Patient Direct is powered by ClinPhone's state of the art Interactive Voice Response platform – ClinPhone*ivr – and allows the collection of date and time-stamped data from clinical trial patients using their telephone keypads to input information relating to their condition. The ClinPhone IVR system has been used successfully in approaching 500 clinical trials throughout 80 countries.

ClinPhone believes Patient Direct is one of the most comprehensive services of its kind available to the global clinical trials industry and is a major improvement over traditional patient diary systems, which either use paper or complex electronic devices on which the patient records their data. Information is gathered in real-time via the telephone and is therefore available to the trial sponsor instantaneously. The application has been fully validated and ensures accurate and time-stamped data is accessible by all study personnel.

The system can be used in a variety of applications, including symptom assessments, quality of life measurement, health economic questionnaires including country-specific health service receipt questionnaires, patient satisfaction assessments, cognitive function testing and patient-assessed psychiatric rating scales.

There are also significant savings in costs available for anyone opting for Patient Direct. It negates the need for use of hand-held electronic devices, another current method utilised by the industry to gather data from patients, and therefore removes hardware and software issues and the requirement for the patient to be able to use such technology correctly.

Patient compliance can be reported through real-time tracking of calls to the system and will trigger automated non-compliance alerts for sponsor, investigator or partner call centres to instigate active follow-up when necessary. Monitors and investigators can also review the patient calls into the system via ClinPhone’s on-line reporting system.

There is 24/7 access to the system from any country via ClinPhone's international toll-free telephone network, enabling patients to call at any time at their own convenience. The entire application is validated to relevant industry standards, including FDA 21 CFR Part 11.

ClinPhone is planning a series of workshops for the pharmaceutical and biotech industries to introduce the new service. Two workshops are planned in the UK – on April 4th at Ware in Hertfordshire and on April 6th in Bracknell. Further seminars are being planned for US and European venues later in the year.

Further information on both the new Patient Direct service and the forthcoming industry seminars is available via ClinPhone’s web site. Click to www.clinphone.com to view the seminar agenda and register on-line. Alternatively, contact ClinPhone on +44 (0) 1159 557333 or e-mail info@clinphone.com for further details.