We are a global leader specializing in all phases of diagnostic research, including discovery, development and validation, and commercialization.
Clinical diagnostic studies are not the same as drug development studies. That’s why we work with our sponsors to run diagnostic studies in a way that optimizes efficiency and ensures a positive and rewarding study experience for physicians and their patients.
Our central monitoring approach and comprehensive knowledge of global regulatory environments allow us to speed up study timelines, focus on patient outcomes, and optimize global sample quality.
Specializing in clinical in-vitro diagnostic (IVD) and biomarker research.
Identifying high-volume real-world sites, ensuring robust sample integrity, and rapidly and seamlessly processing samples is critical to IVD and biomarker research. We rely on our local knowledge of cultures, beliefs, and regulatory environments, as well as our relationships with physicians around the world, to manage both large and small projects throughout the US, EU, and Asia Pacific regions. Our minimal risk research expertise ensures we can build a cost-effective, streamlined global operational approach.
Consolidating, automating, and reducing manual effort with a central monitoring approach.
Our unique central monitoring approach provides high-quality data that can be analyzed and acted upon at the sample, patient, site, and project level, ensuring high sample viability. With this operational model, we can maximize site participation, provide proactive support to potential high-volume and active sites, and use real-time information to focus on the most important thresholds, triggers, and trends to help our partners achieve their primary study objectives.
We’ve developed proven strategies to:
- Effectively identify and select sites where known patient populations exist
- Ensure rapid study start-up
- Streamline site management and monitoring
- Efficiently manage samples and logistics
- Collect high-quality data
Timely and seamless sample processing throughout the entire life of your study.
We believe a well-defined plan for sample collection, processing, and logistics is the only way to ensure high-quality study data. Our scientific experts use analytics to proactively follow the sample chain of custody processes to address issues early on, allowing us to see trends of non-viable samples for mitigation, and our teams are well-versed in import/export restrictions and local regulatory environments.See how a well-defined plan can reduce clinical diagnostic study costs.
Strategies for Accelerating Rare Disease Clinical Development
Rare disease trials differ from those in most other therapeutic areas because the indications are more complex and involve smaller patient…
Multi-Stakeholder Collaborations Can Minimize Barriers & Drive Rare Disease Clinical Programs to Better Patient Outcomes
Conducting clinical trials in rare diseases and advancing research pipelines requires a collaborative, multi-stakeholder approach. This process…
Clinical Trials in Children with Impaired Mental Capacity
Download this resource to learn how to conduct studies with patients who lack legal competence and the 4 ethical pillars of medical research.