e.Smart is a system for capturing data in pharmaceutical and medical device clinical trials
eCrf system – story and evolution
In 1999 Aram started a project with Bayer Italia: the aim is to create a system for data entry of clinical studies.
So Aram developed a powerful engine for CRF clinical data management fully-validated with FDA requirements for collecting clinical trial data.
In a first phase the engine is engineered in client-server technology with a client interface for the eCRF development.
Our customers chose to left eCRF design in our hands saving resources and costs. In 2004 the engine became a “service”: eCRF is designed by Aram.
In 2010 the system, following technology evolution, became fully Web and was named e.Smart web.
In 2010 is born cloud e.Smart platform with centralized services in cloud.
Through our system we have produced about 70 Quality Certified eCRF and just as many without QC in all therapeutic areas and clinical phases. Quality Certified logo is a plus of our eCRF system: by our certification the eCRF is validated following latest rules about clinical data capture.
Our system is “easy to setup”: about two hours and its “Ready to go!”
eCrf system – WHO
Our system is very flexible and can be used for very small studies and for big and complex ones.
Our customers are:
– Clinical Trial Professionals
– Research Centers
– Medical Device Companies
– Pharmaceutical Companies
eCrf system – Features
Our eCrf, system is a high quality web application developed with deep clinical and software expertise. As a web system it is ALWAYS and EVERYWHERE available.
We use these main adjectives to describe e.Smart:
Simple because its interface, simply to use and intuitive, is always the same, for all studies. Personalization, such as sponsor or study logo are possible, for every study. A short and simple training is necessary at first study to understand all the process. After the first trial the interface is well known.
Fast because developed in efficient way using best programming tools. Once login with autentication is the way to access to more centres and patients.
Safe because is the evolution of a system used in more than 15 years, based on experience on the field.
Security is guaranteed by:
- Authenticated access to the system in two different ways:
- Login to the system with user name and password
- QRAuth system access by smartphone.
- FDA 21 CFR part 11 and CGP compatibility
- Different user levels
- Warning and alerts
- Scheduled periodical backup
- Last https certificate security
eCrf system – Architecture
The system is available in two different architectures according to customer’s requirements.
The first architecture is suitable for Customer who wants a complete service and has these features:
- eCRF development
- use of e.Smart Cloud for the system and the services
No need of infrastructure installation.
The second architecture is for Customer who needs the system in his web architecture and has these features:
- eCRF development
- eCRF installation on Customer’s Webserver
- possible use of e.Smart Cloud services
eCrf system – Main functions
e.Smart innovative EDC platform has these functions:
- Users type management
- Users management, access by user and password
- Edit checks
- Ongoing statistics
- Integrated quiz and interviews
- Personalized and punctual reporting
- Query on going
- Auditing on all pages and/or single device information
- Paper CRF Printing
- Vertical archiving of all activities
- Final porting on DVD or CD ROM in certified pdf format
- Snapshot export in different formats (Excel, Access, Mysql, Oracle,…)
- External flows integration
- Medical devices communication
- Direct support to centres
Our platform is very competitive in costs. Our prices are calculated with an algorithm based on effective pages, checks, services and functions, number of patients.
The future is mobile, also for Clinical Studies. We are developing e.Smart APP for IOS and Android
Aram develops medical and pharmaceutical software, data entry, clinical studies and medical devices interfaces.