The Evolution of Randomization and Trial Supply Management Services

April 26, 2018 James Linnington

Recently PAREXEL® Informatics’ randomization and trial supply management (RTSM) solution, ClinPhone® RTSM, was named the leader of Interactive Response Technology (IRT), according to a global survey of pharmaceutical and biotechnology companies conducted by Industry Standard Research. Since 1993, this service has been used in more than 4,000 studies involving more than 2.5 million patients and 300,000 sites to drive efficiencies and reduce risk. Today PAREXEL reflects on the early development of RTSM services, its impact on drug development over the years, and where it’s headed in the future.

Two components fundamental to successfully executing a clinical trial are randomization and trial supply management. Randomization allows the sponsor to create balance in the group of patients treated, limits predictability of treatment allocation and eliminates selection bias, while supply management ensures the right medical supplies needed are delivered to the right patient at the right time, while minimizing waste.

Before RTSM technology, these tasks were conducted manually by clinical trial site staff. Sites relied upon manual processes to randomize medication, prepare and label medical kits, stock supplies and execute other essential tasks. These processes presented many challenges for sites and sponsors, including limited randomization methods, little flexibility, overstocking in supplies, and greater room for waste and error.

Over the past 20 years, sponsors have increasingly leveraged RTSM services to conduct their trials. As trials have grown in complexity, RTSM service providers have been able to adapt and utilize new technology to meet the unique and evolving demands of today’s clinical studies. The first RTSM systems delivered simple randomization with emergency unblinding capabilities, replacing existing paper-based manual solutions. The solutions continued to evolve as several vendors began offering RTSM solutions for sponsors with expansive technological features and software, including Interactive Voice Response (IVR) and Interactive Web Response (IWR), which created new efficiencies that lead to improved study start-up timelines. PAREXEL’s ClinPhone RTSM was one of the first solutions developed during this time, and was the first to introduce many new features as RTSM solutions evolved. In fact, ClinPhone RTSM provided the first web-based drug accountability solution to enable central management of investigational materials, allowing sponsors to effectively comply with requirements and demonstrate a full chain of custody for every medication. As sponsors began to adopt new software and technology systems, ClinPhone was also the first to synchronize data with an electronic data capture (EDC) system.

While the early solutions brought great improvements to trial execution, the RTSM services we know today are significantly advanced. Today’s solutions leverage the latest technology, including cloud-based software, easy integration with sponsors’ EDC systems and other eClinical applications, and customizable features to meet the specific needs of a particular study. These vendor-provided solutions have created efficiencies and supported accuracy, reduced trial timelines, drug waste and supply risk, and as a result have become increasingly critical to sponsors. According to Industry Standard Research (ISR) (i), 75 percent of life science companies surveyed say that they are using an outsourced solution. In addition, RTSM being part of integrated services for clinical trials is growing in importance for sponsors, with around 40 percent of those surveyed expecting somewhat or substantially more RTSM business to go to integrated service providers (as opposed to standalone IRT vendors) over the next 3 years (ii).

At present and as we look to the future of RTSM, there is great promise for these solutions as technology, such as mobile and the cloud, continue to advance. Vendors are now looking to see how technology can be evolved to support the largest group of users, the sites, in a way that reduces burden on their participation in a clinical trial while not impacting on study integrity or patient safety, and potentially enhances the experience Mobile technology is a key component in changing how trials are managed, and RTSM solution providers are increasingly adopting it, including PAREXEL. In February 2017, PAREXEL Informatics launched its mobile app for ClinPhone RTSM, delivering its RTSM services to sites via mobile, designed to enhance clinical trial supply management processes, increase patient safety and improve the chain of custody record for trial supplies. The app provides built-in barcode scanning capabilities, a first for the industry, allowing site staff to utilize the app to streamline common trial responsibilities, such as confirming correct treatment allocation and dispensation to patients, increasing efficiency while reducing time and room for human error. In October 2017, PAREXEL extended the mobile app with integration to Bluetooth-enabled temperature monitoring devices to track the temperature of individual patient medication packs from manufacturing through to a final check for patient safety before dispensation, also a first in the industry. New RTSM capabilities such as these are presenting opportunities for sponsors that once seemed impossible, such as direct-to-patient studies, where a patient anywhere in the world can participate in a clinical trial from the comfort of their own home.

PAREXEL’s Perceptive® Cloud is another example of how RTSM vendors are leveraging technology to improve trial management for sponsors. As sponsors increasingly utilize electronic platforms, keeping their trial data safe and secure has become a top priority. By leveraging the cloud, RTSM vendors have an opportunity to automate and streamline workflows and provide greater access to data, while keeping sponsors’ sensitive information secure and protected. It is essential that the RTSM service providers of today keep pace as new technologies emerge.

Over the past 20 years, RTSM services have advanced significantly, accelerating and simplifying the way clinical trials are conducted, all while reducing risk and timelines. With these services, sites and sponsors are better enabled to ensure that studies are randomized and blinded appropriately, eliminating bias, and that the right medication is being delivered to the right patient at the right time, with less waste and more efficient supply management.

 

(i) IRT Market Dynamics and Service Provider Benchmarking (2nd edition), Industry Standard Research, February 2018.

(ii) IRT Market Dynamics and Service Provider Benchmarking (2nd edition), Industry Standard Research, February 2018.

 
 
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