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Ahmedabad, Gujarat, India business@primeservicescro.com

Diagnostics Expertise

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Diagnostics Expertise

Diagnostics play a critical role in disease prevention, early detection, monitoring, and personalized treatment. Our expertise ensures that diagnostic technologies from imaging systems and laboratory assays to molecular tests and digital health tools are evaluated with scientific precision, regulatory alignment, and patient focus.

With experience in diagnostics, companion diagnostics, biomarker validation, imaging modalities, and point-of-care testing, we help sponsors generate robust clinical evidence to support regulatory approval and widespread adoption.

Our comprehensive diagnostics research approach covers all diagnostic technologies and testing modalities. We focus on delivering evidence that supports improved diagnostic accuracy, faster results, and enhanced patient outcomes while ensuring compliance with international diagnostic research standards and regulatory requirements.

Our Deliveries

  • Comprehensive Clinical Trials Specialized studies for diagnostic devices, assays, biomarkers, and digital health tools
  • Regulatory Excellence Deep expertise in IVD and diagnostic-specific regulatory pathways (FDA, CE-IVD, IVDR)
  • Patient-Centric Research Ensuring accessibility, accuracy, and faster results for improved patient outcomes
  • Outcome-Driven Insights Evidence generation on sensitivity, specificity, predictive value, and real-world utility

Our Capabilities

  • Clinical Trial Services Study Design: Tailored diagnostic trial protocols with endpoints like accuracy, reproducibility, and predictive performance. Patient Recruitment: Engagement of appropriate populations across disease areas for representative sample testing. Site Management: Collaboration with laboratories, hospitals, and diagnostic centers for seamless trial execution.
  • Regulatory Compliance GCP & ISO Standards: Conducting trials under IVD-specific guidelines and global quality standards. Regulatory Submissions: Preparation of technical files, performance evaluation reports, and dossiers aligned with FDA, EMA, and IVDR requirements.
  • Patient-Centric Approach Accessible Solutions: Focus on tests that improve early detection, reduce diagnostic delays, and guide personalized treatment. Patient Experience: Designing studies that consider ease of sample collection, turnaround time, and patient convenience.
  • Research Insights Publications: Expert-authored white papers, case studies, and peer-reviewed articles on novel diagnostic technologies. Access to Journals: Latest insights from molecular diagnostics, imaging, AI-driven diagnostics, and laboratory medicine journals.