Successfully navigate the complex process of bringing new treatments and therapies to market with Element. Our experienced team understands the unique needs of clinical trials - and our CLIA certified reference microbiology and molecular lab provides tailored, GCLP solutions that meet your specific requirements for bacterial and fungal phase I-IV clinical trials.
We offer a range of clinical trial support services for drug studies, including protocol development, regulatory support, site selection, project management, data management, and statistical analysis.
Trusted clinical trial support
Our team works collaboratively with you to ensure that your clinical trial runs smoothly and efficiently, while also maintaining the highest standards of quality and compliance.
Element receives clinical isolates and specimens referred from enrolled clinical trial patients. Our team then isolates, identifies, and performs various microbiology and molecular methods required for the clinical trial design, including susceptibility testing and whole genomic sequencing (WGS) for bacterial and fungal organisms. This data is then uploaded to the data management vendor and linked with patient clinical data, forming an essential part of your clinical trial data set. Accurate and reliable results contribute to the success of your clinical trial - you can trust Element to deliver high-quality testing and analysis services to meet your needs. Want to know more? Request more information.
Clinical trial support services
- Phenotypic mass-spectrometry (MALDI-TOF) and sequencing identification
- Reference broth microdilution, disk, and agar susceptibility testing
- WGS for identification of resistance genes, virulence factors, and epidemiological typing
- Clinical trial kit supply for smaller, US-based trials
- Microbiome analysis (16S and metagenomics)
- Long-term storage of clinical isolates
The Element advantage
With Element as your CLIA certified microbiology lab partner during bacterial and fungal phase I – IV clinical trials, you can expect comprehensive support, tailored solutions, and an unwavering commitment to compliance and quality. We'll work closely with you to understand your unique requirements and develop a customized plan that meets your specific goal, ensuring that your clinical trial runs smoothly and efficiently.
If you're looking for high-quality clinical trial support services that exceed your expectations, contact Element today. Our team is here to help you bring your treatments and therapies to market with confidence.
Drug Discovery and Development
Discover active drug candidates faster and accelerate time to market with Element's integrated CDMO services platform that supports the entire development lifecycle.
Molecular Studies and Testing Services
Element's CLIA certified reference microbiology lab molecular studies help you achieve research and clinical goals with accurate, reliable data.
Microbiome Testing and Analysis
From DNA sequencing to microbiome profiling, we offer a full range of microbiome analysis services tailored to your specific needs.
Expert Medical Writing Services
Effectively communicate research findings and clinical data. Our experienced medical writers offer manuscript writing, regulatory document prep, and more.