The Sirona Dx Research and Development team is technology agnostic and works closely with our pharma clients to select the most appropriate methods and platforms. Our team applies cutting-edge technologies to develop and validate high-complexity genomic assays.
Sirona Dx offers a variety of clinical trial services including assay development, customized reporting, trial site training, and investigator support. We undertake studies of various scale and scope ranging from Phase I to Phase IV clinical trials. We apply the highest level of control including 21 CFR part 11 (Federal Regulation for Electronic Records and Signatures) to obtain the most consistent and highest quality data.
The Sirona Dx 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 report designs and distribution capabilities.
The Sirnoa Dx Information Technology (IT) infrastructure has a fully validated data management system that complies with 21 CFR part 11 and 21 CFR part 58 regulations. Our laboratory maintains a comprehensive disaster recovery plan to ensure data security.
Our Laboratory will identify the best analytical approach for data interpretation. Our bioinformatics team has the skills, understanding and tools to help you successfully manage large NGS data sets. Whether contracted in conjunction with an NGS clinical trial project or as a stand-alone service, we can tailor our Bioinformatics Services to your project.