5 May 2020 Blog
Traditional vs. Remote Approach to Clinical Trial Monitoring

As the world was brought to an abrupt halt, the importance of adopting digital technologies has become apparent in all spheres of life, especially so for industries. Will the healthcare and pharmaceutical industry is quickly adopt digital technologies, , in these turbulent times, to fulfill their duty of saving lives and to attain their business goals?

Take the case of clinical trials. The FDA’s requires all sponsors to monitor and validate the process of clinical trials to ensure their integrity. Traditionally, this resulted in a whole lot of work for sponsors and CROs alike, as sponsors undertook site visits to inspect the Contract Research Organization’s (CRO’s) site, its facilities, equipment, personnel, while CROs had to maintain processes and regulatory documentation.

In 2011, the FDA issued modified guidance to encourage more remote processes at reduced cost. Nine years later, the pandemic COVID-19 exerted a very strong negative effect on the conduct of with the closure of one-third of trial sites while nearly 77% of ongoing clinical trials in the USA alone, proving that trials are still not being monitored remotely. After this wake-up call, let’s hope that sponsors and sites alike would take advantage of the advanced technologies available to them to make the remote monitoring of a clinical trial not just possible, but also preferable -given how we may all have to veer towards social distancing and avoid travel, as a way of life.

Data point verification to risk-based monitoring, and everything else in between is possible even when your CRO uses an Electronic Data Capture system (EDC) or a Clinical Trial Management System (CTMS). The AI-powered data analytics modules of such technologies enable the identification of outliers in the data at an early stage and make it possible for the sponsor or CRO to identify risks early and mitigate problems with the trial.

Imagine having the ability to achieve everything the traditional methods could, without any need for travel. What’s more, this would not just improve the efficiency and productivity of a clinical trial but would also shorten the drug candidate’s time to market and reduce costs by up to 30% of the cost of the project. The monitoring happens on the cloud, in a secure environment even as the trials take place in multiple global environments. Remote monitoring allows patients the luxury of not having to travel, encouraging patient recruitment numbers and their retention during the course of the trial.

Using technology, we can track trials remotely and transition from site-based conventional models to mixed models or decentralized models which use electronic content forms, wearables, e-diaries and even remote visits. Research has shown how remote methods keep the number of dropouts also significantly lower when compared to traditional models. The ability to meet the trial’s requirement remotely frees up a patient from the burden of making plans to travel, while fighting the effects of a disease. On the other hand, the research teams could expand the scope of their trials to include patients from around the world, transcending physical barriers to ignore factors like gender, race, age, location and even their ability to travel. The ability to continuously monitor clinical data across one’s portfolio in real-time makes it easier to keep the trials on track, mitigate risks and shorten the time to market.


About MaxisIT:

MaxisIT’s Clinical Trials Oversight System (CTOS) enables “data-driven digital transformation” by its complete AI enabled analytics platform from data ingestion, processing, analysis to in-time clinical intelligence by establishing value of data, improve efficiency and empower clinical stakeholders to mitigate risks or seize the opportunity. The CTOS platform helps clinical operations, clinical data management, biostatistics, and clinical R&D portfolio management by bringing clinical operations and patient data together in a single, central data hub (i.e. single-source of truth). The platform allows self-service analytics and role-based clinical intelligence enabling insights, time & cost efficiency, risk mitigation and the effective management of portfolio, data quality, patient safety, CRO/site performance management. In short, it helps you maintain an ongoing health-check on your portfolio of clinical trials, using real-time data, analytics and visualization to drive rigorous analysis of the entire dataset, allowing for proactive trial risk management.

We simplify the monitoring process, feeding all data through a single repository, running robust analytics and ultimately producing visualizations that are fit for human consumption. Because, yes, complex data analysis can produce simple insights. Real-time data ingestion, analytics and visualization empower researchers to identify errors as they occur.

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