As the softwares are becoming the backbone of clinical trials, the costs of softwares supporting the functioning of clinical trials is also rising. In such a scenario the future of open source softwares look promising. Cost-effectiveness, regulatory compliance, feature-sets, easy installation and easy training are few of the features which makes open source an alternative for clinical research. Let us discuss these is detail…
Since, cost is a major factor for most of the start ups and mid-sized CRO/pharmaceuticals, the option of open source softwares is becoming reasonable. With EDC and trial management systems like OpenClinica, TrialDB, OpenCDMS, PhOSCo, FIREBIRD, ASTER, etc. erupting, setting up of data management function is becoming easier. Due to infrastructure investment issues many of the small scale CROs tend to outsource data management activities to third parties. However, with open source softwares coming into picture investments have become negligible. Thus, allowing capturing, cleaning, extracting, and storing trial data achievable by the individual CRO. This addresses most of the challenges faced by the developing countries due to limited basic information systems infrastructure. What we need is computer, Internet connection and people who can operate them, that’s it!!!!
With improving technology taking up the show, the challenges to ensure that the data collected, stored and analyzed electronically are in compliance to the regulations have increased. Hence, most of the open source systems are designed in compliance to globally used guidelines like Title 21CFR Part 11, HIPPA, etc. This ensures that the data captured, stored and analyzed are in compliance to the global regulations.
Most of the open source softwares are designed to support all types of clinical studies in diverse research settings making them flexible for variety of trials. Some systems like OpenClinica, PhOSCo, TrialDB and OpenCDMS provide solution right from Management of numerous/diverse clinical studies – Data submission/validation/annotation – Data filtering and extraction – Study oversight, auditing, and reporting. While some software like FIREBIRD and ASTER provide solutions for specific domains i.e. FIREBIRD provides investigator registry while ASTER provides solutions for Adverse Event Reporting.
Easy Set up and Training
Open source softwares allow easy set up of the system as the software is freely downloadable. The instructions for set-up and installation are easily available on-line. This makes set up on the whole, an easy process. The free demos for the systems are available on-line, allowing anyone and everyone to understand operations easily and undergo self training without anyone’s help. This makes the training part easy as well.
“All these above characteristics provide alternatives for clinical research industry but how willing is our industry to try this out. The willingness of the companies will come when more and more vendors approach with their software options to the companies, when the consultancy firms will come up with these ideas which would lower the budget significantly. More awareness and willingness is the need of the time.”
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