IVD Services
ProCaliber Group offers in vitro diagnostic device (IVD) project services specifically tailored to the clinical laboratory and IVD industry, including technical support on developing clinical assays, converting investigations into diagnostic tests, optimizing test performance and stratify its use in specific environments, clinical validation, and trial for IVD products. Our team of experts work with the clients to ensure efficient and effective planning, execution, and monitoring of projects from start to finish.
01
Clinical Assay Development
We offer technical support and guidance to clients in the development of clinical assays. Our experienced consultants collaborate closely with clients to define assay requirements, optimize assay design and performance, select appropriate reagents and instruments, and establish standard operating procedures (SOPs) to ensure accurate and reliable test results.
02
Clinical Utility Assessment
We help clients assess the clinical utility and potential impact of their IVD products. Our consultants assist in designing and executing clinical utility studies, collecting and analyzing data on test effectiveness, patient outcomes, and healthcare economics, and providing evidence to support the adoption of the IVD test in clinical practice.
03
Conversion of Investigations to Diagnostic Tests
We assist clients in converting investigative assays into validated diagnostic tests suitable for clinical use. Our experts provide guidance on regulatory compliance, assay optimization, validation strategies, and documentation requirements to ensure a seamless transition from investigative to diagnostic testing.
04
Test Performance Optimization
We work closely with clients to optimize the performance of diagnostic tests, including sensitivity, specificity, precision, and accuracy. Our consultants provide expertise in assay troubleshooting, method validation, and process optimization to ensure the highest quality and reliability of test results.
05
Stratification of Test Use
We help clients identify and stratify the appropriate use of diagnostic tests in specific environments or patient populations. By considering factors such as clinical indications, test limitations, and patient demographics, we assist in developing targeted strategies for test utilization to maximize the clinical value and impact.
06
Clinical Validation and Trial Support
We provide comprehensive support for clinical validation studies and trials of IVD products. Our experts assist in study design, protocol development, subject recruitment, data collection, analysis, and interpretation. By ensuring robust clinical validation, we help clients demonstrate the clinical utility and effectiveness of their IVD products.
07
Project Management
Our team of experts collaborates closely with clients to develop project plans, establish timelines, allocate resources, and define project milestones. We provide ongoing project management and monitoring to ensure timely and successful completion of IVD projects.
At ProCaliber Group, we understand the critical importance of successful IVD development and implementation. Through our comprehensive IVD project services, we aim to empower our clients to bring innovative diagnostic tests to market, improve patient care, and make a positive impact on healthcare outcomes.