One of the biggest challenges in global multi-center clinical trials (after enrollment of patients) is collaboration between multi-center clinical trial teams: CRAs, investigators, regulatory, marketing, manufacturing, market research, data managers, statisticians and site administrators.
In a complex global environment, pharma do not have control of computer platforms that local sites use – yet there is an expectation that file and information sharing should be easy yet there are three areas where current systems break down:
1. People forget what files had been shared and with whom they have been shared
2. People have difficulty sharing files with colleagues in a way that is accessible to everyone – firewalls, VPNs, enterprise content management, DRM, corporate data security policy, end point security, file size – these are all daunting challenges when all you want to do is share a file with a colleague in Berlin when you are working in a hospital in Washington.
3. Notifications – how do you know when new information has been added or updated? Not having timely notifications on updates can be a big source of frustration resulting in team members pinging other members over and over again with emails.
Over the past 10 years a generation of complex enterprise content management software systems have grown up – they are bloated, expensive, difficult to implement, not available to the entire multi-center team and in many cases written by English speaking software vendors who cannot conceive that there are people in the world who feel more comfortable communicating in their native tongue of French, German, Hebrew or Finnish!
We are developing (currently in beta with a Tier 1 bio-pharma in EMEA) a Web-based, agile collaboration system with a light-weight, easy to use, simple architecture, that saves time and reduces IT and travel costs – and literally gets everyone on the same page.
The system resolves the 3 breakdowns above while recording all user activities in a detailed audit trail in order to meet internal control and FDA regulatory requirements.
The system also provides significant cost benefits in addition to improving information collaboration:
• Reduces travel costs: Using online events, integrated media and file sharing and discussions, the clinical trial team and investigators can conduct program reviews, education activities and special events.
• Eliminates proprietary IT: No proprietary software or hardware and no IT integration. No extra investments in information technologies, CRM, sales force integration and data mining.
If this interests you – drop me a line!