Benjamin Jackson, Co-founder, President & CEO
As waves of evolution take hold of the clinical data management arena, companies working to create and improve medical devices, pharmaceuticals, and biotechnology solutions are facing a variety of challenges. Expenses associated with the development and deployment of pharmaceuticals and devices are among the most rapidly growing concerns across the healthcare industry, and clinical research represents a substantial portion of these costs. For small- and mid-sized biotech, generics companies, phase I studies and CROs there is an increasing pressure to bring the cost of research and development down to ensure faster returns on investments and drive access to high-quality patient care. Quartesian, a clinical data technology firm, has met this challenge head on, delivering solutions to meet the unique requirements of these companies in order to meet the needs of an ever-changing clinical research landscape.
"High quality, fast, efficient clinical data at an affordable price should be the norm, not the exception. That’s our mantra, and that’s what we plan to continue delivering to our customers in the future"
Benjamin Jackson, Co-founder, President, and CEO of Quartesian explains, “The company is built for the current state of clinical data management and research, but we are also positioned well for the future changes in the industry. We offer state-of-the-art service to small- and mid-sized biotech, generics companies, phase I studies and CROs, enabling them to gain more from the revolution taking place in clinical management and trials.” The New Jersey-based company was founded in 2003 on the backs of four experienced principals who have a deep knowledge of the challenges that clinical trial sponsors are up against in today’s market. With the big pharma research model broken and patent life reached, companies find it difficult to find the best-fit solutions to generate a return on investments. Quartesian delivers high-quality technologies and processes to these companies, tailored to each customer’s unique trial and data management needs.
Affordable, State of the Art Solutions
The pressures placed on these companies require a solution that is customized with the best technology tools, which allow for effective clinical research in the digital age. Jackson states, “It has become harder to recruit participants, given the non-naive patient population, and protocols have become more complicated. With more drugs on the market, the focus has shifted to the therapeutic areas where treatments are most needed.” The traditional model is no longer effective with these evolutions taking place, and more bodies are chasing the same treatments which have changed how clinical trials are done.
Quartesian recognizes that customers whose clinical budgets are not as large as top tier pharma require an alternative to the big study models if they want to deliver results on time and within budget. To this end, the company offers a comprehensive suite of digital tools, backed by a commitment to understanding what their customers need in terms of processes and best practices.
We have worked for over 100 pharmaceutical, biotechnology, and medical device companies with 100 percent repeat business and no change orders
Each platform Quartesian offers operates with a driving philosophy of quality management, increased productivity, and reduced cost. Through its data management solution, the company offers tools to assist customers with paper CRF-based clinical studies, Electronic Data Capture (EDC) studies, and rescue studies, both paper CRF-based and eCRF. By integrating with a widely available, user-friendly data management system, Quartesian’s data management team works in line with study personnel to deliver quality, clean datasets, locked on or prior to the required deadline. Jackson explains, “We license two leading EDC technologies directly, and because of the volume we produce, we can offer customers savings on a specific license.” The company understands that most companies are not seeking out the most premium service, given its truncated needs. Quartesian is able to bring top of the line service solutions to the finite space without the exorbitant cost associated with the full technology package.
In addition to data management solutions, the company also has extensive experience in the statistical needs of clinical trials and research. The company’s biostatistics team works diligently to calculate sample sizes for a wide range of customer needs, including preclinical, phase I-III clinical studies, as well as observational or registry studies. Part of the solution Quartesian provides relates to the construction of statistical sections of studies to ensure compliance with overarching regulatory requirements, offering collaboration with study statisticians or acting as a statistical team on its own. Also, the company provides automation for quality assurance and quality control processes aligned with current standards, along with validation and parameter calculations to meet the specific study needs. Programming for CROs based on the unique demands of the market is also made available for customers that consistently face the challenges of ebbs and flows relating to recruiting and on boarding in a limited amount of time. Jackson states, “It isn’t just about writing the appropriate code—it’s about knowing the end point for the customer. Statistical expertise is in our DNA, and we power and design effective study models based on our extensive experience.” Following that trend, Quartesian provides expert medical writing through a blended approach that hones in on the end goal of the trial or study. While routine tasks are taken offshore to help reduce costs, onshore experts complete high-level reviews of the data and tie it together to convey the complete story in a simple, effective way.
One of the ways in which Quartesian stands out among its peers is its dedication to security and compliance through the clinical data and management space. All data is protected and compliant with up to date regulations, and the company follows a strict operating procedure for auditing any technology it licenses. With a full-time audit and compliance department, Quartesian has a well-managed and comprehensive clinical management system that allows for keen awareness of the functional protection of health information. Jackson explains, “We evaluate each vendor and complete an audit process either in-house or through a third party for reporting tools, analytics solutions, management systems, and EDC.” Customers know they can trust the level of security provided by Quartesian’s service solutions based on the integrity inherent to its vendor evaluations.
Delivering Integration, Speed, and Accuracy
Recently, Quartesian has had the opportunity to work with a CRO facing a variety of challenges in getting off the ground with a new study. The customer was having a hard time recruiting patients and finding a partner for clinical data services. The CRO had been an opinion leader in that space, understanding how to recruit as well as manage the site, but it was lacking a viable solution for controlling the data. Quartesian was able to integrate with the CRO partner to provide the clinical data tools necessary to complete the study under time constraints. As the expert data provider, the company was able to work directly with the CRO to meet the tight deadline, allowing the company to complete their first to file objective.
Quartesian’s ongoing success can be attributed to its dedicated team of employees and principals, all who work to be problem solvers in the industry. Jackson states, “We don’t just focus on technical skill, but also on effectiveness in communicating with customers and understanding their specific pain points. Every team member finds the means to fix these complex problems through innovation.” While a number of companies in the clinical research and data management environment try to develop lower cost solutions through offshore services, Quartesian shifts its attention away from per unit cost by empowering employees to go as far as they want or can within the organization. Jackson continues, “Our goal is to take state-of-the-art clinical data management technologies and train our people to use them as good as anyone in the world, and then build processes and models that represent the best practices for our customers.”
Over the last year, Quartesian has expanded rapidly on a global front, adding an office in Kiev to deliver its service solutions to customers in the region. The company plans to hire an additional 100 employees to continue its expansion geographically, and to support the upcoming release of its own EDC technology and capabilities. Jackson states, “We want to integrate strong tools that are out there for IRT and e-pro solutions, and we are working with premium technology partners to find the best-fit tools for customers.” Quartesian is also taking on opportunities for a site-less study with a CRO in the space, staying true to its vision that every clinical trial requires a customized solution. Jackson concludes, “High quality, fast, efficient clinical data at an affordable price should be the norm, not the exception. That’s our mantra, and that’s what we plan to continue delivering to our customers in the future.”