Technological advances continue to move faster than the science for evaluating the benefits and risks of new products. FDA’s Center for Devices and Radiological Health (CDRH) is implementing strategic programs to streamline the medical device development and review process. This presentation provides an overview of FDA’s Regulatory Science Tools, an update on progress of qualification of Medical Device Development Tools and provides helpful resources and tips for finding these tools.

ISO 14155 "Clinical investigation of medical devices for human subjects — Good Clinical Practice" has been recently revised and has been substantially extended. This revision includes: Guidance for ethics committees (Annex G), the reinforcement of risk management (ISO 14971) throughout the process of a clinical investigation (Annex H), clarification of applicability of the requirements of standard to the different clinical development stages (Annex I), and the inclusion of guidance on clinical investigation audits (Annex J). The according impacts on design, conduct, recording, and reporting of clinical investigations will be presented.

The notified body certification submission process, particularly for the clinical documentation, is complex and challenging.  Based on experiences with vascular clinical evaluation (both MDD and MDR), gain valuable insight on common deficiencies found in applications, and best practices for submitting a file that is likely to proceed smoothly through the review process.

Regulators, patients, payers, and providers are increasingly requiring broader demonstrations of evidence across the medical product lifecycle often beyond what traditional clinical trials can provide. In this presentation, Deloitte will share its perspectives on the potential value, state of use and keys to success of adopting new technologies to enhance clinical trial and evidence generation effectiveness of medical technology in a changing regulatory environment.

A CTMS is the backbone of clinical trials management and assures that sponsors, CRO and SMO have their clinical study execution under control. All major deliveries with their corresponding milestones are planned and closely tracked. Join this presentation to get an insight why the “standalone” eTMF, where all essential documents for conducting clinical trials are stored, will disappear and be an integrated component of the CTMS in the future.

Regulators recognize the risk of cyberattacks, and cybersecurity is becoming imperative for manufacturers as well as healthcare organizations. Requirements for cybersecurity are divided into the process tasks (which includes a risk management- and post marked activities) and product related tasks (which includes implementation of cybersecurity controls and verification activities). In this talk we want to provide information on how develop medical device incorporating software or software as a medical device in compliance with cybersecurity requirements. We will touch on FDA requirements as well as European requirements defined in MDR/IVDR considering respective guidance documents from MDCG.

This presentation will outline the purpose of pre- and post-market studies and why multiple types are necessary. I will provide a comparison of requirements by study type and share how real-world data and experience (RWD/RWE) could be used in both pre- and post-market studies. This presentation will highlight a case study in embedding post-market studies in national registries.

Outsourcing strategy and vendor selection in a key component to effectively setting up and running a successful clinical program. As more clinical trial activities are outsourced to CROs and other third-party vendors it is important to utilize a rigorous vendor selection and management strategy, implement the right KPIs and metrics for success, and ensure effective oversight and risk mitigation.

Unlocking the potential of the next generation of clinical trials will require transformative change in how we approach collecting and managing clinical data. As we move beyond CRFs and embrace eSource, committing to collecting structured data will be vital. With structured data, data ontologies can both increase the usefulness of the data collected, and reveal previously-hidden insights, but only if we are willing to make the investment.

Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring. 

Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

Leading edge technologies are being developed incorporating data science alongside clinico-biological science. Current product development and clinical trials of these products require a more flexible and open framework for innovative data approaches. Key to this framework is cross functional engagement to define requirements and evaluate performance of both the analytical, clinico-biological and data sciences. Since innovation precedes adoption, it precedes a well guided and defined framework for execution. As innovators, we focus on how technology is re-defining the way we approach development and clinical performance evaluation of in vitro diagnostics coupled with AI to deliver needed advancements in specialty care. 

While cyber risk is not new, cybersecurity language in CTAs and remote monitoring agreements is.  Security incidents can impact multiple parties, creating mutuality of risk. This session will discuss sample cybersecurity language from research institutions and pitfalls for sponsors.   Hear about lessons learned from sponsor audits of their vendor agreements for compliance with CTA cybersecurity obligations.  Common gaps make sponsor CTA obligations heavier.  Learn about contract provisions that mitigate risk.

The number of registered clinical trials underway has increase significantly. Clinical administration costs are also rising as Clinical trial workers are doing manual tasks as remote trials add greater regulatory reporting complexity. Automation with robotic process automation (RPA) at the core, has emerged as a pathway to agility, accurate and transparency for today’s digitally forward providers. Clinical teams can now be empowered to perform the” higher valued-added work” of insights and risk mitigation, with the assurance that their “digital peers” can manage the redundant, manual, and repetitive work of data intake and administration. . This discussion and demonstration shares ways today’s modern clinical trial programs might achieve happier teams, better quality results with speed at scale.