About CLINIONTM

ClinionTM is a clinical trial solution, which is uniquely focused on delivering superior user experience..Its advanced Electronic Data Capture (EDC) features help streamline the entire Clinical study process starting from study design all the way to data capture, medical coding and data management.

ClinionTM provides a fully featured, 21 CFR part 11 compliant EDC solution, giving both investigators and monitors a powerful yet easy-to-use environment for data entry and monitoring. ClinionTM supports all the steps of the clinical trial process from translation of the clinical trial protocol to the consolidation of all collected trial data, ready for reporting and analysis. It is available online and can be securely accessed from anywhere by authorized users.

ClinionTM

Highlights
21 CFR Part 11 Validated
EDC & Paper Studies
eCRF Designer with Global Libraries
Document Repository
SDTM Compliant
Medical Coding & Multilingual CRFs
Discrepancy Management
Cloud Based SaaS – Pay per use model

ClinionTM

Competencies
  • On-Demand, Web based EDC & Paper Based Trials
  • 21 CRF Part 11 Compliant
  • Intuitive Data Capture features
  • High sytem scalability [Multi site, Multi User Trials]
  • Paper Trial Module
  • Easy Study CRF design and Edit Checks setup
  • Customized Reporting and Dashboards
  • Multiple formats for Data Extraction
  • Medical coding using Standard Medical Dictionaries
  • Ad-hoc Data Extraction
  • Multi-lingual including international languages
  • Global Libraries with re-usable items, panels & pages
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8

FDA Approved Studies

82

Clinical Trials

168

Public Health Studies

21

Clients

16

Therapeutic Areas

ClinionTM Features

Idea Research Solution

eCRF Design

  • Manage multiple studies
  • Drag n Drop eCRF Designer
  • Edit Checks Configuration
  • Global Library
  • Study Manager
  • Staging & Production Instances

EDC & Paper Based Studies

  • Replicates Paper CRF
  • Source Data and Investigator Verification (SDV & IV)
  • Notes & Attachments Visits
  • First Pass and Second Pass Entry
  • Comparison Reconciliation

Data Management

  • Graphical Dashboards
  • Discrepancy Management
  • Medical Coding
  • Data Loader
  • Ad hoc Data Extraction
  • Locks – Monitor, DM, Page, Visit & Study

Discrepancy Management

  • Configurable DCF Workflow
  • Auto Edit Checks
  • Manual Edit Checks
  • Open discrepancies visible in the subject dashboard.
  • Update/ Close Query

Medical Coding

  • Supports MedDRA and WHO-DD
  • Multiple versions can be maintained.
  • Auto & Interactive (manual) Coding
  • Dictionary version and license key linked to the study

Other Features

  • Multilingual eCRFs: Supports Indian & International languages
  • SDTM compliant
  • Dashboard extraction
  • High System Scalability (>200 sites/users per Trial)

Data Security & Integrity

Expertise
  • Clinion in securely hosted in Cloud
  • The database can be accessed only through the application
  • The application has very strict access controls in place
  • Data extraction has to be done through the application
  • All access keys are encrypted and stored in the database
  • Data transfer from client to server is using secure protocols
  • Data integrity is managed by system design which does not allow deletion of any data in the system and logs all changes and access
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Therapeutic

Expertise

ClinionTM has been deployed for a large number of Phase I - Phase IV studies. ClinionTM has been deployed for FDA, EU, Israel & DCGI regulatory studies.The major therapeutic areas covered by ClinionTM are:

ClinionTM Vision

The search for perfection is an integral part of our corporate culture. We will be a leading data management solution provider by delivering compelling value propositions to the global healthcare industry. We put all our efforts, skill, expertise and dedication into developing a solution that perfectly meets your needs.

ClinionTM Mission

To reduce project risk and cost to Sponsor and to expedite the Clinical Trial Process with ClinionTM EDC solutions: Reduce project risk and improve quality with ClinionTM EDC solutions. Lower total cost of ownership with complete ClinionTM EDC solutions. Realize faster time to business value by leveraging ClinionTM by help of unique library of consulting assets and accelerators.

Quality Policy

ClinionTM is totally committed to building long term mutually beneficial relationships with our customers through delivery of quality products and services which not only meet but exceed their expectations. Our goal is to evolve into a customer-first, quality-first organization where every member of the organization works towards these goals.

Client Testimonials

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