Helping pharmaceutical companies bring new therapies to the world faster using analytics for life sciences

Contract research organization Gunvatta uses SAS^® Life Science Analytics Framework on Azure for clinical and health care data analysis and reporting

Since 2000, the US Food and Drug Administration (FDA) has approved more than 500 new medicines to prevent diseases, improve patients’ health and save lives. From drug discovery to FDA approval, developing a new medicine takes an average of 10 years and $2.6 billion.

The clinical research required to achieve FDA approval involves massive amounts of data. Difficulties in managing, sharing and analyzing that data add time and cost, creating delays that affect patients’ wellbeing.

“The primary goal is to get drugs approved so that they can reach patients,” says Bhawna Goel, CEO of Gunvatta, a contract research organization (CRO) headquartered in Washington, DC. “The faster you can do that, the greater benefit for the patient and to help save lives.”

Founded in 2021, Gunvatta’s fast-growing list of current and prospective clients includes pharmaceutical companies that hire CROs to help collect, manage, analyze and visualize terabytes of data produced in clinical trials, then prepare that data for review by health authorities such as the FDA and the Pharmaceuticals and Medical Devices Agency (PMDA).

Gunvatta, which means “quality” in Hindi, also helps hospitals, medical device manufacturers, academic and research institutions and government agencies with time-sensitive health care analytics solutions to support clinical and executive decision making.

An entrepreneurial drive to empower women in STEM

Goel began using SAS software while attending graduate school. Fresh from Rutgers with her MS degree in Statistics, she worked at small CROs that she describes as “one mom-and-pop shop after another.”

“You wear multiple hats when working at smaller companies, and that is what prepared me for the huge undertaking of founding Gunvatta,” Goel says.

Goel relied on SAS for statistical analysis and data reporting required for Phase I-IV clinical studies, which comprise the five-step process required of pharmaceutical companies seeking FDA approval to sell a new prescription drug: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

After holding senior management roles at global biopharmaceutical company AstraZeneca, Goel’s entrepreneurial interests inspired her to found Gunvatta. As she tackles aggressive business development goals for her woman-owned business, she also feeds her passion for learning and empowering young women for careers in analytics and broader STEM areas.

“I want women to be powerful in terms of being independent, especially back home in India,” Goel says, adding that coming to the US in the early 2000s helped bring out her own independence. “That’s what I want to inculcate in the graduates we hire back in India – that you can be whatever you want to be.”

Dealing with big data

As a longtime SAS user, Goel says she was excited and curious to learn about SAS Life Science Analytics Framework. The cloud-based product provides a single, integrated and collaborative environment to manage and analyze clinical trial information as well as deliver trial results for the FDA’s review.

The ability to support that type of robust data environment – and enable data to be quickly and securely accessed – is key, she says, “Because everything is data. Whether it’s wearable technology, electronic data capture (EDC) systems or external health care systems, data needs to be integrated to create useful information and insights. And it’s just going to increase exponentially as technology expands into more areas of our lives.”

“Our job as a vendor is to provide clients what they ask for and ensure its quality, credibility and compliance. SAS Life Science Analytics Framework plays a very important role in how we achieve that.”

As Gunvatta adds more clients and organizations to its orbit, Goel looks forward to using the full potential of what the SAS solution has to offer.

“We want to show new clients our capabilities, so whether it’s the physician, medical scientist, data manager or statistician, they all should be able to access our system directly to access their data, reports and visualizations,” Goel says. “Transparency is key!”

Better workflows and processes

With SAS Life Science Analytics Framework hosted on Azure, Gunvatta has modernized the way it approaches clinical trials. The solution helps Gunvatta reduce risk with secure data access, ensure data and results are validated, maintain an audit trail and help pharmaceutical companies to prepare, report and submit their data to the FDA.

Goel warns big pharmaceuticals against vendors that want to stick with what they know rather than embracing change and innovation. “Some CROs are still going the old-fashioned way, taking over 40 days to create SDTM [Study Data Tabulation Model] datasets, and another 50 days or more to create another set,” she says. “We look to largely reduce that time by incorporating SAS Life Science Analytics Framework, which lets you load all standard macros at the time of setup and prepares metadata needed for data transformation. Once implemented, the time required to generate SDTMs for a standard study is around one week."

SAS tracks progress for each deliverable analysis, automates activities using process orchestration and supports collaboration for data management processes and workflows. While it’s still a work in progress for her young company, Goel explains to new clients, “Yes, you can integrate your EDC [Electronic Data Capture] system with SAS Life Science Analytics Framework so it’s a one-stop shop. You can quickly go back to EDC through SAS, look at your raw data, instantly raise queries, and it will help you clean the data.”

That “one-stop shop” allows expanded access to and collaboration with clinical data, including data from diverse sources and departments. With the solution’s role-based access, Gunvatta can control, for example, physicians’, statisticians’ and other users’ access and permissions.

“In the life sciences industry, when we do randomized trials, it’s a big thing to control blinded versus unblinded,” Goel says. “SAS Life Science Analytics Framework gives you the capability to do the workflows right. You don’t have to undertake the extra effort to give and remove access to specific drives, folders and workspaces. Everybody is looking into one integrated and streamlined system. Everything is there in one place, accessible in real time.”

Delivering the power of analytics in the cloud

As a cloud-based statistical computing and analytics environment, SAS Life Science Analytics Framework includes embedded analytic tools, support for data standards and optional integrated analytic applications.

Goel observed more Gunvatta clients wanting cloud-based systems so they can better secure data and control access.

“The biggest advantage of SAS Life Science Analytics Framework is that the analytics platform is cloud-based,” Goel says. “I feel like SAS is way ahead of the current analytics software market. Having a cloud-based platform, you can work from anywhere. You can carry your laptop, even a loaner laptop, and still connect to SAS, so your work doesn’t stop. Obviously, the security really helps.”

The Gunvatta team, which had already set up a Microsoft Tenant, told SAS they wanted connectivity with Microsoft Azure so they could easily write data back and forth to the cloud. “It’s a seamless integration on the front end,” Goel says, which improves efficiency and reduces errors in data aggregation and preparation.

“When we receive data in Azure Blob Storage, SAS code connects to the Blob via Java that enables R/W capability directly,” Goel says. “When my clients want to share the data, they want to see as minimal human interaction possible, to minimize human error in the process of moving data across different folders through the complete life cycle of the CRO work. SAS Life Science Analytics Framework offers and enables a streamlined and seamless process to achieve this vision.”

Her experience with other analytics framework environments prior to SAS was one of limitations and security gaps, making it difficult to collaborate with data, share processes across the environment and support compliance.

“One of the biggest drawbacks was to have multiple sessions and multiple users running simultaneously,” Goel says. “But in SAS Life Science Analytics Framework, you can have multiple sessions running, so your work doesn’t stop.”

Ease of use adds to efficiency

Now Gunvatta’s team members – some recently hired after graduate school – can develop custom aggregate statistics using interactive visualizations that streamline data and monitor compliance. “I only had to give the graduates one presentation on SAS Life Science Analytics Framework, and they picked it up very quickly,” Goel says.

Having analytics tools embedded within SAS Life Science Analytics Framework means you can easily sort the analytics and see the summary statistics. “As a data person, you want to see what’s going on,” Goel says. “You can right-click and look for a subject or value. Those things really help when you’re getting the look, touch and feel of the data. Creating folders, creating links back to your shared drive if you want, everything is easy.”

For Gunvatta, spending less time on execution means having more time to spend on planning to ensure clients receive the quality work Gunvatta literally stands for. And just as Gunvatta means “quality,” Goel says the term she associates with SAS is “innovative.”

“Whether you know programming or not, you know SAS,” Goel says. “The first question any new customer asks us is, ‘What capabilities do you have, and what services do you provide?’ Then the next question is, ‘Do you have SAS?’ SAS adds value for the company, and because we have SAS Life Science Analytics Framework, we are at least one step ahead of other CROs that don’t.”