Your Clinical Trial Partner
Molecular Testing Labs offers a variety of clinical trial services comprised of protocol design, assay development, project management, trial site training, investigator support, customized reporting, and data management. We undertake studies of varied scale and scope ranging from Phase I to Phase IV clinical trials of high complexity molecular testing. Our clinical trial capabilities extend throughout each of our laboratories and services. Due to our diverse skill, we are able to offer an extensive portfolio of services including pharmacogenomics, targeted sequencing, custom SNP genotyping, NGS, high resolution immune profiling, infectious disease detection / genotyping, environmental analyses, and LC-MS/MS based assays.
Companion Diagnostics Capabilities
Current escalating costs of drug discovery, development and drug launch continue to concern the pharmaceutical sector. This has been compounded by the advent of personalized medicine and its associated demands for individualized products as well as the demise of the “blockbuster” model. In order to satisfy the demands afforded by this new paradigm, the next generation of drugs has to be safer and more efficacious and pharmaceutical companies must produce more genotype and/or phenotype-focused therapeutic agents. The development of Companion Diagnostics appears to offer a set of tools as well as relevant biological and clinical information that addresses many of the problems that the pharmaceutical companies must overcome. Our team has the experience and resources to take your custom LDT through a submission.
The Molecular team works closely with our clients to select the most appropriate reporting format to meet the needs of the sponsor, trial investigators, and regulators. We offer customized test report designs and distribution capabilities. Our project managers deliver the data reports on target and on time. Frequently, graphical displays and interpretation guidelines are required to ensure proper patient management and clear communication among sponsors and trial investigators.