How one virtual research organization leveled-up their quality processes to scale growth

Taking control of quality management

‍

With the COVID-19 pandemic catalyzing the shift toward digital health solutions, virtual research organizations such as ObvioHealth have found themselves perfectly positioned to leverage their expertise in order to offer seamless decentralized and hybrid clinical trials. As a fast-growing organization in a booming industry, ObvioHealth realized the need for a collaborative, scalable enterprise quality management system(EQMS), which led them to adopt Montrium’s Quality Connect platform. Since implementing Quality Connect in March 2021,ObvioHealth has noticed a remarkable improvement in efficiency, training oversight, collaboration, and quality management.

Getting rid of friction in quality processes

‍

The customer: ObvioHealth is an innovative virtual research organization based in Orlando, Florida. Since its launch in 2017,ObvioHealth has been pioneering the development of patient-centric mobile applications that facilitate clinical trial participation at a distance. The COVID-19 pandemic has led to the rapid adoption of virtual and hybrid clinical trials, propelling ObvioHealth forward on its growth path.

‍

The challenge: A manual quality system made tasks such as training, SOP development, and document management difficult and time-consuming. Moreover, lack of a centralized quality system added unnecessary complexity to ensuring regulatory compliance.

‍

The solution: Implementing Montrium’s Quality Connect platform allowed ObvioHealth to streamline and optimize all quality-related processes, improved oversight, boosted efficiency, and removed impediments to collaboration.

Leaving manual procedures in the past

‍

Before switching to Quality Connect, ObvioHealth relied on manual systems to manage quality procedures. The manual processes created a number of pain points, namely, an increased amount of time spent on quality-related work and maintaining oversight of operations as the company scaled. “Even though we’re a small company, it became impossible to keep up; it’s really difficult, unless you have a system in place to keep track of training compliance,” stated Margaret Farrell, Director of Quality Assurance at ObvioHealth. The company began looking for a system to control document management, monitor training activities, manage quality incidents, and ultimately, satisfy clients.

Prioritize a product that does the grunt work for you

‍

After evaluating a number of vendors, ObvioHealth chose to partner with Montrium. Montrium’s Quality Connect platform offered a configurable, user-friendly, and cost-effective solution to assist ObvioHealth in developing and executing its quality processes.

‍

“We needed a system in place to ensure compliance in such a heavily regulated industry and to satisfy our customers’ expectations." - Margaret Farrell, Director of Quality Assurance at ObvioHealth.

‍

“With a manual system, it was easy to miss things. With Quality Connect, I can easily track which trainings are overdue, view our progress in releasing SOPs, and access pre-defined reports, all of which has been very helpful,” she added. With the assistance of Quality Connect, ObvioHealth has been able to scale rapidly and without the hindrance of the pain points inherent to manual processes.