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…
Cost-Effectiveness
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!!!!
Regulatory Compliance
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.
Feature-Sets
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.”
Related Links:
Is Biopharma ready for open source software?
Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?
Very nice article. I hope that Pharma players become more willing to look outside the Box that’s made up of Oracle, SAS , SAP and the like. We at Plus91 have developed Trial Management and Analysis Software which is helping manage 8 trials as of today, and it took us a long time to convince the related labs to give us the break.
Even though the price is lower and the features significantly more, there seems to be lots of resistance to change. For creating awareness, we should be looking at improving the relationship between IT and Pharma.
Besides conforming to standards such as 21CFR Part 11, which basically does’nt say much, its important that IT adds layers of security over and above these standards to maintain sponsor satisfaction.
Further, Open Source Trial packages should have features such as Budget enhancers which will improve their usefulness to both the CRO’s and sponsors. Most of all, the usability aspect should really be worked on. Most of the software’s mentioned above can really be redesigned with much simpler UI’s. The present one’s have a learning curve which can be worked on …
All said and done..its important that Open Source products in this segment start looking beyond simply data management and actually start carrying out complete process management.
WOW!!! …the formatting in the comment above went for a toss… Shruti, if you could either let me edit it or edit it yourself, I’d be grateful. Thanks…
Hi Nrip,
Thanks for your comments. Its nice to know that you are working on the same lines. I hope in near future we will definitely be able to create willingness among pharma’s and CRO’s to accept the new technology. I guess one of the important thing that marketed product do is marketing of their product. So we will also have to do that initially to create awareness.
Also User Interface will improve with more and more people coming to use it. After all users can define User Interface much better than anyone else….
Nirp, you very rightly said that “Open Source products in this segment start looking beyond simply data management and actually start carrying out complete process management.” We hope to see this in near future. After all its “Tech Age”…
And yes, you can have a look at your comment… Formatting is in place.
Thanks and Regards,
Shruti.
Thank you for a great article! Somehow my past experience with OPenSource software has been it takes more time for training and implementation. Maybe that has changed now?
Thanks for this wonderful article to increase the awareness about the alternatives to legacy systems!
If you could suggest one of the many opensource clinical data management softwares you mentioned..which one would it be?
Regards
Dr. Manish