How to decide which IRT/RTSM vendor to trust with your trial

There is so much to consider when deciding which IRT/RTSM vendor to trust with your trial.

It’s important to note that technology is only one part; you also need to rely on the people and the service they provide for the life of the trial.
Here are 3 areas you must consider:

1) Fundamentals: do they get the essentials right every single time?

An IRT can be seen as a technology, a commodity, a line item on a spreadsheet. The core of what an IRT offers, RTSM, is critical to the success of your clinical trial – the randomization of participants to the correct treatment group as per the protocol, the continued treatment of each participant as per the protocol and maintaining the blind throughout. You expect a vendor to just get the essential RTSM part right with ease.

You should also expect to be provided with the capabilities you need to manage the trial efficiently and effectively from start to end – from user access, site initiation and batch release to database lock and final data release, with seamless integration with anyone and anything.

2) Flexibility for your trial: can they support your specific trial needs?

In addition to being assured that the fundamentals are taken care of, you need to consider the specific needs of your trial: this includes the protocol design, the packaging plan, and any study management/operational needs. For example:
— If you have a vaccine trial with one medication type and 2 visits, your needs are not complex (relatively), and you want a vendor who can deliver the IRT system in just a few weeks!
— If you have a multi-part dose finding adaptive cohort oncology trial with flexible sourcing of Standard of Care treatments, your needs are more complex.

You need to look for a vendor with a flexible system which can be configured to deliver quickly and can also be tailored to meet the specific needs of all aspects of your trial You want the people designing the IRT for you to have a deep understanding of your protocol, the therapeutic area, and supplies management.

3) Future-proof: can they support the known unknowns?

It is unlikely that an IRT system can meet all possible clinical trial needs with just configuration; all have core capabilities for typical study, supply, and subject management…all can randomize participants to treatment and make sure the right trial supplies are on site on time, but you need to consider your novel needs, your new challenges – the future.

We have all experienced over the last few years how global events can change study operations, can challenge study design, can force new ways to manage new situations…supply chain disruptions and the inability for participants to make in-person visits a few.

We have seen the increase in novel treatments such as precision medicine, with specific challenges of patient-led supply, including personalized manufacture and shipping and challenging visit and expiry management.

We know from experience that trials never go exactly to plan, from a delay in the release of new batches of medication which puts participant treatment at risk, to recruitment delays which put study milestones at risk, to the need to immediately close a treatment arm to manage a safety risk…you need a vendor with the adaptable technology and expert teams who can help you manage the unexpected and keep your trials on track.

In summary, you need a vendor who can flex with the technology, who can adapt and be future proof. You need a vendor who offers flexibility plus gets the fundamentals right every single time. You need a vendor who can manage the simple to the complex and everything in between. You need people who understand and support your challenges, who are proactive, responsive and keep your trials on track. You need a technology-enabled service.

Here we share what’s essential for you to consider when selecting an IRT/RTSM vendor who can support the successful implementation of your trial, considering both the technology and the people…

We plan to also share an extended list, including additional questions for your IRT/RTSM vendor covering technology, people & process.