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David Kelleher, CEO4G Clinical addresses these challenges in several ways, one of the most core of which is simplification. The core innovation of 4G Clinical is the notion of creating a very high quality RTSM specification document, using a smart editor and natural language processing capabilities to ensure the spec is as perfect as possible. With a perfect RTSM specification, there should be no necessity to program a system. “All of the logic required to build a system must – by definition! – be present in the spec document,” says Ed Tourtellotte, 4G Clinical CTO. If the spec document is solid enough, it can “be” the program. “As far as we know, nothing like this has been attempted before in any industry, and we are thrilled to be progressing the idea,” he adds.
4G will offer other innovations as well, especially around forecasting where for the first time complex “traditional” IRT/RTSM resupply algorithms and parameters will be replaced with a built in self-forecaster controlled by little more than risk dials. “We take the complexity away, and replace it with business decisions that anyone can understand.”
We take the complexity away, and replace it with business decisions that anyone can understand
Eclinical trends tend to rise and fall; one trend that is relevant is using a truly modern technology stack. While a big chunk of the world is still building large enterprise deployments in either Java or Microsoft technologies, many of the most innovative and disruptive companies in the world have moved on. “The cloud is here, and it’s real. We’re taking advantage of that,” informs Tourtellotte.
“At this point, we are different in a number of ways,” says Kelleher. He goes on to say, “Our technology will be dramatically different than any other entity in the market and our maniacal focus on service quality and the sponsor experience will absolutely set us apart.”The firm also intends to employ variable billing and pricing models that reward performance instead of effort.
“Incredibly, our system is neither complete nor on the market yet,” extols Kelleher. Nevertheless, the firm has a significant group of pharmaceutical companies attending its first annual customer (“pre-customer”) event in 2016.
A few years from now, the company’s RTSM vision will be fully realized and will be ascendant in the market. At this point, the company will seek to expand outward along the eclinical spectrum, or possibly, even down the clinical supply spectrum towards manufacturing, if the opportunity presents itself. “Our vision and our approach is resonating in the industry; now we must deliver it,” concludes Kelleher.
Company
4G Clinical
Management
David Kelleher, CEO
Description
Delivers validated, easily extended RTSM capabilities faster than anyone in the world
Collaborative Approach: Precision in Design through Thorough Peer Review
The success of translating clinical trial protocols into the design of the RTSM system hinges on partnerships and collaboration. Open communication between the study team and the RTSM partner facilitates a design approach and review process that supports an iterative cycle. This collaborative effort during the design phase, including rigorous peer review, subjects trial designs to scrutiny from diverse perspectives. This process allows the technology vendor to offer best practice solutions based on collective experience. The outcome is a robust foundation that fosters innovation, identifies potential blind spots, and instills confidence in the final design. The collaboration extends beyond the design phase, ensuring alignment among sponsors, sites, and vendors throughout the study duration.
Designer Experience: Going Beyond Compliance with a Problem-Solving Mindset
A nuanced consideration of each trial is essential, and the collaboration with an experienced designer is a key differentiator when selecting a technology partner. Accomplished system designers, well-versed in protocol design, trial/therapeutic requirements, regulatory standards, and RTSM technology, ease the navigation of complex trial design implementation. The partnership with Sponsor subject matter experts enhances the review of study requirements, ensuring a user-friendly system trusted by clinical sites to guide patients through transformative clinical trials. Rather than treating protocols as rigid templates, experience provides a flexible approach, balancing various factors into systems that are both user-friendly and trusted by sites.
Sandbox Tool: Enhancing Understanding Before Commitment
Given the unique considerations of each trial, a comprehensive understanding of the RTSM system's features and end-user options should go beyond specification documents. A study-specific sandbox environment supports Sponsor understanding of the system and the implemented design. This hands-on exploration tool translates complex trial specifications into an interactive format, allowing stakeholders to address ambiguities and achieve consensus before finalizing the trial design.
Robust Test Strategy: Identifying and Mitigating Risks
After the collaborative and hands-on design approach, the RTSM design undergoes rigorous assessment against expectations and testing. An experience-driven clinical trial design prioritizes the development of a robust test strategy. This plan for internal testing aims to identify and address key risk areas, minimizing disruptions during the actual trial. Drawing from experience, the testing team strategically tests the trial design in a controlled environment, enhancing the overall resilience of the trial design and contributing to the seamless execution of the study.
Support for UAT: Ensuring Full Approval Before Deployment
After the implementation and rigorous testing of the trial design, the Sponsor evaluates the RTSM system through user acceptance testing (UAT). Experience-driven RTSM design ensures that the system aligns seamlessly with the needs and expectations of the study team. Utilizing the previously used sandbox for UAT provides a familiar platform for the Sponsor, allowing for a more robust and directed UAT experience. Active support during UAT enables experienced designers to collaborate with the Sponsor and assessors, addressing concerns and suggestions to ensure technical approval and enthusiastic endorsement by end-users.
Post Go-Live Support: Sustaining Success Beyond Implementation
In the post go-live phase of a clinical trial, ongoing support is critical for sustained success. Effective maintenance oversight, facilitated through reporting, alerts, and notifications, meets the individual needs of end-users. Utilizing the technology vendor as an extension of the study team encourages collaboration to identify and address areas of risk proactively. Continuous and open communication establishes a partnership for the overall success of the trial. Comprehensive study change and amendment support, informed by RTSM expertise, should be considered when choosing an RTSM vendor. Post go-live support goes beyond troubleshooting, fostering a culture of continuous improvement based on insights from monitoring and assessments, ensuring strategic adaptations for future challenges. This holistic approach, guided by experience, ensures that each clinical trial remains a beacon of innovation and patient-centric care.