The IVRS provides the real time data tracking for:
Patient Randomization
Drug Information
Clinical Trial Material Tracking
Integration with Other study Management solutions and applications.
The Key benefits that IVRS provides are:
Automated access of information
Automated services
Remote access
PIN security
24/7 availability
Fast data Tracking
Cost effectiveness
Time savvy
Patient Randomization:
Patient Randomization basically includes three major fields - Subject (patient) Recruitment, Informed Consent and Subject History. IVRS (Interactive Voice Response System) assists a faster and flexible way in the registration of a subject. Moreover IVR system can avail remote site randomization of new Subject at any time.
In subject recruitment, Through IVRS, subject can telephone a toll-free number and answer a series of questions to determine their potential eligibility to participate. If IVRS finds the subject is eligible then it record subject details and store the information into database and those failing will be given information about how to seek further advice for their condition. Then IVRS generates an automatic alert to inform the study site or trained telephone caller to contact the subject. IVRS provides a centralized application and database that is beneficial for making changes in subject information during the study.
Making enrollment both more predictable and more efficient is a major quality benefit, as recruitment is the one of the activity involved in the study least in the control of sponsor.
Drug Information:
IVRS (Interactive Voice Response System) provides all necessary information at any time regarding investigational/comparator drug. It includes the information like -
Composition
Indication
Adverse events
Side effects
Warning
Providing information of drugs at right time during the research is a major feature supported by IVRS. Aforesaid information facilitates site managers to make decisions in drug allotment to a subject. Thus, plays a vital part in enhancing clinical trials in progress and makes it much more efficient and accurate.
Clinical Trial Material (CTM) Tracking:
Clinical trials basically deal with the management of inventory. IVRS provides a way to control the management of CTM inventory and is a valuable tool for dispensing medication and maintaining stock at site.
In an IVRS, medication procedure is based on pack numbers. All medication pack has a unique identification number. Any pack can be assigned to any subject in a same treatment group. At the place of tracking whole medication supply of a particular subject, applications use medication packets of a treatment for complete dispensing interval so that a complete dispensing unit can be allocate to other subject in the same treatment group. This approach will reduce the wastage of medication that usually occurs when a subject withdraws from the study.
Dispensing Medication and maintaining stock at site with the help of IVR system can be elucidated with the help of cycle that follows between the three .The cycles swivels between the three major factors i.e. IVRS inventory, database, Drug warehouse and the study site.
When a new subject arrives at a study site, the site manager makes a call to IVRS indicating the required dispenses and identifies the subject who requires the medication. The system then reports back the medication pack number that should be dispensed to the subject with reference to the known inventory of stock held at those sites. After the medicine has been dispensed, the involvement of site staff is finished. The IVRS dispenses the current medication pack, identifies that the stock at the site for that treatment has fallen to a predefined minimum level and sends an electronic request to the drug warehouse for a consignment of additional supplies to be sent to the site. And, this is how the coordination is maintained.
