Datatrak Enterprise Cloud®

The cost-effective solution embedded with full functionality

Approximate 40-50 new drugs are approved on a year basis. The new development starts with searching for candidate substances and continues with various clinical trials. On average, it takes at least ten years for a new medicine and costs enormously to complete the journey from initial discovery to the marketplace.
We provide our EDC (Electronic Data Capture) for clinical studies, Fountayn(Pre Datatrak Enterprise Cloud). In the Electric Data Capture, all over the world 83 counties, more than 5,500 studies have been run and it is the most proven track record of EDC system. All the features required of EDC system are aggregated and included in one platform and user interface. Experience our services with Datatrak Enterprise Cloud to reduce costs and the efficiency in conducting clinical studies.

Intuitive User Interface
IWRS(Interactive Web Response System)
Query Management (Inquiries)
Coding
Local Lab Lookup
Import / Export
Double Data Capture (DDE)

Risk Based Monitoring (RBM)
Trial Design
eConsent/eCOA/PRO
Image Data Capture & Adjudication
CTMS
API

Intuitive User Interface

he Datatrak Enterprise Cloud is an easy to use EDC. Its alerts trigger on values entered prior to data submission, which archives to streamline the collection of adequate data.
The single-sign on capability allows a user to log in with a single ID and password to any of several related protocols which can be accessed from any devise and anywhere at any time.

IWRS (Interactive Web Response System)

The IWRS system gives you the ability to enroll patients, determine eligibility, randomize patients, manage study drug supplies and assign drugs into blinded clinical studies seamlessly. All randomization algorithms can be adopted within the platform. It can eliminate unessential integration over the EDC system.

Query Management (Inquiries)

he Query management capability allows the creation of queries to sites.

Coding

Each dictionary (WHO-DD, Iyakuhin(Japanese) Dictionary, MedDRA) is built-in the platform to code drugs, terms and etc. The synonym capability eliminates manual and automates manual coding activities. These dictionaries can be upgraded on a regular basis (Impact Analysis is run to excerpt difference information automatically).

Local Lab Lookup

Local Lab ranges can be managed to acquire a list of upper/lower values and units to determine “+ “or “-“.

Import / Export

The built-in import / export functionality allows the import and export the latest data on demand, which can be scheduled and automated by batch.

Double Data Capture (DDE)

CDMS capability adopts conventional paper-based clinical studies. Furthermore, we can support combined paper vs EDC based clinical studies. The built-in double data entry feature and automated-diff comparison tool can eliminate the collation of paper documents.

Risk Based Monitoring (RBM)

Maximize the benefits of your Risk-Based Monitoring strategy by utilizing out-of-the-box functionality for SDV, Data Review and eSignature. Powerful Reporting Capabilities give you site’s progresses. Set up your SDV plans based on risk assessments.

Trial Design

Trial Design streamlines the entire design-to-deployment process using a single tool. Simply configuring an excel spread sheet for your protocol and workflow and publishing it into the EDC will generate an entire study. Trial Design reduces time to deployment with our intuitive guide and the ability to apply mid-study changes quickly without any maintenance outage.

eConsent/ePRO/eCOA

Datatrak Direct is a built-in feature in Datatrak Enterprise Cloud. This cloud-based solution eConsent , ePRO and eCOA via internet. You can either utilize Datatrak Direct standalone or with Datatrak Enterprise Could. We offer a devise rental service with our partner company.

Image Data Capture & Adjudication

CTMS

Utilizing our robust data repositories, CTMS by Datatrak allows you to significantly optimize your workflow with insight driven data, ultimately empowering the users to accelerate the progress of trials. Data is perishable, and degrades over time, but with Datatrak, data is delivered proactively in real-time, ensuring the important decisions you make are reached with the most up-to-date information possible.

API

Exported data out of Datatrak Enterprise Cloud or other EDC systems can be up-to-dated linked through the API capability.