eCRF Clinical trials – The History
Our eCRF experience starts in 1999 with Bayer Italia. The requirement is to create a powerful system for the data entry of their clinical trials. So the first eCRF system allows double data entry and has a client interface to design and organize the pages of the eCRF.
Then we validate the system and make it compliant with the regulations for electronic data capture, in particularly with FDA requirements.
In 2004 the system becomes a service: Aram designs the eCRF. In this way our Customers save resources and costs for training and implementing.
In 2010 eSMART becomes a Web platform. It’s an important step for us to overcome the installation problems and to let all the users of the trial to access always and everywhere to their clinical study.
Now eSMART centralizes all the data and services in cloud.
eSMART has been created by expert analyst and developers following software engineering techniques. On the other side the experience of researchers has been fundamental for the evolution of the system.
eCRF Clinical trials – Is for you
eSMART is for you because it is suitable to very small studies and for big and complex ones.
Our customers are:
- Clinical Trial Professionals
- Research Centers
- Medical Device Companies
- Pharmaceutical Companies
- Research foundations
- Scientific associations
- Indipendent institutions
eCRF Clinical trials – 3 Main strengths
eSmart is a Web application and for this it is ALWAYS and EVERYWHERE available.
e.Smart can be definited by 3 adjectives:
Simple because its interface is very intuitive and simply to use. The training on the platform is very fast and often a remote session is enough to learn how to use the eCRF system. A short and simple training is necessary for the first study to understand all the functions. For the next studies the interface is the same
Fast because has been developed in an efficient way using the best programming tools. Once login with authentication 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 the experience on the field.
We have spent a lot of energies to guarantee an high level security.
Security is guaranteed by:
- Two levels authentication in critical parts
- Audit trail
- Different user levels
- Warning and alerts
- Scheduled periodical backup
- Last https certificate security
- Crypted password
eCRF Clinical trials - Validation
eSmart engine has been validated following validation procedures based on Risk analysis, following GxP requirements.
Data entry has these features that are maintained during all the clinical trial
eCRF clinical trials - the Architecture
The system is available in two different architectures according to customer’s requirements.
The first architecture is suitable for the 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 webserver and has these features:
- eCRF development
- eCRF installation on Customer’s Webserver
- Also in this solution is possible use of e.Smart Cloud services
eCRF clinical trials - Main functions
e.Smart innovative eCRF platform has these functions:
- autonomous management of the centers
- Users type management
- Users management, access by user and password
- Controls on data entry
- Edit checks inside a visit or between visits
- Image upload (es. Exams)
- Drug management
- Laboratory exams
- Ongoing statistics
- Integrated quiz and interviews
- Personalized and punctual reporting
- Query on going
- Data entry and alert for Adverse Events (SAE)
- 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,…)
eCRF clinical trials - Services
- External flows integration
- Medical devices communication
- Direct support to centres
- eLearning platform
- laboratory and ranges management by center
eCRF clinical trials - Costs
Our eCRF platform is very competitive in costs.
Our prices are based on effective pages, checks, services and functions, number of patients.