SAE Handling

The Most Intuitive EDC Suite on the Market

SAE Reporting Through SafetyLink

When a patient in a clinical study experiences a Serious Adverse Event (SAE), there is nothing more frustrating for the site than to be asked to resupply information that is already in the EDC system. Providing the event details again, the patient demographics, the lab results and a potentially long list of concomitant medications, represents unnecessary and duplicative work. TrialMaster solves this problem by providing mechanisms to detect an SAE and transmit the data to the clinical safety team in the industry-standard E2B format, obviating the need for site personnel to reenter the data. This digital transmission covers the event(s) in the safety case, plus all related information, and the case may be versioned over time as the source data changes.

The SAE information is automatically selected based on a mapping from the source data that is specified during study design. No programming is required. Furthermore, this means that future study designs may reuse the same mapping, which significantly reduces the setup time. This mapping reuse does a “best fit” analysis between the source study and the target study. For example, if the original study collected AE start time but the new study doesn’t, the mapping to the E2B start time element is nulled out in the new study. The designer may either leave this null value in place, or inspect a “variables not mapped” report and remap the variable to a different item in the study.

Your onsite clinical research team has one main job — caring for patients.

The TrialMaster Electronic Data Capture (EDC) solution makes it easier for doctors, nurses and other medical professionals to enter and manage their clinical trial data, thereby freeing up the maximum amount of time to care for patients. This ease of use for investigative sites, coupled with state-of-the-art risk-based monitoring (RBM) and analytical tools, means that life science companies can shorten the time to market for essential life-saving treatments.

Anju Software provides leading, strategic eClinical solutions for clinical trials around the globe.

Anju is dedicated to the process of enhancing a patient’s quality of life by reducing the time to market of essential life-saving treatments.

Pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers partner with Anju to maximize the value of their clinical research investments and to develop safe and effective healthcare treatments for patients.


The Most Intuitive EDC Suite on the Market

Featuring superior usability and flexibility, TrialMaster® is the EDC solution for Phase I – IV clinical trials



Proactive eSource and Early Phase Site Automation Solution

Bedside Data Collection (BDC) provides an automated solution to paper-based processes.


RTSM Master

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AutoEncoder is a modern and sophisticated tool for consistent and accurate coding out of the box.


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CTMS Master

Clinical Trial Management System

CTMS is designed to help sponsors and CROs overcome the technical challenges associated with managing clinical trials.


BioStats TLF

SAS based Report Software – FDA Submission capable

BioStats TLF (Tables, Listings and Figures) is a statistical authoring tool for creating the highest quality safety and efficacy tables, listings and patient profiles.


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