the study, designing case report form (CRF), online edit-checks implementation, and annotation of the CRF (aCRF) becomes easier through EDC. By this system, processes involved in data entry, data validation, and query management have also improved significantly. With ‘Click & Go’ functionality, queries and edit-check resolutions in EDC trials become very fast. The entire query management process can be handled within the eCRF portal.
With available data, the EDC provides various reports automatically, which are supportive and helpful to plan subsequent tasks during the course of the trial.
Now, let’s take a look at some of the advantages of the different functions in the EDC system.
| Function | Advantages |
| User support | · Online training |
| Access rights | · Limited access and required rights as per role |
| Data Security | · Protection against data manipulation |
| Validation | · Implement checks and range to minimize the entry error |
| Audit trail | · Record all data changes in the system and can be reproducible |
| Data storage | · Archive and store the data for longer duration |
The quick adaptation of such technology by the clinical trial industry helps to accelerate the overall process of the drug development, and ultimately helps to introduce new treatment in the market much faster. Clearly, there are remarkable benefits in identifying how these new technologies can positively impact clinical trials.