All In Vitro and Molecular Diagnostics Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to both established and emerging diagnostic companies. The following case studies describe specific solutions that we have tailor-made for our diagnostics company clients.
A leader in molecular-based diagnostic tests and testing platforms sought assistance in developing its regulatory strategy for repositioning several analyte-specific reagents (ASRs). The company wanted a comprehensive regulatory perspective encompassing the various potential pathways for converting ASRs into diagnostic kits, as well as assistance in creating the pre-IDE information packages for each product. Working with the company’s internal resources, Beaufort completed this assignment, and, in addition, reviewed relevant literature and created a pre-IDE information package which included a high level clinical trial protocol for FDA review.
A subsidiary of a global molecular diagnostics company needed assistance developing an effective regulatory strategy for a drug-of-abuse assay. In-house clinical trial plans and previous 510(k) submissions had been rejected by the FDA. The company engaged Beaufort to redefine the intended use of the assay and provide guidance regarding effective interactions with FDA. Beaufort redefined the intended use to specify the results of the product and to enable FDA to focus on the potential positive uses of the product. After previous applications, literature, and data were reviewed, Beaufort redesigned a clinical trial protocol that would support the new intended use of the assay, providing appropriate focus on the actual functionality of the product. This done, the client was positioned to move forward in their plans for the product.
A division of a global molecular diagnostics company needed a regulatory strategy for a completely new technology. Division management had a clear plan for the scope of their product but lacked the regulatory expertise necessary to devise the most time and cost-effective approach for launching a new product. The company engaged Beaufort to develop a comprehensive regulatory strategy focusing on all aspects of the new technology, including targets and methodology. Beaufort provided a complete regulatory strategy that assessed the possible pathways for the product, as well as timelines, associated tasks, and costs for each type of submission. The client is using this strategy to plan its product development.
A leader in assay and sample technology development for tests used in the pharmaceutical and molecular diagnostics industries needed a regulatory strategy for its analyte-specific reagent (ASR) diagnostic kits. After identifying pathways to a Class II device classification, Beaufort prepared a strategic regulatory plan for the test kit, enabling the company to satisfy regulatory requirements in a cost-effective manner. Beaufort drafted a pre-IDE filing, including a clinical trial plan, and provided coaching to the client as they prepared for their pre-IDE meeting with the FDA. After successful meetings with FDA officials, the company relies on Beaufort for continued support as necessary, including assisting with pre-clinical and clinical trial activities.
The diagnostics division of a global top 15 pharmaceutical company engaged Beaufort to review their clinical trial protocol and to develop more cost-effective and efficient methods for managing their clinical trials. This was this division’s first use of an outside vendor to manage clinical trials in support of an FDA submission. Working closely with the client to obtain a full understanding of their processes, Beaufort created systems to manage the trials, combining the client’s operational procedures with our suggestions for system improvements. Clinical Trial Management included Site and Investigator Qualification, IRB submissions, Training, and Site Monitoring. Beaufort served as a conduit between the Sponsors and the clinical sites during the trial for communications and trouble-shooting to ensure necessary processes, documentation, and data collection were in compliance with GCPs.
A growing in vitro diagnostics company needed regulatory and clinical trial assistance for a 510(k) submission and a CLIA waiver. The company’s previous interactions with FDA highlighted a need for assistance in finalizing their clinical trial protocol, subsequent clinical trial management, and preparing for a pre-IDE meeting with FDA. Beaufort developed a comprehensive clinical trial protocol that provided the statistical power to support the intended uses. Beaufort prepared the company for interactions with FDA and meetings with the agency. Following these meetings, FDA supported the clinical plan which enabled the trials to move ahead and Beaufort located, qualified, and coordinated clinical trial sites for a highly time-sensitive trial.
A molecular diagnostics company developing proprietary nanotechnology to enable earlier detection and treatment of disease needed assistance conducting clinical trials in support of a 510(k) submission to FDA. Beaufort provided clinical trial management support, including clinical trial and regulatory document preparation, IRB submissions, and clinical trial monitoring support. This support enabled the company to make its first successful 510(k) submission to FDA.
A leading innovator in diagnostic and therapeutic products needed additional resources to manage three clinical trials in support of 510(k) submissions to FDA. The company’s products range from early detection and prevention of diseases to diagnosis, treatment, and treatment monitoring and this was the first time they had turned to outside resources to fill their needs. Beaufort developed a turn-key clinical trial management plan, beginning with site identification/qualification and essential document development for three separate clinical trials. In parallel, Beaufort performed a formal Risk Analysis Plan to ensure the project team was aware of the potential risks involved in performing three clinical trials within the very short timeframe required by the client. The plan identified potential risks, mitigating factors, and planned corrective actions if identified risks occurred. Beaufort initiated site identifications/qualifications and prepared the Project Operations Plan for the clinical trials.
A leader in molecular diagnostic innovation needed to review their Document Control System. Realizing they had insufficient internal resources, the Quality Assurance division sought assistance in transitioning from a paper-based document system to a software-based document control system. Beaufort performed an initial review of their system to identify any existing gaps. This effort included review of approximately 670 SOPs and 350 forms for content including obsolete references; document relevance; assignment of appropriate ownership/responsibility; and potential for SOP deletion, modification, or combination. In addition, Beaufort worked closely with functional areas to gain an understanding of the numerous processes and how they were potentially linked. This assignment led to a follow-on SOP project.
