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Pharmaceutical sponsors conducting clinical trials in the Asia Pacifc (APAC) region have a rare opportunity at hand: by adopting Interactive Response Technology (IRT), they can automate one o the last bastions o manual record-keeping in clinical trials and realize a signifcant uptick in productivity and data integrity. Sotware platorms that integrate the processes and inormation related to randomization and delivering drugs to clinical trial participants have been in use in major drug development countries or well over a decade. They have, however, not yet been widely adopted in APAC where study managers, investigators, and supply chain managers oten continue to manage randomization, track patients, and monitor inventory manually. In 2013, 16% o clinical trials were conducted in APAC, 1 and that percentage is destined to climb. It only makes sense or study teams in the region to avail themselves o the same automation and efciencies that their counterparts in other regions enjoy. Fortunately, users in APAC can “stand on the shoulders” o those in other regions and automatically reap the benefts o unctions and eatures that have been developed over the years and across thousands o trials. IRTs: ANIMAL, VEGETABLE, OR MINERAL? So, what exactly is an IRT system, and what can it do? IRT systems, which were frst introduced about 20 years ago, deliver a wide range o applications or managing patient interactions and drug supplies throughout the trial liecycle. In serving sponsors, drug depots, and sites, they automate: • PATIENT RANDOMIZATION , replacing physical envelopes or scratch- o cards. The system is pre-programmed to assign patients to treatment arms in a way that preserves blinding and allows or complex stratifcations and randomization designs, with enhanced balance among treatment arms • PRODUCT INVENTORY MANAGEMENT , allowing supply chain managers to have a real-time view o drug supply levels, locations, expiration dates, and storage conditions so as to orecast accurately and reduce wastage. Automatic re-supply shipments can be triggered, expired or damaged products can be removed rom the system, orecasts can be updated based on enrollment rates, shipments can be adjusted based on storage conditions and the product’s requirements, and drugs with or without individual kit numbers can be tracked IN 2013, 16% OF CLINICAL TRIALS WERE CONDUCTED IN APAC, AND THAT PERCENTAGE IS DESTINED TO CLIMB. 1 Clinicaltrials.gov
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