How does your Clinical Trial Oversight System form your Winning Strategy?

By Suvarnala Mathangi | Date: June 30, 2020 | Blog | 0 Comment(s)

Technology adoption and strategic revisions to processes are redefining clinical trials today. Data collection is taking new approaches, with data from wearables and mobile apps complementing the traditional modes of data collection. The challenge here extends beyond data collection, as the collected data from these diverse sources needs to be integrated and analyzed in real-time to arrive at actionable insights that enable informed decisions.

The time has come for clinical trial sponsors to recognize the critical importance of data collection, aggregation, and integration in managing their trial portfolio. They also need to ensure that the date from trials is standardized and doesn’t demonstrate any variations. Analyzing data for insights when it is not homogeneous could affect the efficiency of a trial and derail its timelines as well as its cost-effectiveness. On the other hand, the ability to source data from disparate sources and integrate it into a single-source-of-truth could offer advantages that include less time, cost, and resources in the conduct of the trial.

We don’t need the COVID-19 pandemic to make us realize that speed is of the essence in any research endeavor like a clinical trial. AI-powered data analytics are able to cut through the time and cost of deriving actionable insights using clinical trial data.  Pharma companies are set to reap the benefits of having its drug development teams work in tandem with their data teams when they adopt an AI-powered clinical trial oversight system, which enables real-time coordination to bring in unprecedented efficiencies. When the data from disparate sources gets integrated into a single-source-of-truth, clinical teams get to make informed, data-driven decisions that accelerate their drug development process significantly.

CROs and pharma companies reap the benefits offered by aggregating and analyzing the data collected from clinical trials to enjoy the insights. They also have an opportunity to make timely decisions with regard to the conduct of their trials and to reap the benefits of innovation in many different ways. The global pharma market today fosters a tremendous amount of competition between the players and the time-to-market is of crucial importance to one’s winning strategy as it offers access to superior revenues to a first mover.

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 the 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 the 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.

What does the Future hold for Pharma Companies?

By Suvarnala Mathangi | Date: June 30, 2020 | Blog | 0 Comment(s)

The global pharmaceutical industry was pegged by some studies to reach USD 1.57 trillion by 2023, based on some market drivers, growth trends and current and upcoming challenges. Meeting these growth predictions will require the industry to master the management of clinical trials and plug the loopholes which were exposed only too well, by the current pandemic situation around the world. This question will need to be answered, even as the industry is focused on fighting the deadly virus and its spread.

As organizations focus on progressing further with the various clinical trials, which are as necessary as ever, there’s a need to move away from many of the earlier processes which required physical access to patients. Thousands of suspended clinical trials can be resumed with a little tweaking of their original operational models provided of course, there’s adoption of suitable technology. The realization that ‘hybrid’ or virtual trials help to reduce costs, increase patient engagement, improve patient experience and compliance has significantly increased the interest in these models.

All these considerations and technology developments are giving rise to interesting trends in patient engagement, healthcare delivery as well as clinical trial management.

Mobile devices: Mobile devices are helping healthcare providers to keep patients informed and engaged. They also help to measure and collect health-related information like blood pressure levels.

Decentralized trials: Sponsors will have to respect the need of trial subjects to stay safe in place and send the supplies and resources needed to participate in a trial to their doorsteps. Technology is set to play a huge role in enabling such virtual trials.

Wearables and Implants:  These smart electronic devices with micro-controllers are seen to be useful to track a person’s fitness and health parameters, till recently. Now they are seen to be reducing the costs for pharma companies and CROs by allowing them to collect clinical trial data, even as the wearer goes about their daily life. Few visits, and no in-clinic monitoring with remote data transmission and collection using technology eliminating any errors in manual collections and calculations! There’s absolutely no downside to this, once the compliance with using the medical data is taken care of.

Personalized medicines: Riding high on the FDA’s commitment to accelerate personalized medicine, pharma products in oncology and neuroscience are especially revolutionizing the go-to-market model of medicine delivery to change healthcare delivery drastically with minimally priced therapies in the coming years.

AI and ML: Accessing an integrated view of the entire trial data for clinical trial oversight and actionable insights using AI-powered technologies with machine learning capabilities is set to revolutionize the design of drugs as well as the conduct of clinical trials to make hyper targeted drugs and precision medicines available.

Cloud computing: The cost savings, competitive advantages and superior efficiencies driven by cloud computing are highly attractive. There’s also a need for better security and lower technology maintenance costs, to which more pharma companies are being drawn.

Pharma as an industry is constantly affected by emerging healthcare needs and rising customer expectations. The need for ongoing research into better treatment options is a constant driver to the industry’s continual research efforts. Rare and orphan diseases are also adding an impetus to these initiatives in developing suitable drug candidates. With billions of dollars being invested into the industry, there’s a lot at stake in the worldwide pharmaceutical markets. This makes it an imperative for the industry to keep pace with the disruptions caused by technology and the changing times.

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.