Clinical trials are experiments or observations done in clinical research, ensures product safety and effectiveness of biotechnology and pharmaceutical product.
A clinical trial involves various activities like Site selection, recruitment of volunteers/patients, capture consents, research plans and trials maintain participants contact information, tracking deadlines and milestones, electronically store data and documents. By effectively controlling and coordinating critical documentation involved in Clinical Trials, Life sciences companies can increase efficiencies and cut down costs at every phase of their clinical trials.
Challenge:
- Clinical Trials are highly regulated, meeting compliance regulations is challenging, for example, Federal Sunshine Act Reporting.
- Coordination between different sites, vendors and partners is difficult without an effective Clinical Trial Management System (CTMS)
- Half of the cost of a Clinical Trial is spent on monitoring the Sites and collecting data & reports.
- In the majority of cases, Inspection is delayed due to the unavailability of real-time data in the Trial Master File (TMF)
Solution:
- Pharma / Bio-Medical / Life Science companies can build custom clinical trial management software in Officexlr Platform for successful clinical drug trials.
- With Officexlr one can build a web-app hosted on the cloud, so it enables you to manage multiple sites on a single platform, and collect real-time data from various sites.
- With secure document management, you can record and capture all the sensitive data for patient recruitment, consents, health records Lab results and imaging, financials, Real-time Trial Master File in one platform, This will help you get reports and fetch required data instantly.
- You can manage granular access control where you can control role-based access for different sites, regions, and programs.
Benefits:
- Minimize the risk of delays.
- Reduced execution cost and time.
- Improve productivity and research efficiency.
- Cut down approval delays.
- Streamline data and generate reports instantly.
