Custom Mobile Application Development
Case Studies
Case Study
Application for managing ePRO data and large clinical trials

Q3 developed a Mobile Application to facilitate clinical trials, allowing patients and doctors to record and transmit data to centralized Web servers.

 

Q3 global sourcing model gives the maximum benefit to customers in terms of cost savings, improved quality, access to highly talented professionals, flexibility of operations and reduced time to market.

 

Company Profile

The client is a Belgium and Canadian based global provider of software products and services to the healthcare and pharmaceutical industry with a focus on four major divisions - Pharmaceutical Services, Cardiology Services, Imaging Services and Medical Products. With offices in North America, Europe and Asia, the Client provides solutions to improve the efficiency and effectiveness for healthcare workers and pharmaceutical companies around the world.

 

The Client offers an Electronic Patient Reported Outcome (ePRO) product that include a variety of ePRO functions to suit any protocol need, whether it calls for in-home patient reporting or on-site reporting. Validated or non-validated questionnaires can be loaded to Smartphones, tablet PCs or be web based and used in clinical trials or consumer healthcare projects.

 

Business Situation

ePRO software suite is used by investigators who need to gather data directly from patients – including specific symptom diaries, reactions to investigational therapy and health-related quality of life issues – in order to demonstrate safety and efficacy.

 

The product addresses a critical need where earlier, doctors & investigators were defining the clinical studies on desktop based applications but now the ePRO suite allows collection, management, and monitoring of timely, complete and scientifically compelling data from trial subjects in real time.

 

The Smartphone based application allows medical personnel or Administrators and Investigators to dynamically design studies/applications on desktops, send/install them on hand held devices and smartphones, collect data recorded by the patient, and transmit data through GPRS/Wi-Fi/Acoustic transmission.

 

Challenges

Several technical challenges were overcome by the Q3 development team in order to build the product. Some of them were:

  • Enable run time scripting for users to define sequence of questions based on response of last attempted questions by patients.
  • Build a multi-lingual software with focus on human-computer interaction to support diversified group of people varying in age, races, ethnicity, genders etc.
  • Develop a scalable and extensible application to support pilot clinical trials at initial stages followed by large scale studies in patients that often compare the new product with the currently prescribed treatment.
  • Develop solutions with a rigorous validation process using GAMP4 - a de facto standard for FDA (US Food & Drugs Administration) Applications in the US and to ensure software meets Food and Drug Administration of USA (FD) safety protocols for people undertaking the trials.
  • Achieve minimal data exchange over the air by implementing offline caching and time-stamp.
  • Ensure proper storage and re-transmission of messages/ survey data in case of loss of mobile/internet connectivity.
  • Identify a common graphical product for rendering statistical data android devices.