All-in-one centralized data management solution
Digital management of clinical trials increases the general performance of a project’s progress and reduces overall error. Clinical.net services developed by OPIS have been designed to streamline the execution of each project while safeguarding the validity and accuracy of each action taken by every study player.
Clinical.net is a highly-customizable modular framework completely developed and supported by the ICT Department in OPIS and is able to collect, integrate, and report all clinical data. Each Clinical.net module can operate as a standalone service or can be integrated into the Study Portal to cooperate with all the other modules through a single access point.
The main modules available into Clinical.net are:
- Electronic Case Report Forms (eCRFs) in different languages and Clinical Data Management
- Study Drug supply management
- Serious Adverse Event (SAE) data collection and notification
- Electronic Patient Reported Outcomes (ePROs)
- Electronic Trial Master File (eTMF)
- Integrated IVRS and IWRS procedure for centralized randomization
- Embedded medical imaging capabilities (eImaging)
- Electronic Learning platform (eLearning)
- Protocol deviation assessment
- Online medical terms coding (MedDRA and WHO)
- Compassionate Use Programs management
- Data import from external sources
- Real-time reporting
From project design to database lock, the proprietary software enables proactive study start-up management, direct electronic entry, information retrieval, and data analysis thus ensuring complete transparency across a project’s lifecycle.
To enhance security and compatibility, the Study Portal can be accessed without additional software or plug-ins and supports a variety of web browsers including Firefox, Chrome, Safari, and Internet Explorer.
The system has been validated in compliance with the regulatory requirements of FDA 21 CFR Part 11 regarding aspects of safety, traceability, availability and data integrity.