Is it possible to increase the flexibility of clinical trial operations while still lowering costs?
The operation of clinical trials covers a broad scope of activities, from protocol compliance and participants’ safety, to data quality and sharing of data. At the same time, the emergence of rare conditions and new kinds of medicines push the boundaries for the coordination and logistics of direct-to-patient studies.
In this context, when pharmaceutical companies follow traditional processes and collaboration models without opportunities to modernize and adapt – for example to at-home clinical trial conditions – then more time is spent on administration and coordination, with higher associated operational costs.
Why are traditional clinical trial processes not scalable?
Running an at-home clinical trial requires a delivery model that is as flexible, responsive and personalized as, say, an Amazon delivery, but that is also sophisticated and precise enough to adjust to different stakeholders’ requirements. Traditionally, studies have been contracted with a number of specialized Contract Research Organizations (CROs), based on a clear and fixed study protocol and number of study sites. Coordination and logistics have been organized between the study sponsor, the CROs, suppliers and the sites. Patients visited sites to be treated, with very few ‘gadgets’ to use independently outside the doctor’s office.
Some pharmaceutical companies have two internal organizations for study logistics: one for non-regulated materials (‘ancillary’ supplies) and one for regulated ones (such as the Investigational Medicinal Product (IMP)). Instead of dealing with CROs and the study sites, both organizations are required to serve patients in their homes while distributing and managing growing numbers of increasingly complex devices and appliances, from smartphones and wearables to CDs and memory sticks. The impact of this in terms of coordination and logistic is substantial, especially when studies need to be increasingly flexible.
“When pharmaceutical companies follow traditional processes and collaboration models without opportunities to modernize and adapt, for example to the needs of at-home clinical trials, then more time has to be spent on administration and coordination, and operational costs are higher.”
A holistic approach to optimize clinical trial operations
Making changes and improvements is very difficult within the constraints of a traditional delivery model involving several providers. So, how can we simplify trial operations, increase their flexibility, and still optimize costs?
This was the question we were engaged to address by one of the world’s top three pharmaceutical market leaders. The company was looking for a way to avoid increasing logistical complexity in its clinical trial operations. In response, we analyzed the company’s approach and requirements, devised a solution and piloted it with one of the company’s clinical studies operating across 25 countries.
Building on this concept, we tested and fine-tuned the process and built a single digital platform for holding and visualizing all the related data. Using this solution, and working with local partners, we can orchestrate an efficient clinical trial operation that is truly end-to-end:
1. Sourcing: all operations related to sourcing and setting up all the contents of the study kits (digital, medical, IMP). We work with the study sponsor to build the kit with all the necessary components (including special instruments, wearables, mobile phones, apps, scanner, training material, and encompassing all related sourcing, packaging, stock and asset management) and ensure the kit reaches each end user. At the end of the trial, the kit is recovered, disposed or reused (including, for example, secure data deletion, refurbishment).
2. Distribution: worldwide distribution to the patient’s home, irrespective of how far the participant lives from a major city. We specialize in compliant home delivery and collection in over 53 countries, including all required export / import formalities for countries with heavy compliance requirements like Russia, Brazil. Our end-to-end Track&Trace ensures that study kits are localized with a compliant status report (see the picture below for a sample process).
An example of a controlled end-to-end shipment process, with constant temperature monitoring and real-time Track&Trace
3. End-to-end management: to give stakeholders one integrated, consistent and compliant platform to follow the process step-by-step, with one single source of truth (as shown in the example below). This frees up the sponsor’s teams to focus on managing each clinical trial without having to jump into operational details, but with the assurance that everything is under control. Built-in process automation ensures timely and secure issue resolution.
The platform is a single source of truth for each study, all stored and easily searched and visualized as needed by study stakeholders
A simpler, more flexible and efficient clinical trial
Since then, the solution has been deployed for over 30 clinical trials, with high satisfaction levels among sponsors who have reaped significant benefits.
Perhaps the most popular feature for sponsors is that the clinical trial kit deployment is managed and delivered by just one partner (instead of having to liaise with many, with different service levels and statements of work). This results in 45% to 60% less administrative time spent by the sponsor’s team, with 15% to 25% lower handling and distribution costs.
What’s more, one single integrated platform with all the relevant data enables exact and reliable tracking of study kits and IMPs, and a better prediction of study performance.
Also ranked very highly is the flexibility to adapt for the changing needs and conditions of a clinical trial, such as additional participants, sites or countries, without the need to look for other partners or amend rigid statement of works.
We hope to be working with more pharmaceutical and biotech companies to turn these significant benefits into reality for more clinical trials.
If you are interested in gaining efficiencies in your clinical research and developmental processes, please get in touch with us for more information.