Case Studies

Provenda Biometrics: SmithKline Beecham's Large Clinical Trial Data Collection Application 
SmithKline Beecham (SB), a large pharmaceutical company, approached Provenda to design a method for gathering important patient information in a large-scale clinical trial. SmithKline wanted a solution that could query patients randomly during the day and would allow them to make text-based entries on a daily basis.

• NetTrial CE-Diary is a client/server based application, for the Palm-size PC running the Microsoft Windows CE, built by Odyssey Software.

• A modular application with a core system that includes administrative functions and two levels of security:
  • First level is for administrators (doctors and nurses) to access data and application functions, including site password.
  • Second level is for patients featuring a power-on password and also a second patient-specific password allowing entry of personal data.
• On top of the core system resides the customized forms for specific studies; the customization feature can include 100 screens or more depending on the study.
• The application could logically branch out, depending on the patient’s response, to collect detail information.
• Others features include an alarm to alert patients that it is time to enter data and safeguards to ensure data entries were made in real-time.

• Philips Nino 300 Series model with 8MB of memory
• Central Server to which all data is transmitted

• Provenda provided 140 Palm-size devices for distribution to patients via their doctors.
• Patients recorded their condition daily, and depending on their responses, they could be taken through as many as 30 screens.
• Prompts were used to verify that they made the correct entry after tapping in the answer, making it easy to correct mistaken entries on the spot.
• When the patient visited their physician, the doctor uploaded the patient’s data, using the attached modem to the Philips Nino unit, to Provenda database, which collates the information and forwards it to SB for analysis.
• Eventually data will be transmitted to Provenda from the patient’s home each day.

Traditional Methods: Paper-based and IVR

• Patients submitted recorded data in paper-based diaries or via Interactive Voice Response systems (IVR), which allowed patients to use the phone to respond to recorded questions.
• Paper-based methods were slow and not reliable, providing little control over the quality and timeliness of the patient’s use of the requisite forms.
• While IVR systems were fine for many applications, they were not always discreet in handling sensitive or embarrassing questions.

• They could not accept text entries.
• They were also difficult to program to contact patients at a certain time.

• The handheld device increased the rate of patients compliance significantly compared to paper-based methods.
• Patient response was positive.
• Reduced the potential for human error miscommunication that could hamper the validity of a clinical trial.
• SB received more, reliable data faster thus enabling them to follow-up with physicians and patients during the trial.

For more information:
Wireless Applications in the Health Care Industry, click here.

External Sources of Information:
www.microsoft.com/mobile/enterprise/case/cs-provenda.asp
www.provenda.com
www.odysseysoftware.com