IVD & CDx Clinical Operations

As the focus on robust clinical evidence increases, the scale and complexity of clinical evaluations and clinical performance studies, necessary to support evidence-based in vitro diagnostic and companion in vitro diagnostic medical device submissions, has also increased.

  • ARC Regulatory’s team of highly experienced IVD and CDx IVD medical device Clinical Research Associates will work to ensure the protection of patient safety, the integrity of study data and compliance with local regulations
  • We have regionally and often locally-placed CRA’s that are local to investigational sites, with in-depth knowledge of local clinical trial regulations and global GCP, who can liaise with sponsors and clinical sites to develop monitoring schedules that fully meet with regulatory requirements.
  • In addition, regionally or locally placed CRA’s reduce the cost of sending company employees to investigator or testing sites in remote locations

Our Clinical Research group will help you to select and set up global study sites, deploy our essential documents tool-kit, develop data management plans and study binders, assist investigators with or lead ethics submissions and conduct detailed qualification and site initiation visits ahead of site activation, all in compliance with GCP and local regulations.

Global Site Monitoring

ARC Regulatory is a niche provider of Global Site Monitoring for in vitro diagnostic medical device, and Companion Diagnostic IVD medical device studies. We have conducted >300 site visits, developing considerable specialised knowledge, and are global leaders in the development of scientifically sound IVD clinical performance study plans and protocols that yield robust clinical data for regulatory submissions.

Our regional or in-country CRA’s, whose in-depth knowledge of local clinical regulatory requirements assure robust study conduct, and data, suitable for global regulatory scrutiny:

  • Knowledge driven, detail-orientated approach to study conduct that provides confidence in the ongoing protection of study participants, data integrity and record keeping
  • We undertake close-out visits, data scrubs and part-11 compliant data transfer and archival
  • We provide ongoing Site Assessment of GCP, ensuring compliance with local regulations