In 2014, 23% of clinical trials were conducted in the Asia Pacific (APAC) region, and that percentage is destined to climb. To keep up with this pace, APAC study managers, investigators, and supply chain managers (who have, until today, managed manual record-keeping in clinical trials) need to automate.
Interactive Response Technology (IRT) systems— used to manage patient interactions and drug supplies during clinical trials—perform a range of functions for sponsors, drug depots, and investigative sites.
Pharmaceutical and biotech companies are increasingly reliant on their CROs (contract research organizations) and vendor partners to provide innovative, cutting edge solutions that will help them bring new therapies to market faster. According to a recent market research report1, the global clinical development outsourcing market will reach more than $64 billion by 2020, with CROs managing close to 72% of all clinical trials. As sponsors continue to adopt the outsourced model, sponsor-vendor relationships will play a pivotal role in the success of the clinical trial.
A leading biotechnology firm with a reputation for delivering quality solutions was tasked with conducting a groundbreaking multicenter study evaluating the safety and efficacy of a new oncology drug in patients with pancreatic cancer.
Once a clinical study starts, the outcome will not exactly match the forecast. However, it is important to optimize clinical trial supplies to ensure that the outcome is as accurate as possible.
When setting up the IRT (IVRS/IWRS) systems for any study, it is prudent to bear in mind the costs and time impacts of potential changes in the future. There are IRT or IVRS systems that come with modular set-up to enable them to respond faster and more efficiently to changes needed while the system is still alive.
IRT (IVRS/IWRS) systems help in handling the logistical issues related to the conduct of clinical trials. Modern systems are web-based and can be accessed anytime of the day or night through the internet or telephone connection. This allows for seamless management of drug supply, lab samples, patient enrollment and randomization, patient diaries, drug returns and reconciliation, and temperature excursion.
Clinical trials are usually expensive and can take many months or years. There are also high chances of things going wrong at just about any stage. A good IRT (IVRS/IWRS) system is supposed to minimize the risks, reduce the timelines, and cut the costs of development. It should also be flexible enough to allow for simple management of complex and adaptive studies that are being undertaken.
Some clinical studies can be very large and usually cover different areas. There is a need for seamless coordination and integration of data from all areas of study into a central lab for analysis. A good IRT (IVRS/IWRS) will also be helpful for event and visit tracking during these large clinical studies.