Ensure Successful Outcomes to the Digital Revolution in Pharma

By Suvarnala Mathangi | Date: May 31, 2020 | Blog | 0 Comment(s)

Many drug candidates and ongoing research studies into their efficacy received serious setbacks when COVID-19 resulted in the total closure of many trial study sites. There’s no saying when these studies will resume and bring deserving drug candidates to the market, to benefit a number of patients who need them, even today. This disruption to patient visits to trial sites for submitting data or receive drug administration has no end in sight, unless we strike off on a new path and transform our processes.

With global lockdowns, social distancing and closed borders, there’s no doubt that digitization has been a great help to many of us. Pharma companies need to focus on improving outcomes and managing costs when testing the efficacy of their drugs, not just in a randomized clinical trial, but in the market as payors and governments alike are looking for drugs with a demonstrated value before they would consider paying a premium for them. This makes it necessary to pick the right digital tools by evaluating the promised outcomes and their desirability in the scheme of things.

Virtual clinical trials have less site dependence. They depend more on telehealth and telemedicine applications. They are aligned with mobile healthcare providers and do not require the trial subjects to visit any site. The conduct all tests virtually, or at some local laboratories or mobile facilities. All consultations can happen over text messages, or audio/video calls. Trial subjects can also get the drugs and delivery devices needed shipped to their addresses, with virtual supervision and nurse assistance being offered 24×7 as support. Data gets collected virtually or through mobile healthcare providers.

Many drug sponsors are becoming suddenly more interested in participating in the digital revolution happening in pharmaceuticals and healthcare are looking for the winning strategy. How assured is digital success? How are we to choose the right initiative? The answer to such questions is not far to seek.

In these highly turbulent times, digitization steps in with various solutions to ease our passage, by:

• Empowering patients through the use of apps, health and fitness wearables and participation in online forums.
• Making patients responsible for their own health and offering them online resources to escalate issues for support through telemedicine, when needed.
• Using sensors which collect and analyze data while constantly monitoring a patient’s health status without their having to visit any healthcare provider.
• Generating data on the patient’s adherence to treatment and collecting a patient’s health data on a regular basis, using remote means.
• Proving the efficacy of a drug using the data generated.
• Creating new and independent channels to share information about drug products, their safety, effectiveness, performance and even on their interactions with other drugs.
• Achieving real-time transparency across the performance of their clinical trials.

Technology today is also helping to automate some complex decisions, and helping to streamline and improve the business processes to offer superior quality, execution times and efficiency. This is heralding a sea change in clinical trial process, as more and more sponsors are adopting tools which improve the management of their clinical trials, across geographies.

Remember, that the opportunities to adopt digital technologies are many and varied. It’s possible to really adopt digitization only when companies identify the right initiatives, and truly embrace the opportunity, whether using mobile communications, cloud-based tools and apps, advanced analytics or the Internet of Things. Here’s to more efficiency and speed-to-market and ultimate success in all your endeavors.

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.

Traditional vs. Remote Approach to Clinical Trial Monitoring

By Suvarnala Mathangi | Date: May 31, 2020 | Blog | 0 Comment(s)

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.