AETIOL™
THE SOURCE OF CLINICAL INTELLIGENCE

Aetiol™ is New web-based software Solutions for Pharmaceuticals and CRO Applications,Providing End to End Partnership

The most successful clinical trials begin and end with the highest quality, clean data. Data that is collected in the most streamlined and efficient way possible. An Electronic Data Capture (EDC) & Pharmaceuticals Marketing Surveillance System (PMS) is a computerized system designed for the collection of trial data in an electronic format for use in human clinical trials and Marketing Surveillance for Pharmaceutical companies. JGS Clinical trial studies are accomplished with the best clinical trial software. Our development is in progress to truly integrated Clinical solution that seamlessly combines EDC & CTMS and Safety into a single system, cutting costs and giving you control over your entire study. Unlike other systems that attempt to force completely unrelated systems to work together, JGS is developing Aetiol™ as a truly integrated system whose parts work effectively as a whole. Aetiol™ helps you to see everything that’s happening with your study in real time, at all times. This unmatched level of control helps you to make mid-study changes, contain costs, improve safety and increase ROI.

Aetiol™ provides the fastest start up, rapid database lock, and more rapid FDA submissions, resulting in a greater ROI. Aetiol™ features cross-panel edit checks that fire instantly upon data entry, eliminating trial delays and need for time consuming server calls, making it easier for your users to move through their data entry.

Clinical Trail:

Clinical trials constitute the single most expensive component of the entire drug development process. In particular, clinical trial operations represent one of the most resource-intensive areas within a biopharmaceutical company and often involve tedious, manual processes for collecting, aggregating and rationalizing information from a wide variety of data sources.

A DMS (Data Management System) yields immediate efficiencies and cost savings for clinical operations. By providing a single, centralized system to orchestrate operational and administrative activities, a DMS allows biopharmaceutical companies and CROs to intelligently manage the complexities of clinical trials. Instead of relying on disparate “islands” of information, often in direct conflict with each other, DMS users benefit from sharing consistent trial data across the entire enterprise. This allows the sponsor organization to streamline processes, appropriately respond to current statuses and proactively manage their trials

Pharma Marketing Surveillance:

The practice of monitoring the safety of a pharmaceutical drug or medical device before or after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose - meaning that they normally do not have other medical conditions which may exist in the general population – Pre and Post marketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.

Industries

  • Clinical Research Organizations (CRO)
  • Pharmaceuticals
  • Medical Devices Industry
  • Healthcare Industry

Aetiol™ Advantage

Key Objectives & Value Chain of Aetiol™ Application Services

  • Pre-Clinical & Clinical Trial Software Services
  • Pre/Post Marketing Surveillance Software Services
  • Pharma Sales & Marketing Distribution Software Services

Why Aetiol™?

Aetiol™ from Jade Global

  • High data security
  • Elastic database structure
  • Easy navigation
  • Simple data verification system
  • Comprehensive report system

Navigation

  • Different homepages, designed to be simple for site staff, sponsor and CRAs to use
  • Easy navigation from one page to another
  • Easy understand information layout
  • Screens built to mirror a paper CRF, although can be customised with different backgrounds, logos, styles and Data Entry instructions.

Data Protection

  • CRF data uploads to central server on a per page basis
  • 128-bit data encryption
  • Data stored on server - no data is stored on Site PCs
  • Customisable access levels
  • Individual user accounts
  • Detailed audit trails

Data verification

  • Automatic query generation
  • Data verification on input – abnormal value entered.
  • Standartised queries
  • If data is corrected, query is automatic approved as correct

Database structure

  • The capability to develop a library of sponsor specific CRF pages creates efficiencies when processing multiple projects
  • Flexible data collection, as well as sponsor defined naming conventions
  • Fast new studies implementation

Report system

  • Real-time project management and monitoring
  • Standard metrics combine with our design flexibility to create any sponsor defined reports
  • Clinical data exports can be facilitated in a variety of formats, such as Excel

Advantage of Aetiol™ Suite

Aetiol™ is adherent to 21 CFR Part 11 and Provides study design tools, data collection and sophisticated electronic CRFs, data quality management, integrated SAE reporting, and standard reporting. Aetiol™ supports project from small Phase-I Studies to large Phase – II/III/IV Studies.

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