Clinitec Patient Randomisation

The randomisation of patients to a treatment group is a critical component of every Clinical Trial. Clinitec's Interactive Voice Response System (IVRS) and Interactive Web Response System (IWRS) provide convenient, real-time, secure, confidential access to a centralised study database to help manage this process - with a focus on Phase II and III trials.

The IVRS, combined with the ubiquitous phone and fax services, makes study deployment fast and easy. The IWRS allows study administrators and investigators to securely interact with the study database using a standard web browser and email services. Both services can be accessed from any location worldwide and, for flexibility, you can choose to implement both of these technologies concurrently if desired.

The IVRS and IWRS services, and the initial study preparations and documentation, fit into the familiar manual processes of organisations running clinical trials.

Randomisation Protocol

In developing randomisation protocol for a trial, the first step is to identify a small number of patient characteristics that need to be balanced between treatment groups, referred to as "stratification variables." A number of algorithms have been developed to reduce the chance of imbalance between treatment groups. These work by making it more likely that a patient with a particular characteristic is allocated to the group in which this characteristic is under-represented at the time of randomisation.

The Trial Sponsor is responsible for defining the randomisation methodology or the creation of the Randomisation tables and these are provided to Clinitec at the start of the trial. They are then loaded into the Clinitec system database for access via either IVRS or Web.

Optional Functions

Trial Management

Clinitec initially works with its clients to develop a Systems Requirements Specification for each study. Then we use pre-developed templates to speed the development of all associated documents (Worksheets, Faxes, Reports, Access Envelopes and User Manuals).

A complete IVRS test environment is then established for final validation.

Prior to "go live" the client supplies the actual randomisation schedule and site details (centre number, hospital name, fax number, valid CRF range for the site). Clinitec tests the fax capabilities of each site.

Each Investigator and Administrator is given a secure envelope with initial access details and a user manual. On site, the Monitors and Investigators complete the Account Setup Worksheet and call the IVRS (or login to IWRS) to setup their individual accounts, and they may choose their own PIN.

Subsequently, to randomise a patient to a study, Investigators call the IVRS (or login to IWRS) and follow the prompts to input patient data. A confirmation fax or email is then sent to the site.

Report Recipients monitor the trial progress through comprehensive & customisable periodic reports. Occasional reports are also available (eg: after 1st, 5th, 20th Randomisation) for independent statistical analysis.

Service Features