Sina Adibi, CEO & President
Clinical trials, indispensable when testing the safety and effectiveness of drugs and devices, involve a massive volume of diverse data sources. By one estimate, 40+ data sources and healthcare point-solutions come into play during the course of a typical clinical trial. From medical devices and wearables to data management tools, the advent of innumerable medical instruments and EHRs in the pharma industry has led to a data deluge that outstrips the capabilities of traditional clinical trial software tools. Surprisingly, data managers have found very little of these data volumes effective in operational optimization in reducing the cost and the time it takes to introduce a new drug to market.
Independent vendors are on the rise providing superior solutions for each individual aspect of this eco-system, from medical devices to data management tools. An unfortunate consequence of this multi-vendor environment is a massive fragmentation of data and a pandemic “silo’ing” of vital information.
To liberate the data trapped in various silos to accelerate clinical trials, New Jersey-based Adaptive Clinical Systems built from the ground up the Adaptive eClinical Bus® as the first true interoperability platform. “It is a cloud-based iPaaS, specifically engineered to work with the most popular eClinical systems,” explains Sina Adibi, president and CEO of Adaptive Clinical Systems. CTMS, eCOA, EDC, Medical Imaging, IRT, and analytical/ data visualization are some of the many systems with which the service integrates, proving that it can be beneficial for all stake holders in a typical clinical trial.
In conjunction with its integral Adaptive Rules Engine, the eClinicalBus allows for the real-time exchange of data across disparate systems from different eClinical vendors. The modular architecture enables a rapid, user-friendly setup. Its high level of component reuse helps COOs to codify operational processes and to utilize them again as canned procedures leveraging the eClinical Bus’ drag-and-drop interface.
With a flexible iPaaS architecture, a client’s clinical know-how is modified in the context of each individual drug development cycle. Once the company, as part of its services, establishes the workflow and data transfer rules through the eClinical Bus, Adaptive Clinical’s knowledgeable staff performs all necessary compliance related testing and certification. After the changes have been applied, the entire Adaptive eClinical Bus framework is recertified on an ongoing basis, which is an added advantage for CIOs.
As there can be uncertainties during the drug development lifecycle, the pay-as-you-go business model allows for a predictable cost structure for CFOs that want to utilize the Adaptive eClinical Bus. Clients need not be concerned about a significant capital investment upfront.
“Our partners have reinforced our market value in that they rely on us to deliver a cohesive solution to their important customers,” says Adibi, who has over 25 years of experience in healthcare and life sciences informatics and business process outsourcing. The company’s messaging has resonated well with CROs and specialty companies like Core Laboratories where improving on their data quality and reliability through interoperability have been top of mind for the data managers. In the ever-evolving pharma industry, Adaptive Clinical has benefitted from staying nimble. As pioneers of cloud-based electronic data capture, the company leveraged that to offer controlled medical vocabularies in an open-source model, followed by providing true interoperability with EMRs and EHRs.
“In the coming months, we are finalizing our 2019 go-to-market strategy leveraging new channels and addressing the pain points and needs of our constituency,” says Adibi. As the established vendor of record for attaining true interoperability, the company will expand its partners’ portfolio through establishing strategic relationships with new and emerging EHRs/ EMRs, eClinical vendors, as well as manufacturers of medical devices and medical monitoring wearables. Adaptive Clinical will continue to participate and work closely with industry-wide consortia and regulatory task forces to promote and establish interoperability as a requirement for drug discovery.