.CRF

.CRF - Electronic Data Capture and Workflow System for Clinical Trials

.CRF is the framework that is quickly customized into the solution for specific needs rather then having the clients to adapt to solution and change the way they work. This way more flexibility to our clients is provided.
Behind the .CRF is a professional organization with highly educated employees ensuring continuity of the customization and development of the solution and understanding the needs of the users. This is especially important for small to medium sized companies that lack support of a large IT department.


Architecture

.CRF is an enterprise-scale Web-based application which meets the demands of enterprise computing over an Internet standard distributed network infrastructure. The system can be accessed by any client capable of running a web browser. It has advantages such as:

  • Centralized maintenance, administration and upgrading
  • Availability to all users regardless of their physical location
  • Reduced network traffic
  • Transaction mechanisms ensure data integrity and consistency in case of any system failure

Solution is built using modern n-tier system architecture and is based on several industry standard platforms and technologies. Business logic tier consist of:

  • Microsoft Windows 2000/2003 Server
  • Microsoft Internet Information Server
  • Microsoft .Net Framework

The data tier is built primarily using Microsoft SQL Server 2000 (Oracle is also supported).

On the user side, the following client platforms are supported:

  • Microsoft Windows NT 4.0/98/2000/XP, Mac, Linux
  • Netscape Communicator 4.5+
  • Microsoft Internet Explorer 5.5+

Solution

Most research takes place in different centers simultaneously. These are often located in different cities or even in different countries. It is required to prepare and distribute/dispatch all the materials - protocols, forms, etc to all the centers. Later, it is required to gather all the forms, ensure that the data is valid and prepare the data for statistical analysis or certification process. Although this process seems rather simple and straightforward, it is very delicate and time consuming. The situation can become more complex if some data is missing or is not provided in appropriate form, if numerical values are out of range, if data are inconsistent, etc.

.CRF is a user-friendly, scalable and secure web application that has all the characteristics mentioned above. It runs from any standard web browser and offers many advantages compared to traditional methods of gathering data via paper forms or classic applications. Data is entered at the source, in clinics.

This way it is possible to avoid or at least to reduce the number of queries to the centers at later stages and most of issues regarding the validity and integrity of data are solved at the source.

The user interface is standardized and intuitive across all data forms. The data entry system is both quick and easy to use. It supports a silent “heads down” entry mode or “heads up” mode where data entry operators are notified of all system generated discrepancies. The system supports “single entry” mode of data entry, while the “double entry” with or without verification is an option.

The validation system is implemented that warns the user if the data is different from what is expected. All warnings are displayed at the top of the form in the warning summary. Each warning listed in the summary is also repeated next to the value it validates helping the user to quickly find the possible problems on the form.

The process of issuing and managing queries is established as a part of the verification workflow between data entry and data manager personnel and finishes with the verification of the form.

The reporting section of the solution consists of two types of the reports:

  • Built-in reports which help the data managers in data verification process monitor the progress of the whole Clinical Trial and list administrative data in the solution (user lists and permissions, location list, etc.)
  • Custom-made reports developed to meet requirements of specific clinical trial or of specific group of users (CROs, sponsors).

Workflow is integrated in all forms and is customizable. E-mail or mobile device notification is also an option and can be enabled in all phases of the process.

Security is implemented as combination of username/password and roles assigned to the users. Users could be assigned to a specific center or country and they can access only the data that belongs to that center. In fact, they may not even know that there are other centers or countries involved in the study.

There are many other security procedures implemented at the application or system level of the solution. Users could be forced to change passwords at predefined intervals and a minimum length rule for passwords may be set. Security integration of the database with the underlying Operating System may be enforced. Access to the data could be limited to a specific time of the day or a given period of time. Authentication can be implemented in more sophisticated way - i.e. using tokens or smartcards. Encryption ensures that the communication channel between the client (browser) and the application server is secure and data cannot be viewed or changed.