Running a decentralized clinical trial is a challenging task.
Patient visits need to be arranged and coordinated with a bank of community healthcare practitioners. Reliable, accurate, and suitable equipment needs to be supplied and distributed to teams working far away from any central hub. And both regulatory and data security concerns must be addressed in full, especially with the rising capability and popularity of a new generation of connected devices which feature a range of point-of-care-testing (POCT) and continuous glucose monitoring (CGM) products.
Here are seven challenging questions to help you determine if your potential equipment supplier is the right partner for your decentralized clinical trial:
1. Do they partner with secure data handlers to transfer confidential patient data from new devices?
Guaranteeing data security in decentralized clinical trials is critical. You may want to use the very newest and most capable connected devices. And, yes, your potential equipment supplier may be able to supply this hardware. But that is only the first stage.
An important consideration is whether they have the data partnerships in place to ensure you can securely and remotely retrieve patient data in a way that is regulatory compliant and does not compromise patient confidentiality. A negative answer here could potentially delay your trial’s start date and significantly add to your administrative burden.
2. Do they have sufficient equipment knowledge to provide a customized advisory service?
Every decentralized trial is different. But the same broad challenges exist for sponsors or CROs, because the equipment in which you are forced to put your trust to gather the data you need is not in your proximity. When your healthcare professionals start their patient visits, the equipment they carry must be capable of following your protocol to the letter.
So it's crucial that your equipment supplier is able to interrogate your protocol, determine your needs, and provide tailored advice to help you secure the most appropriate equipment for your trial.
3. Do they understand the regulatory environment in which you operate?
Delivering equipment to your team is one thing. Understanding the specific regulatory environment of your country and region, and the impact that may have on the potential equipment you can use, is a significantly more complicated task. When you’re building the supply chain for your decentralized clinical trial, take time to ensure that your partners have the necessary international knowledge to avoid potentially costly and time-consuming mistakes.
4. Are they able to supply multiple sites simultaneously?
With a decentralized trial, equipment is not necessarily being delivered to a central hub. Instead, it may need to be directed to multiple individual mobile or travelling healthcare practitioners ahead of the patient’s home visit, for instance. Check that your equipment supplier is able to navigate this extra layer of complication, without jeopardizing your ability to meet your study’s deadlines, before finalizing any agreement.
5. Do they have broad experience across all clinical trial setups?
Make sure your supplier has a proven track record across centralized, decentralized, and hybrid clinical trials. This breadth of experience points towards a company that has the team, expertise, structures, and distribution networks in place to provide consistently high service levels. If your supplier cannot point to its previous experience, you may want to reconsider your assessment of their suitability.
6. Do they provide peace of mind by offering expertise, dedication, and reliability in a complete one-stop-shop service?
From customized and expert advice through to sourcing, distribution, delivery, technical support and training, and data security partnerships, does your chosen supplier reduce any potential complications at every possible turn? A world-class supplier will pride themselves on being a trusted partner to sponsors and CROs running complex and challenging decentralized clinical trials. They will offer advice and insight that makes the life of the study’s sponsor or CRO both easier and more efficient.
7. Do they understand the empathy, humility, and sustainability delivered by decentralized clinical trials?
Making home visits to patients and then remotely retrieving data throughout the rest of the trial offers several significant benefits, including a dignified and more humanized approach. They enable individuals who may not otherwise enrol in a clinical trial, perhaps due to mobility or transport issues, to participate with ease. The use of continuous monitoring products and speedy data retrieval can also accelerate the overall research process.
A world-class equipment supplier for decentralized clinical trials
With almost 35 years’ industry experience, Woodley Trial Solutions can categorically answer ‘yes’ to all of these questions. Our full range of lab equipment is trusted by sponsors and CROs around the world to facilitate ongoing clinical trials. Fast and compliant worldwide delivery comes as standard, with all materials stored in dedicated healthcare logistics facilities and fully calibrated before distribution. And we comprehensively understand the issues at play – for sponsors, CROs, and patients – during the roll-out and completion of decentralized clinical trials.
Wherever you’re based, if you’re looking for a decentralized clinical trial supplier you can trust, contact us today to talk through your requirements. We’ll be happy to help.
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