Clinphone unveils online data capture for clinical trials information

ClinPhone Group has unveiled an Electronic Data Capture (EDC) system that will help pharmaceutical companies eliminate logistical and validation issues for data collection during clinical trials. ClinPhone believes the new service will drive down costs for drug development and dramatically reduce clinical trial timelines.

The new system, ClinPhone-edc, eliminates traditional data collection and query resolution while allowing the transfer of clean data sets to the trial database. Investigators participating in a clinical trial will be provided with a ClinPhone-edc configured laptop or ClinPhone-edc software to input trial patient data.

A hybrid of online and offline technology, ClinPhone-edc provides investigators with a familiar web-style interface, which facilitates simple navigation between electronic Case Report Forms (eCRFs). It does not depend on an Internet connection to allow data capture, providing flexibility for data to be entered offline and sent to the central database later when an Internet connection is made.

The system uses TCP/IP as its mode of communication with the central server, eliminating the need for a web server. The system is therefore more secure than a web server-based EDC system. It also automatically maintains a complete audit trail of all data changes including explanations for these changes. Central site data and remote site data are synchronized automatically during each online session.

One of ClinPhone-edc's key innovations is the ability for data to be entered and reviewed offline before it is forwarded online to the database. The data synchronisation elements of the system ensure data transfer and replication is automatically fully validated and complies with FDA requirements.

ClinPhone-edc can be customized to a sponsor's specific requirements, offering specific configuration of eCRFs, data tables, data dictionaries, and data export routines.

"We have created a simple data capture and validation process which dramatically reduces the cycle time of Phase I-IV clinical trials and accelerates the drug development process," commented joint managing director Neil Rotherham. "The unique architecture of ClinPhone-edc means sponsors benefit from the versatility and cost effectiveness of the Internet as a communication medium and a working environment which offers the stability, integrity, and speed of a locally executed Windows application."

For more information: Patrick Hughes, Group Marketing Director, ClinPhone Ltd., Lady Bay House, Meadow Grove, Nottingham NG2 3HF. Tel: +44 115 955 7333. Fax: +44 115 955 7555.

Edited by Angelo DePalma
Managing Editor, Drug Discovery Online