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Patient drug allocation options for clinical trials

Dacima’s web randomization module offers options  to configure different randomization methods, including simple, block, permuted block randomization as well as minimization to allocated the patient to the study arms. Once randomized the patient may also need to be assigned medication.  In blinded studies the treatment or medication  that is allocated to the patients will also need to be blinded.  Dacima’s randomization module allows you to easily configure the randomization process for different drug allocation options.

You can configure the randomization process to assign drug that correspond to the study arm the patient in which has been randomized. This design options allows the system to assign unique dispensing codes for each patient.  Dacima’s IWRS (web randomization module) integrates with Dacima’s Drug Management module, to allocate blinded dispensing codes (such as bottle numbers, kit numbers, etc) to the patient.  The Drug Management module also includes configuration options to to allow a single dispensing code per study arm or multiple dispensing codes. In trials that involve allocating more that one bottle per study arm, the Drug Management module allows you to define which drugs combinations need to be assigned per study arm.  The system will then automatically select the appropriate dispensing codes based on the arm to which the patient was randomized, as well as resupply the patient with the correct dispensing codes at future follow-up visits.

The Drug Management module also tracks site inventory levels and notifies the central pharmacy when inventory levels are low to help the coordinating site manage drug  inventory levels at the participating sites.

If the study design does not require you to manage unique dispensing codes (i.e. bottle numbers), the Randomization module also allows you to configure the randomization process to assign the randomized patients to different treatment group codes.  In this way, the system can be configured to display forma list of different treatment codes per study arm so that blinded user cannot determine which treatment code belongs to which study arm.

Dacima’s Randomization (IWRS) and Drug Management modules offer options to configure your trial drug or treatment allocation so as to maintain blinding, automate and simplify the process of drug allocation for randomized patients.

 

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