Offshore QA helps telehealth company launch in-home testing app
As consumers continue to embrace telehealth tools such as biometric blood pressure and glucose monitors to track their care, researchers are using the devices in a different way --- as part of clinical drug trials.
The U.S. Department of Health and Human Services says that traditional clinical trial costs have skyrocketed over the past decade. Time requirements, distance from the study site, number of site visits expected, and transportation concerns make it difficult to recruit patients for trials. Consequently, these obstacles contribute to high dropout rates, causing long delays and increasing the risk of trial failure.
Our client, a leading telehealth-based, real-time patient management organization, saw an opportunity to help drive this revolution.
Senior Vice President for Research in the Clinical Trials Division of the client, said, "The economic pressure to bring new drugs to market faster and at a lower invested cost is enormous. Yet many pharmaceutical companies are finding it increasingly difficult to complete clinical trials on a timely basis. Recent changes in FDA guidance are making telemedicine an attractive, cost-effective alternative."
The company’s goal of entering the pharmaceutical market, however, was predicated on making a significant technology update to its flagship SaaS-based product. The platform was already helping patients stay healthier and avoid hospitalization by collecting patient data remotely, and connecting them virtually with clinicians. By leveraging the platform for clinical trials, the client believed they could improve the quality of studies, reduce costs, and provide a better experience for study participants.
Selecting a QA partner who could ramp up quickly
The key to success was selecting a QA partner that could ramp up quickly on their product’s platform and comply with FDA guidelines related to quality.
Due to its low cost and high quality reputation, MATRIX Global Delivery Services in India was selected to lead the testing activities for functional testing of the platform. The entire scope of the project included:
Understanding and process adherence to FDA Code of Federal Regulations, Title 21, Part 820.30, Quality System Regulation; and Title 21, Part 11, Design Controls Electronic Records; Electronic Signatures
Educating team and others (including client management) on FDA requirements
Understanding the clinical trials domain and existing system
Aligning with the client SDLC processes
Testing management including end-to-end testing life cycle (test strategy, test estimates, test planning, designing and executing test scripts, defect management)
Assuring quality of biometric device integrations including digital scale, thermometer, blood pressure monitor, blood glucose monitor, pulse oximeter, and medication monitors
Collaboration challenges handled in real-time
With software development occurring in three countries (Argentina, Ukraine, and India) it was critical to have streamlined communications with each team. MATRIX Global Delivery led the testing activities of different client vendors from Ukraine. In doing so, the MATRIX QA specialists and the developer learned and managed a virtual office solution (Sococo), which recreated the personal proximity and functionality of a physical office in an online experience.
The client’s VP of Product Management said that time zones and cultural differences made little distinction between QA and development. “MATRIX Global Delivery is truly a real-time collaboration team,” he said. “We overlap on average six or seven hours a day which helps us align and have better communication. Geography makes no difference.”
He noted that other offshore teams he has worked with typically communicated in 12 or 24-hour delayed cycles, with nothing approaching real-time collaboration. Based in Bangalore, India, MATRIX Global Delivery’s local working hours were 4 pm to 1 am, with early morning daily standup meetings occurring at 12:30 am India Standard Time (3 pm US EST).
Upgrades to technology stack
Along with coming up to speed on FDA requirements and how to set up a virtual office, MATRIX Global Delivery was also tasked with adopting new technologies and tools pre-selected by the client for its technology stack upgrade. The MATRIX Global Delivery Services team, led by Associate Vice President Jagadish Gokavarapu, quickly jumped in and became functional on the following tools/technologies:
Cassandra: an open source distributed database management system
MongoDB: a cross-platform document-oriented database
Jama: a collaborative web-based application designed to help companies manage projects that relate to the development and introduction of products
Jenkins: an open source continuous integration tool written in Java
“The tools that our team wanted to use internally for managing development, testing, and project management are not tools that are very common in the industry,” said the client. “Nevertheless, MATRIX Global Delivery came up to speed readily on them and actually helped train our team while they were learning themselves.”
Praise for the product and the process
On time and on budget, the client was able to meet their product release deadline with a high-quality product and achieved positive feedback from an external FDA Audit.
MATRIX Global Delivery has gained significant knowledge about the product. As a result, they have been asked to participate on future requirements’ development teams and to lead test management for future testing projects.
“MATRIX Global Delivery has really helped us mature the offshore QA process,” said the client. “They have taken the lead in working out the kinks with our VP of engineering.”
Best of all, several large pharmaceutical companies are using the client’s technologies as a way to accelerate and improve recruitment and trial completion, reduce dropouts, and enhance collection of real-world biometric data and patient-reported outcomes.