System Features

Our datasets are in compliance with the FDA’s required CDISC SDTM standards.

The system developed in full compliance with the global standards for clinical trials, such as ICH GCP, FDA 21 CFR part 11, and Good Clinical Data Management Practices guidelines.

We provide a few preconfigured roles according to traditional clinical trials requirements: Administrator, Project Manager, Sponsor View Only, CRA, Exam Reviewer, Site User, etc.

Undoubtedly, the roles may be edited at any time according to your internal procedures and/or Study requirements.

You may want to manage as much studies as you need. For each of them you will be able to setup the team, add and compose sites, manage sites' equipment, manage Study procedures and eCOA/ePRO, setup exams’ review requirements, add reviewers - everything is clear and raising by a few clicks.

Study setup may be completed even within a few minutes without any coding!

You will have the easy and flexible tool for procedures setup and management. You will be even able to create the procedures plan with conditional jumps between procedures/visits.

As soon as setup is performed, you will have the plan of patients’ visits with expected procedures and eCOA/ePRO.

Then system will expect data capture according that plan, and you will have dashboard and ongoing reports to check the progress.

Data will be anonymized BEFORE the uploading to neoTrial. We do not have patients' personal data in the cloud to be compliant with all privacy requirements.

Personal data in the DICOM files will be replaced by Study related information, like Study ID, Patient ID, Visit ID, Visit Date, etc.

Images and/or other exams are to be reviewed by the independent reviewer(s) through the study.

Reviewers are able to write formatted reports inside the neoTrial, insert images, attach documents, sign it, share it.

The system is ready for collaborated review if required.

The system has a build in RECIST tracking and evaluation tool.

It is able to track the response automatically and alert in case of any issues - disease progression or any errors.

RECIST tracking on Study level is available for further analysis or export.

We offer you the self-sufficient and very convenient tool for construction any types of eCOA/ePRO including eConsent, eDiary, eQuestionnaire, AE Diary.

Among other things, it supports branch questionnaires (with skipping or vice versa showing questions depending on response on other questions).

Also, you'll have amazing questionnaires' translation tool.

Something is going in a wrong way? Just manage every error with the convenient (finally yeah!) query tool.

You will be able to insert images into the text of query, attach files and use text formatting.

Every action inside the system will be recorded into the Audit History with all the details - who, when, what have been changed.

neoTrial is able to store both DICOM and non-DICOM objects.

Just upload any clinical data you wish, and the system will process them for proper storage and retrieval.

The strong encryption for all stored data is used.

We use build in OHIF Web Viewer with GPU-accelerated image rendering and multi-threaded image decoding. It supports the multi-modal image fusion, the multi-planar reformatting, and more.

Thanks to asynchronous images loading and smart cache processing, data are loading to the viewer at lightning speed.