Offshore OutSource Development Company in Software Development and IT Infrastructure Management in Hyderabad, INDIA

By: Quadone  09-12-2011
Keywords: Data Capture, Electronic Data Capture, Report Generator

Clinion - Clinical Trial Solutions™  

Clinion™ is a Clinical Trials software using an Electronic Data Capture (EDC) system designed to reduce the cycle time of Phase I through IV clinical trials. It enables pharmaceutical, biotechnology and medical device manufacturers to get their products to market faster by providing a fast and easy study set-up, data capture and reporting.

Clinion™ consists of a hybrid architecture allowing for data capture online or offline. It is a Client-Server configuration consisting of

  • Study Builder
  • Hybrid Client
  • Central Server
  • Report Generator

Clinion™ incorporates many of the features required for the conduct of Clinical Trials as per US FDA and ICH GCP guidelines and is being made fully complaint with these guidelines.

Clinion™
offers multiple benefits to companies conducting clinical trials:

  • Real-time monitoring of Trials
  • Real-time data availability
  • Increased protocol compliance
  • Faster database lock
  • Reduced costs because of shorter trial period and remote monitoring

Clinion™ is presently being used by some of India's top pharmaceuticals companies.

Study Builder
The Study Builder is a configurable, generic tool, using which any type of Clinical study can be built.

It consists of easy to use form builders, which can be used for study design, granting access to Investigators, uploading protocol information and eCRF creation. Validations and checks for greater protocol compliance can be assigned to each field in the protocol. Once the study has been built it can be published online or offline. The application also allows the Sponsor to configure as many studies as possible and deploy them concurrently.

Hybrid Client
The study can be set up online on the Internet or Offline at the study site. The eCRF comes with in-built validations and checks, which ensures that the data entered is validated and checked before being sent to the server.

The Offline Client is totally stand-alone and does not require to be connected to the Internet. A single client can handle more than one trial at the same time with separate user access for each trial.

Central Server
The synchronized data is sent to the central server, which checks the validity of the data and stores the same in a secure database on the server. The server is hosted on the internet where is it accessible to all trial personnel.

Report Generator
The Report Generator at the server automatically generates reports using a Report engine. The Sponsor as well as the Investigator can access the reports. However the Investigator can check the data for his center only.

The reports show the trial progress across the various sites by giving data on patients screened, recruited, visits, investigations etc. Output of the consolidated data of all the sites is available for the sponsor in a spreadsheet format, which can be directly used as data input for any standard statistical software like SAS, Epistat or SPSS.
Current Version 

Next Version
(Next 1 to 3 months)

 Next Version
(Within 6 months)
- Protocol & eCRF creation
- Validations
- Audit trails
- Security
- Authenticated login
- Role based access
- Time stamps
- Data capture & storage
- Secure data transfer
- Reports (in excel format)
- Software validation
- Data back up
 

- Online client
- Client side audit trail (Online)
- Documentation on security procedures
- Creation of additional users
- Complete log
- Printing audit trails
- Documentation on data retrieval
- Systems documentation

 

- Electronic signatures and digital certificates
- Double data entry
- Further enhancements

ROAD MAP

Some Statistics..

  • 10 trials completed
  • 1123 patients enrolled
  • 10 sites all over India
  • 8 Cities all over India

Keywords: Data Capture, Electronic Data Capture, Report Generator

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