Cyntegrity optimizes clinical trials with MongoDB Atlas

INTRODUCTION

Making clinical trials safer and more effective

Behind every trusted medication, there are years of clinical research—testing the safety, side effects, and outcomes of new drugs. To achieve accurate results, biopharmaceutical companies rely on high-quality data coming out of research. However, capturing, managing, and analyzing that data can be challenging. Cyntegrity is a leading provider of AI-augmented, risk-based quality management (RBQM), and its RBQM portal uses MongoDB Atlas to give clients deeper insights from their clinical trial data.

“Cyntegrity was founded in 2013 to protect the integrity of clinical data during trials. Our risk management platform enables customers to tap into their data to detect issues that could cause delays or influence the outcome of their trial,” says Artem Andrianov, CEO and Founder of Cyntegrity.

The Cyntegrity platform— MyRBQM® Portal—is used by pharmaceutical companies and regulators to make the pharmaceutical industry safer and to accelerate life-changing research. It makes it easier for scientists to grant role-based access to data to the right people, keeping sensitive data secure. MyRBQM also adds time stamps to data to create accurate audit trails. The portal improves monitoring efficiency throughout the clinical trial, by giving study teams one place to manage risks. It also uses AI-augmented logic to make data actionable. For example, it can predict trial length based on previous trials and actual data, which enables customers to mitigate and budget accordingly. The portal can also help detect duplicate study results, which may indicate that participants in the trial have submitted fraudulent findings.

“Around 80% of clinical trials finish late, and that can have a huge financial impact,” Andrianov explains. “A patent for a new drug lasts 25 years, but it can take 14 years to get it to market. The faster companies can safely conduct the trials, the longer they’ll have to sell the drug exclusively on the market before the patent expires.”

Regulatory bodies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA) also use MyRBQM to track clinical trial data, which is vital for verifying research and boosting the overall integrity of clinical trials.

“Regulatory bodies have a huge volume of work to get through, which can cause bottlenecks,” says Linda Bunschoten, Chief Marketing Officer at Cyntegrity. “Our platform speeds up go-to-market timelines and reduces the risks of companies going to market without the necessary compliance checks.”

THE CHALLENGE

Connecting to disparate data sources and supporting longitudinal studies

When Cyntegrity began developing its MyRBQM portal, it needed a database that was scalable, highly available, and accessible. Cyntegrity wanted a cloud-based solution that could connect to the multiple systems of record that its customers use for clinical trials. It was also important for the database to support longitudinal studies so that researchers could repeatedly examine the same data points to detect changes over time.

With customers all over the world, Cyntegrity also needed to comply with local regulations around data sovereignty and residency, while ensuring customer data was always protected from outages.

In addition, the user experience was top of mind for Cyntegrity while searching for the right database solution. Its clinical researchers were used to working with data, however they were not deep technical experts, and often relied on paper forms or spreadsheets to do their analyses. Therefore, the chosen database platform needed to be user friendly with intuitive tools to query and visualize complex data. Cyntegrity also wanted to create a familiar, desktop-like user experience, and set itself a target of delivering load times of no more than 1.5 seconds.

“We started looking for a database with a flexible document model and strong security,” says Andrianov. “As well as being stable and reliable, it also needed to be able to support advanced capabilities and multi-tenancy.”

THE SOLUTION

Implementing a high-performing cloud database with rich functionality

As a startup in 2013, Cyntegrity used the open-source version of MongoDB. Over the next 11 years, MongoDB grew and evolved to meet the company’s changing needs. Cyntegrity then, in 2015, migrated from an on-premises instance to MongoDB Atlas on Microsoft Azure, using official documentation to manage the implementation in-house.

Cyntegrity assessed over five databases on the market, including SQL databases, which the team had used previously. During testing, MongoDB performed 10 times faster than competing products and comfortably met the 1.5-second load time requirement. In addition, the MongoDB document data model supported a variety of medical data without the need for complex schemas.

With MongoDB Atlas being a cloud-based, fully managed database, Cyntegrity benefits from the latest system upgrades and has freed up its team from manual updates and other time-consuming maintenance tasks.

“MongoDB was the best fit for our needs in 2013 and is the best fit for us today. It has a flexible document model and features such as indexing and transactions that have continuously improved over time,” Andrianov reveals. “We’ve set up multi-tenancy, and we can serve customers across the US, Europe, and China easily while complying with their data residency and sovereignty requirements.”

The multi-cluster setup and integration with Cyntegrity’s backup solution has been a huge advantage. If one node goes down, there are two more available to keep the portal available around the clock.

To support longitudinal studies, MongoDB Time Series Collections ensure that every time-stamped customer data point is preserved with its original context. This provides the longitudinal insight required to detect anomalies or duplicate results. This is also valuable to regulators and helps Cyntegrity make accurate predictions on how long a clinical trial is likely to take, or to detect any issues that could change the outcome.

Helping Cyntegrity’s clients save costs and eliminate fraud

During clinical studies, the Cyntegrity portal captures datasets with multiple timestamps. There are three timestamps per data point, which ensures every piece of data is verifiable. This helps with compliance, provides transparency, and gives scientists an audit trail and a deeper understanding of the reasoning behind decisions that were made at various points in the study.

Multiple users can collaborate on the portal simultaneously without delays or version control issues. Data is updated in real-time, and thanks to the scalability of the Atlas platform, there’s no latency during peak periods.

“To understand the impact of MongoDB, it helps to see it in action. One large pharmaceutical company had successfully completed trials in the US and Europe, only to see the study fail in China,” explains Andrianov. “When they analyzed why it failed, MongoDB flagged 99% duplication between the outcomes from two medical centers.”

By submitting duplicate results instead of carrying out the study properly, one medical center caused the study to fail and cost the pharmaceutical company millions of dollars. Cyntegrity was able to identify that the study’s failure could be attributed to human error rather than the drug itself, and the pharmaceutical company awarded Cyntegrity a contract for all its life science studies moving forward.

In another case, Cyntegrity used a company’s historical trial data to predict how long its biggest clinical trial would take. The company projected just two months, but Cyntegrity suggested it should allocate resources for a year. “The company didn’t believe us at first, but using machine learning in MongoDB, our estimate proved accurate down to two weeks,” adds Andrianov.

THE RESULTS

10 times faster performance and 99.99% availability

With MongoDB, Cyntegrity has strengthened its position as a cutting-edge software company in the biopharmaceutical industry. Its portal has 99.99% availability and is so reliable that the company broadcasts its system status live on the website—testing load times every five minutes.

“Many competitors use SQL databases, so MongoDB gives us an advantage. It’s flexible, ten times faster, and we don’t need to put much work into maintaining it,” says Andrianov. Cyntegrity needs just one individual to maintain its infrastructure, estimating it would need to hire 20 people to manage an SQL database.

In addition to high-performance levels and security, MongoDB is more cost-effective and agile. Cyntegrity can implement new features quickly, which enables it to explore innovative technologies, including machine learning and generative AI.

“MongoDB is great for us and great for our customers. It supports our mission of raising the standard of clinical trials by helping customers predict timescales, eliminate fraud, and optimize their costs,” says Bunschoten.

From quick wins, such as identifying if two labs are using different units to measure samples, to identifying fraudulent submissions, Cyntegrity is doing important work to improve patient outcomes while the industry develops innovative new medicines. Its customers can quickly, within just hours, identify and fix issues that slow down drug development and standardize quality controls across patients, hospitals, and countries.

Having demonstrated the power of data integrity, Cyntegrity hopes to move the industry toward collaborating with anonymized data to identify and eliminate global risks. “Companies can learn a lot from their data, but in the long-term, it would be great to see the industry collaborating for the greater good,” concludes Andrianov. “With MongoDB, we can scale and adapt to whatever the future brings.”