Your partner for Dx compliance in translational research

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Leading Clinical Expertise in IVD and CDx Development

Helping your therapies reach their target.

We guide our clients through every phase of their IVD development and CDx studies. With the experience of conducting over 500 monitoring site visits, we integrate Dx and lab insights into our tailored protocols, ensuring data collection and compliance meets regulatory standards.

The EU IVDR landscape is rapidly evolving, elevating the importance of robust clinical evidence.

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Our team is here to simplify the complexities, from SOTA (state of the art) definition to in clinical evaluation studies, ensuring a direct path to evidence-based submissions.

Clinical Operations: Steering Your Studies with Precision

Designing and initiating a clinical study demands both meticulous planning and subject matter expertise.

At ARC, we’re immersed in the complexities of IVD and CDx studies. Our global network of experienced Clinical Research Associates, possess thorough knowledge of local clinical trial regulations and global GCP standards. From pinpointing strategic study sites to handling crucial documents and adeptly guiding through ethics submissions, ARC is with you every step.

Our precise approach ensures prompt site activations and strict compliance with GCP and local regulations.

ARC Clinical Operations offers:

Experienced Clinical Research Associates familiar with both global and local clinical trial regulations and GCP standards.
Strategic identification and setup of study sites tailored to your project's needs.
Deployment of our essential document toolkit for streamlined documentation and data control.
Comprehensive guidance through the ethics submission process, whether assisting investigators or taking the lead.
Development of risk-based monitoring plans aligned with regulatory requirements.
Conducting pre-site qualification visits and site initiation visits to help ensure timely site activations, all adhering strictly to GCP and local regulations.
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Site Monitoring: Robust Oversight for Readiness

Site monitoring is vital for maintaining study and data integrity .

With our team’s global and in-country expertise knowledge, we can navigate the clinical and regulatory requirements. This ensures studies are conducted to the highest standards, and the data and documentation generated is robust under regulatory submission and review.

Our Site Monitoring focus encompasses:

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Clinical Affairs: Ensuring Comprehensive Clinical Evidence

Clinical evidence is crucial for generating the performance evaluation documentation for in vitro diagnostic medical device.

However, creating strong evidence can be challenging, especially with increasing oversight from regulators around the world. At ARC, we know how vital this step is. We perform clinical evaluations and studies with clear precision and strict ethical standards. This ensures your evidence is trustworthy and meets all regulatory requirements.

ARC Clinical Affairs emphasises:

Crafting strong and clear clinical evidence for in vitro diagnostic medical devices.
Understanding the increasing scrutiny from global regulators to prepare solid submissions.
Conducting clinical evaluations with the highest ethical standards.
Implementing compliant studies that contribute to successful regulatory submissions.
Ensuring that all evidence and studies meet the evolving requirements of regulatory authorities worldwide.
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Choose ARC Clinical for a partnership that understands and prioritises your vision.

  • Expertise and Integrity: Our seasoned IVD and CDx medical device Clinical Research Associates prioritise patient safety, data accuracy, and regulatory compliance.
  • Dedication to Your Success: Every decision and action we take is carefully aligned with your objectives.

Biostatistics: Bringing together clinical data to drive best in class regulatory compliance

Ensuring regulatory compliance through accurate data interpretation is essential.

Our biostatistics team uses advanced analytics for insights from clinical investigations, performance studies, and electronic health records, all pivotal to a solid regulatory strategy.

With the help of a proprietary platform, we help you spot potential challenges early in the clinical development phase. Collaborating with sponsors and manufacturers, we develop a Statistical Analysis Plan (SAP) aligned with both the investigational device’s objectives and regulatory compliance needs. In engagements with global regulators, our regulatory medical writing expertise ensures a clear presentation of the statistical foundation supporting the device’s clinical application.

Lean on ARC Regulatory for focused biostatistics solutions:

Specialising in extracting meaningful insights from clinical investigations, performance studies, and electronic health records.
With our proprietary platform, we identify potential obstacles in clinical development plans, ensuring alignment with a regulatory strategy.
Collaborating with sponsors and manufacturers to craft an SAP that mirrors the device's performance goals.
Assisting clients in regulator meetings, emphasising the statistical rationale crucial for the device's clinical performance.
Through detailed regulatory medical writing, our protocols focus on optimal participant recruitment and retention.
Our strategic approaches guarantee that study data upholds and promotes the designated objectives and endpoints.
Guidance geared towards a seamless product introduction, with regulatory compliance at the forefront.
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Through advanced biostatistics, we ensure your diagnostic solutions meet the highest standards of data integrity and regulatory compliance.

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Get in touch with our expert team today