Sirona Dx offers a variety of clinical trial services including assay development, customized reporting, trial site training, and investigator support. We undertake studies of varied 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 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.
Investigator and Trial Site Support
Sirona Dx is committed to exceed your expectations. We provide comprehensive services to investigator sites including custom sample collection kits, one-on-one counseling, training services, and protocol-specific support. In addition, our experienced project management team will answer questions throughout the life cycle of your clinical trial - from site initiation, testing, reporting, data transfer and interpretation. A designated team of CT specialists maintains a detailed ongoing knowledge of all aspects of the trial, from contract, protocol, statement of work, sample collection and shipping protocols to data reporting.
Sirona Dx offers educational programs during investigator meetings that include testing protocols, platform & methodologies, and data interpretation.
Data Management Program
The Sirona Dx Information Technology (IT) infrastructure has a fully validated data management system. The trials' data are 21 CFR part 11 as well as 21 CFR part 58 compliance. Our laboratory maintains comprehensive disaster recovery plans to ensure data security.