Randomization & Trial Supply Management Comes of Age: What’s Next?

Nov 3, 2019 | Interactive Response Technology, IRT, IVRS, IWRS, RTSM, RTSW

Randomization & Trial Supply Management Comes of Age: What’s Next?

Interactive response technology (IRT), also known as randomization and trial supply management  (RTSM) is used by clinical trial sponsors to help generate subject number assignment, investigational product (IP) and medication distribution, resupply and trackingnot to mention offer real-time status reports and metrics into the health of a particular clinical trial.  

Over the years, this class of  clinical trial technology product has gone by different names depending on its state of evolution, starting as a manual, paper-based process to inclusion of telephone (Interactive voice response or IVR) to web technologies (inteactive web response or IWR) to mobile platform (interactive mobile response or IMR) to a catch all term (Interactive Response Technology or IRT) and hence it has been at times called, interchangeably by the acronyms IVRS, IWRS, IXRS, IMRS and IRT and most recently randomization and trial supply management or RTSM.

History

Up to the 1990s

Before the 1990s much of the business of randomizing patients and supplies for a clinical trial was accomplished manually. For example, sponsors would ship patient-numbered kit labels to all sites in blocks corresponding to the course of treatment for the study. This resulted in large amounts of wasted supply. 

By the 1990s the interactive voice response system (IVRS) class of solution emerged supporting the ability of clinical investigational sites to use a telephone to call into a system in order to randomize patients and later on—dispense dug and resupply sites. Moving forward, sponsors could distribute interchangeable patient kits. 

2000 to 2012

As the internet emerged, the first rules-driven, web-based (Interactive Web Response Systems or IWRS) were introduced to the market. By the early 2000s, both IVRS and IWRS were used to describe these systems depending on modality (e.g. phone or web-interface).  The term IxRS was used to imply either modality which also could confuse buyers even more.

2012 and Beyond

Today we consider the umbrella term IRT for Interactive Response Technologies. Now a competitive, dynamic and rapidly commoditizing randomization and trial supply management (RTSM) market unfolds, with advancing features and functions making systems incrementally more advanced for the entire clinical trials lifecycle from study start up and conduct through close-out as reported in an overview a few years ago by the life sciences consulting arm of Tata Consulting. With the advent of cloud computing, big data as well as the ubiquitous nature of mobile platforms not to mention AI (machine learning and natural language processing) heretofore not possible breakthroughs such as more automated configuration and fully integrated site-facing clinical data and documentation systems will be increasingly available in compelling, relatively economical software-as-a-service (SaaS) options. 

Today the market demands the following from any IRT/RSTM vendor including:

  • Deep subject matter expertise infused into delivery team and product/cloud services offering itself
  • Intuitive interfaces for rapid ramp up and adoption
  • Proven and ensuring Quality with track record of Compliance
  • Superior clinical supply forecasting potentially powered by intelligent algorithms 
  • Seamless maintenance upgrades with little validation headaches
  • Demonstrable support with competitive service level agreements (SLAs)

Turnkey for Emerging Biopharma & SME CROs

As the drug development world moves from the big blockbuster model to precision, value-added products—or from volume to value—new RTSM advancements truly benefit small to mid-sized biopharma sponsors, not to mention hundreds of niche CROs serving them. While tier 1 big pharma and their CROs use often heavily customized, proprietary systems interfaced with other customized “eClinical” platforms, the market will capitalize on ongoing RTSM transformation, not to mention ongoing underlying technology advancements, to drive economy and savings while boosting productivity and effectivity.

Market Evolution

IRT was typically used in Phase II and Phase III clinical trials (wherever the sponsor needed randomization, treatment assignment or supply management) however as Phase I trials become more complex (e.g. intricate protocols, complex dosage and diversified populations to name just a few examples) advanced IRT and “RTSM” emerge characterized as rapidly provisioned, cloud-deployed, intricate configurability, economical and robust to manage all data elements of emerging complex Phase I clinical trial. Increasingly some of these systems are built to seamlessly integrate with other “eClinical” systems from electronic data capture (EDC) to patient reported outcomes (ePRO) to other “decentralized data capture capability made feasible not only by the mobile platform boom and the demand for not only easier site access and usability but patient-centricity in clinical research. 

Benefits of Today’s IRT to RSTMs

Advanced IRT system vendors now battle in the market to  showcase the next level of benefit and capability from convenience for sites and their staff to opportunities for extending systems to patient engagement to seamless interfacing with other systems and  hence the advancement of robust RTSM options. Increasingly, sponsors and CROs covet systems to not only randomize and track patients across world sites but also manage and track study drug/investigational product across what can be large, complex global studies often where different countries may have different laws and regulations concerning the management (including import) of investigational product. Sponsors demand ever greater benefit such as pooled investigational product for superior tracking across sites, depots throughout the lifecycle of the study and product. 

Vendor Landscape

Today’s IRT market offers a range of vendor representing large multinational to niche start up. As the technology, processes and requirements mature and harden, sponsors and CROs have the ability to carefully, methodically and strategically make the right selection, benefiting from not only product but an infusion of deep knowledge and important lessons-learned.  

When acquiring or licensing an IRT from a SaaS vendor, Tom Schiavon does a fine job for Clinical Leader–a nice publication that does an especially good job tracking clinical trial vendors and best practices–breaking down and delineating key selection considerations.

Mr. Schiavon, addresses key criteria in the Clinical Leader piece including 1) Compliance; 2) Development and Testing; 3) Design Considerations and Strategies and 4) IRT Operational Best Practices.  Well worth the read—although cursory they hit key pertinent points.

What follows is a brief overview of the RTSM/IRT market with a sample vendor breakdown.

Vendors & Their Targets

IRT or “RTSM” vendors can be segmented by 1) Contract Research Organizations (CROs) that include RTSM/IRT technology-enabled services; 2) “enterprise eClinical suites” that include technology-enabled IRT services targeting biopharmaceutical companies and CROs; 3) clinical services providers offering point solutions to biopharmaceutical companies focusing on clinical trials; 4) newer, VC-backed startups with IRT/RTSW emphasis or niche start up and pure-play “other options” included below.  

Each one of these vendor categories may target and service various target markets including:

Biopharma Clinical Sponsors 

  • Tier 1: $10+b 
  • Tier 2:   $1b-$10b
  • Tier 3:   $100m to $1b
  • Tier 4:   $100m & under & pre-revenue

Clinical Research Organizations (CROs)

  • Tier 1:  $2.5b+
  • Tier 2:  $1-$2.5b
  • Tier 3:  $1b to $100m
  • Tier 4:  $100m & under

Major Academic Research Centers

Government Clinical Research Sponsors

Non-profit Clinical Trials Networks

Contract Research Organizations (CROs)

The largest CROs offer some form of IRT service (often they may have more than one offering depending on division), whether they have built-in-house, purchased or if they in-license (OEM or resell) via a partnership model. CROs offer end-to-end clinical trials services including technologies and IRT/RTSW represents one of many such offerings. As mentioned, the largest global CROs typically involve multiple mergers and may offer multiple systems such as IQVIA (Quintiles with Clintec et al) as well as an interest in IRT pure-play Cenduit; Laboratory Corporation of America (Covance et. al.) includes Xcellerate integrated suite—as well as other systems picked up via acquisition; Parexel (Clinphone); and Syneos has used Almac (via acquisition) as well as others. Smaller CROs such as Medpace and Bioclinica also offer IRT-technology-enabled services. 

Integrated eClinical  Vendors

The large “eClinical” enterprise suite vendors, such as Oracle and Dassault Systems (Medidata), not to mention mid-market players offer IRT purportedly integrated with EDC (electronic data capture); clinical data management and other systems. For example, Oracle offers a tool that came along with the Phase Forward acquisition a decade ago while Dassault offers its recently acquired Medidata’s product. Although Veeva Systems has come on strong with CRM, eTMF,electronic data capture and trial management software they have expressed an IRT partnership model—a smart move on their part. Mid-market players such as Omnicomm Systems, a Florida-based eClinical firm, also include a bundle of purportedly integrated services from EDC and trial management to trial master file and IRT/RTSW.

Clinical Services Providers

Firms such as Cenduit were set up in the first place to provide robust global IRT/RTSM services. Almac likewise has a long history of providing a range of global services to sponsors and sites as does Signant Health (Bracket) that recently supported an important AD trial in China. Mid-market ventures such as Sharp Clinical Services offer packaging and clinical supplies not to mention IRT services via the Alea Clinical platform, which was originally formed by the Netherlands Cancer Institute. 

VC-Backed New Upstarts Dedicated to Advancing RSTM & Related Technologies

Over the last several years, new eClinical startups have formed, often backed with considerable venture capital, seeking to offer better, faster, cloud-enabled technologies including RSTM/IRT. We include examples such as Suvoda; Yprime; 4G Clinical; Endpoint; Clinical Studio by Clinical Data Solutions; and Netherlands-based electronic data capture and IRT vendor Castor EDC.

Other Systems

A range of other systems have been designed and implemented over time from custom, in-house solutions in big sponsors to government agencies and academic research centers to what started as government-funded systems such as Alea Clinical. For Example, Alea Clinical represents an interesting option—originally funded by the Netherlands Cancer Institute and the European Commission to offer an integrated electronic data collection, source data capture and interactive response technology/RSTM for European academic research centers with a focus on oncology. Alea Clinical has since become privatized, powers over 50 academic centers and now enters the North American market.

Conclusion

The Interactive Response Technology (IRT) market space, called by some as Randomized Trial and Supply Management (RTSM) becomes an ever more part of a modern, advanced clinical trial infrastructure for biopharma companies and CROs. Clinical trials sponsors must utilize innovative technologies to compete in globally competitive drug markets. Successful implementations of IRT/RTSW can not only accelerate clinical trial by remote management and improve data quality and trial execution but also infuse greater productivity and effectivity into clinical trials that must become more site friendly and patient-centric.

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