The concept of integrating technology into the conduct and management of clinical trials is not a new one. However, the advent of the global COVID-19 pandemic in early 2020 made apparent the consequences of staying static with tools of the past. In a short time, biopharma and biotech sponsors around the world had to adapt and scale their operations to overcome unexpected delays. With the rise of advances in medical and health technology, clinical trial research is entering a new age wherein new solutions are being developed by forward-thinking contract research organizations (CROs). Sponsors should consider the following technologies when choosing a CRO to best optimize the delivery of their study design.
CRO Tech #1: Intelligent Data Capture
The quality of a clinical trial ultimately hinges on the quality of its patient data. With the use of specific digital tools, clinical research sites can streamline their data collection processes. Often, sites are inundated with multiple patient visits in a day, followed by stacks of paperwork to slowly transcribe electronically. By embracing technology that enables intelligent data capture, sites become increasingly efficient with their time and reduce the risk of protocol deviations.
eConsent allows sites to keep patients apprised of the most updated consenting information approved by the sponsor and the ethics committee while retaining all signed copies in a centralized platform without the need for paper-based records.
eSource is a user-friendly system that allows for real-time data capture, replacing the use of paper. Furthermore, because this platform directly integrates with EDC, site staff are spared the task of double data entry.
CRO Tech #2: Patient Recruitment Engine
Slow patient enrollment is one of the most daunting challenges facing any clinical trial, but it often determines how successful a study will be. When choosing a CRO, sponsors must not underestimate the importance of established proactive recruitment measures. Finding the right patients often proves to be difficult, but many CROs will offer resources to offset this common obstacle.
Electronic Medical Record (EMR) aggregation is becoming increasingly possible. With the introduction of software that processes EMR patient data, sites can carry out patient-trial matching and rule out ineligible candidates without having to resort to time-consuming manual data mining.
CRO Tech #3: Remote Data Monitoring
Clinical data management and monitoring are one of the most crucial administrative tasks as clinical trials progress to ensure proper data collection. Many innovative CROs will offer their own technology solutions to streamline data monitoring. The traditional method of site visits at periodic intervals can limit just how much clinical research associates (CRAs) are able to review. Remote monitoring tools allow for a unified platform in which site staff can store their documents, and CRO or sponsor CRAs can perform source data verification more quickly.
Vial offers an eTMF powered by Egnyte helps facilitate the sharing of essential clinical trial documentation with all stakeholders without the hassle of paper-based filing. Such a tool is used by CROs to allow for centralized management throughout a study and optimization of document security.
eISF platforms are the site counterpart of eTMFs, allowing for digital storage of essential clinical trial documents for CRO or sponsor CRAs to review in real-time.
The Vial EDC software accelerates the efficiency and value of their clients’ clinical studies. It is a secure cloud-based platform that enables straightforward real-time eCRF data input and easy integration with Vial’s technology workflow. Sponsors can also benefit from a feature-rich query management suite for effective remote data monitoring.
CRO Tech #4: Remote Patient Monitoring
Delivering remote care through the implementation of mobile data collection devices, as well as any integration with iOS/Android apps, offers significant advantages to site physicians. These technologies were designed to enhance the patient experience by increasing trial flexibility while still allowing sponsors to meet regulatory and reporting standards. Advances in artificial intelligence tools will also allow for easier detection of key patterns in large datasets for biotech companies looking to find new research leads.
The Vial ePRO provides biotech sponsors with a user-friendly interface that is accessible to patients at home and on their own devices (mobile, tablet, desktop) for intuitive and compliant data capture. With seamless workflow crosstalk, the ePRO technology is connected to the Vial EDC for accurate efficient data recording.
Technology That Drives Efficiency
The rise of CRO outsourcing has driven the advance of digital clinical trial tools even further. Biotech sponsors should consider the capacity of a potential CRO partner to deliver technology that drives efficiency and solutions to key challenges faced by organizations, such as slow recruitment, COVID-19 limitations, and inefficient administrative processes. Vial’s streamlined workflow of various data management and remote monitoring tools ensures sponsors that we have the right experience and vision for advancing clinical research out of the paper era. Learn more about how we’re reimagining clinical trials at https://vial.com/.
