Electronic Patient Reported Outcomes or ePRO is becoming an increasingly useful tool for evaluating the effect of a treatment in clinical trials; sometimes a patient reported outcome is the sole endpoint available. Given the number of variables, such as costs, validation, sponsors, investigators, patients, data volumes, timeliness, subjectivity, objectivity, no one technology is ideal in every situation.

The temptation for vendors or consultants is to try to fit a trial to a preferred tool, regardless of the specific  needs of the trial; rather than coming up with recommendations for the best overall solution. That is why we believe Perceptive’s ePRO service is unique.

IVRS, IWRS or PDA? – The Perceptive Approach

Perceptive’s ePRO approach involves a mix of discrete skills and services that embrace all the relevant technologies. Taken together, they offer an excellent means of selecting the most appropriate solution for each trial. They enable a sponsor to outsource entire projects for electronic data capture, from initial advice and recommendations, through technology purchase, to trial usage and completion.

Technology Management

Perceptive's ePRO solution, then, spans a variety of technology offerings (IVRS, PDA, IWRS). We adopt a best-of-breed philosophy, involving technology developed in-house, as well as leveraging partnerships with other foremost companies. The selection of the most appropriate technology for a trial depends on many criteria. These include patient population, the type of ePRO questionnaire and the deployment strategy of the project. Our expertise in technology integration means that a sponsor can confidently outsource the hardware and software aspects of ePRO, enabling them to concentrate more on essential clinical issues.

Use of IVRS Technology

When independent assessment suggests IVR as the optimum technology, we use our leading Perceptive Voice™ service. It can handle large call volumes in international settings and accommodate a wide variety of languages and dialects. We will work with you to define the best possible voice script, bearing in mind patient population, clinical objectives and likely patient lifestyle. Our solution can be used to implement IVRS validated versions of PRO Instruments as well as ad hoc patient diaries (e.g. mediation compliance).

Use of IWRS

Perceptive has been involved with web-based data capture since the early days of EDC (electronic data capture). In fact, we have conducted trials involving thousands of patients around the globe and the technologies applied have been numerous. As well as our own proprietary solutions, we have adopted leading 3rd party technology, licensed through technology transfers. We were also pioneers of IWR solutions, developing web-based interfaces to our own leading IVR system.

Use of PDA

Perceptive works with its ePRO partners, PHT and Invivo Data, to provide our customers a best of breed solution when it comes to a scalable ePRO PDA platform. The graphical user interface features body diagram, visual analog scales and other screens to facilitate precise and accurate reporting.

Regulatory Requirements and Guidance

When sponsors are considering the use of ePRO during a trial they need to be well aware of the regulatory requirements and guidance around PRO and eSource.

Working with the right vendor can make a big difference in the success of an ePRO study.  Perceptive and its partners can help clients identify the appropriate data collection strategy, and articulate this strategy to support protocol reviews to various agencies.  Perceptive’s extensive experience and strong regulatory background in the management of electronic source data assists a sponsor in meeting his regulatory obligations.

Training

We train study team members with the goal of making them experts in the use of the chosen ePRO device, diary management and trial procedures. Basic training sessions for users create the right motivation and foster better understanding of the technology, individual roles and responsibilities.

Supervision, Consulting, and Project Management

Of most importance, Perceptive can act as a facilitator between Clinical Studies and IT knowledge, as well as providing regulatory consulting around diary instruments and implementation. We can manage and control issues to help create a successful program.

Service Features

• Consult with clinical teams around instrument validation and communication with regulatory agencies
• Robust in-house IVRS technology
• Strategic relationships with PHT and Invivo Data for PDA ePRO use
  Rapid application deployment
• Tailored ePRO solutions through the Web, portable devices and IVRS
  Effective use of trial information through advanced reporting functionality
• 24x7 multilingual Customer Care around the globe

How do I know which is the most appropriate technology?

How should I choose between IVRS (Interactive Voice Response Systems), IWRS (Interactive Web Response Systems) or PDA (Personal Data Assistant)?

Use Voice when:

• you are dealing with low technology countries or sites (a telephone is always available)
• the questionnaires are short (no long questions or large lists of choices)
• you have no possibility for intensive training
• you don’t need visual channels 

Use PDA when:

• you need to work offline
• you need to use visual information
• you have complex interactions

Use Web when:

• you need to ask complex sets of questions with graphical elements
• you need a good feedback channel to the patients (so that patients can see their own entries and development)
• there is a good technological environment or patients report outcomes at the sites (hardware is available)