Clinical Affairs

Clinical evidence is critical in demonstrating the clinical performance of an in vitro diagnostic medical device. Compilation of adequate clinical performance evidence can often be one of the most challenging aspects of a regulatory submission, and is coming under continuous and increasing scrutiny by regulatory authorities worldwide.

Conducting clinical evaluations and/or clinical performance studies, in a compliant and ethical manner, is essential to ensuring a successful regulatory submission.

Compliance with global regulations increasingly requires robust clinical performance data. ARC Regulatory specialises in compiling in vitro medical device clinical data, and we can ensure that your Clinical Literature Reports meet global regulatory requirements. If necessary, we can develop a protocol to methodically search and evaluate journal articles to demonstrate clinical performance.

At ARC Regulatory, we:

  • Help you to understand and successfully leverage the commercial benefit of robust clinical evidence
  • Provide support from the start of the clinical validation phase, implementing and optimising clinical evidence strategies to streamline validation timelines
  • Develop and conduct Post-market Clinical Follow-up studies to meet regulatory requirements, as well as support and enhance product performance and risk-benefit claims

Clinical Strategy

In combination with our regulatory and clinical research business units, ARC Regulatory supports the development of clinical strategies, and ensures they are aligned with global regulatory and ethical requirements, supporting your global product positioning and market access objectives.

We integrate with development teams at the earliest possible stages of product development and incorporate key clinical performance evidence, including:

  • Development of user needs and clinical requirements
  • Market-specific clinical evidence requirements
  • Identification and leveraging of peer-reviewed scientific literature
  • Clinical site selection and set-up
  • Development of targeted clinical investigation endpoints

Clinical Protocol Development​

In collaboration with our biostatistics partners, we develop clinical investigation protocols and clinical performance plans that are scientifically sound, meet the needs of all stakeholders and yield clinical data that is robust, verifiable and demonstrates the study objectives.

  • Clinical protocol design that maximises the potential for recruitment and retention of study participants
  • Smart statistical planning and data modelling seeks to ensure that study data supports the objectives and endpoints
  • We work to deliver a successful and streamlined product launch to market

Post-Market Clinical Performance Follow-Up

Post-market clinical follow-up is an essential process that must be implemented to maintain compliance with regulatory requirements, and is becoming an area of increasing scrutiny for regulatory authorities worldwide. ARC Regulatory can assist with planning, conducting and monitoring post-market surveillance, including clinical follow-up studies and/or clinical literature reporting for in vitro diagnostic medical devices.

Post-market clinical performance studies may be required for the following reasons:

  • To monitor the residual risk of an in vitro diagnostic medical device that is currently on the market
  • For ongoing assessments of the performance and benefit of the medical device
  • To monitor clinical performance of the in vitro diagnostic medical device in a representative population
  • A new indication for use or clinical claim is being made
  • Your device has significant changes to design or labelling
  • The risk classification of the in vitro diagnostic medical device has changed
  • You have received feedback on your device, resulting in questions regarding clinical performance, safety or effectiveness

Device classification and regulatory requirements will define the most appropriate pathway to conduct a post-market clinical performance study or follow-up. Our clinical consulting team can help you clearly define the most appropriate methods.