Expedites development and approval of studies of any size for Phase I-IV clinical trials and medical device companies

TrialMaster provides a dynamic monitoring capability whereby patients can be randomized to a particular monitoring level, with the randomization balance controlled by a site risk rating. The chosen monitoring level then determines which forms require SDV, providing a convenient task list of selected pages for the monitor. If necessary, the monitoring level can be manually over-ridden to provide a higher or lower level of SDV for that patient.

TrialMaster can be translated into any number of foreign languages. A user can select his or her desired language and the corresponding foreign language text is retrieved from a global translations database and displayed immediately. For example, a Japanese user and an English user could be working simultaneously on the same trial.

Capture risks and develop mitigation strategies based on Key Risk Indicators (KRIs). Risks are linked to KRIs and dashboards, and are monitored at a subject and site level. Mitigation strategies can be mapped to alerts and KRIs to ensure traceability.

The Custom Data Export Utility is a drag-and-drop tool allowing you to define export data domains, and then map and transfer the data collected to the export domains for statistical analysis (SAS datasets), while also mapping to industry standards such as CDISC and SDTM. Standard templates are available by default for all SDTM domains.

Reduce the need for reconciliation between your EDC and Safety system while also eliminating duplicate data entry effort for site staff with the Safety Link feature of TrialMaster. Site staff can enter a range of data, including serious adverse events, relevant medical history, concomitant medications, and dosing and lab test information from existing patient data and choose to send it to Safety. An E2B file will be created and with Anju’s adaptive clinical platform can be integrated with your own Safety system.

Lab data can easily be uploaded to TrialMaster, including images. Ranges can be defined in TrialBuilder for a lab test, including specifying the controlling variables such as the patient’s sex, age and visit date. When the site user enters lab data, TrialMaster looks up the appropriate range, flags the value as low, high or normal, and opens up a clinical significance prompt if the value is low or high.

Reduce regulatory risk, improve quality, and maintain compliance with real-time insights. When integrated with our RBQM Master’s eClinical application and its data visualization functionality, you can access your portfolio views of compounds or therapeutic areas across your organization. Site profiles integrate clinical and operational data that provide a comprehensive view of site performance. RBQM Master’s Subject Profiles give comprehensive and detailed views of subject data across domains, including visit information, safety data, medical history, vitals, imaging and core labs, and exposure to IP.

Patients can enter their data into the TrialMaster system screens, translated to their preferred language, providing a simple, unified environment and immediate data access for the sponsor and site personnel.

TrialMaster’s AutoEncoder provides coding against the MedDRA and WHODrug Global dictionaries, and includes such features as auto-coding, manual coding, review and approval. AutoEncoder can be integrated with TrialMaster or any external EDC or Safety system.

TrialMaster provides an intuitive interface for building flexible, simple or complex studies for Phase I – IV trials. Its TrialBuilder module includes user-friendly WYSIWYG CRF design and automatic Edit Check generation for rapid study design. Typical TrialMaster users can build studies in a fraction of the time it takes with other EDC solutions, significantly driving down operational costs.

TrialMaster’s mobile-enabled platform has the capability to perform the eConsent process directly within the EDC system from any location. Patients can enter their own data and create and launch video testimonials and documents from within an iCRF, complete assessments built to gauge understanding of their experiences, and provide an eSignature – all without the need for an additional eConsent platform.