Clinitrac engages Dendrite to support eDiary users for a global clinical trial

Clinitrac, a Swedish developer of one of the world's first wireless patient diaries, has selected Dendrite Clinical to provide telephone support for a year-long, multi-country clinical study for one of Clinitrac's premier pharmaceutical customers.

The support contract, which commenced in December 2003, encompasses 51 investigator sites in 13 countries, with Dendrite providing assistance to patients and investigators using Clinitrac's leading eDiary Electronic Data Capture solution.

'The use of innovative technology in the critical gathering and management of clinical trial data continues to expand,' said Cort Grey, director of sales and marketing for Dendrite Clinical. 'However, like all technology implementations, the human support side must not be forgotten. We are pleased to provide this vital element of support to Clinitrac and its pharmaceutical client.'

Mikael Reimerson, senior vp of Clinitrac AB,added: 'The expansion of Clinitrac's eDiary business reflects growing acceptance by pharmaceutical companies and the Food and Drug Administration of the use of eDiaries during clinical trials. Dendrite is well aware of the challenges of conducting global clinical trials and the evolving use of technology to solve these challenges. The company brings global presence, pharmaceutical expertise and clinical experience, as well as services that include local language accommodation and 24-hour customer service for clinics and sponsors.'

Designed to help pharmaceutical companies increase clinical trial efficiency and data validity, as well as decrease time-to-market, the wireless patient diary is a palm-sized hand-held computer with a built-in mobile phone that requires no installation, wires, or connections. The touch-sensitive screen allows the patient to answer study questionnaires merely by tapping symbols on the screen as they are presented. As the patient answers the questions, information is time-stamped and encrypted.

After all questions have been answered, the data is immediately transferred over a mobile phone network to a central server. Via a secure website, investigators/study nurses, monitors, and other sponsor staff can proactively manage patients and enhance compliance.

The Clinitrac eDiary provides easy access to data and the ability to track, in real time, the progression of the study as well as enrolled patients.

'The market for electronic diaries in clinical trials has left its infancy and is now growing at a pace of 50% a year,' commented Andreas Seggeros, ceo of Clinitrac. 'More and more effort is being put into refining trial procedures and conducting pivotal trials that have the highest possible compliance and data validity.'

Dendrite Clinical is a provider of clinical trial effectiveness solutions to bring unique, targeted, efficient, and speed-driven approaches to the support and operation of clinical trials, along with risk identification and assessment solutions to pharmaceutical pharmacovigilance and safety initiatives.