Question 1

What’s the scope of the Trial Eye services within the whole clinical trial process?

Accepted Answer

The Trial Eye services specifically focus on local study startup and patient recruitment as these are the most rate limiting steps in the whole drug development process. Only 5% of patients participate in clinical trials while 50-80% of patients indicate they would like to. Even so, local study startup processes of clinical trials in study sites can sometimes take up to 9 months because of lengthy manual and resource intensive processes. By creating a network of study sites that can be fully operational for each clinical trial within several weeks we create earlier and extended access to clinical trials. Focusing on these 2 bottlenecks means that drug development time can be dramatically decreased.

Question 2

What’s in it for a study sponsor?

Accepted Answer

Study sponsors want to bring their new medicines or treatments to patients as soon as possible by building robust data from clinical trials. To be able to build data, patients must be included rather early then late. This requires fast study startup within study sites and as many sites as possible open for patient recruitment. Opening a large amount of study sites is often not possible because of logistical, organizational or budgetary reasons. Initiating clinical trials through the Trial Eye platform solves these issues for study sponsors because the Trial Eye platform provides access to a whole network of study sites that can be initiated for recruiting patients within serval weeks with only one point of contact!

Question 3

What’s in it for a study site?

Accepted Answer

For study sites it’s important to be able to participate in many trials to serve patients’ needs and advance science. Because of strong clinical trial legislation and regulations, and because of the fact that study sponsors offer their clinical trials in many forms and shapes it’s hard for study sites to actually participate in many trials. A lot of resources are used for administrative support instead of using them to coach patients through a clinical trial. Trial Eye network sites are provided with standardized and harmonized online workflows that take away a lot of administrative burden of clinical trial staff. All trials are offered in the same transparent way speeding up local study startup. Study sites can participate in more clinical trials using less resources and helping more patients.

Question 4

Who can access the Trial Eye platform?

Accepted Answer

As clinical trials contain a lot of sensitive information about medicines or treatments in development, access to Trial Eye is restricted and password protected. Before entering the Trial Eye platform users have to accept the Trial Eye user terms. These terms state which information is accessible for whom and which user data will be used for what. In short: study sponsor staff and study site staff can only access those parts of the clinical trial documents that are necessary to perform their part within a trial and personal data (like CV’s and ICH-GCP training certificates) are only used for clinical trial execution purposes.

Question 5

How do the Trial Eye Services compare to CRO services?

Accepted Answer

iClusion has analyzed the whole clinical trial process and defined the 2 most important rate limiting steps. To solve these, and only these 2 clinical trial challenges, iClusion has designed an online infrastructure that is specialized in overcoming these challenges, while connecting all other steps and service providers. Trial Eye services thus only include study startup and patient recruitment services.

CRO’s often offer many more clinical trial services (like protocol writing and national approvals) but their main and most important task remains data capture, monitoring and analysis. Once a trial is locally approved initiation will take place by the sponsor or CRO.

Once a patient is matched and informed, the patient is randomized and included by the sponsor or CRO within their systems and data capture, monitoring and analyzing is thus not done within the Trial Eye infrastructure.

Question 6

What about patient data?

Accepted Answer

Patients will be matched to clinical trials and informed (ICF) by treating physicians through the Trial Eye infrastructure without entering or leaving patient data in the Trial Eye system.

Its patients’ profiles that will be linked to possible suitable trials. By studying the actual protocol the physician can then decide if the patient actually can be included and start the ICF procedure. The signed document will only be stored physically within the study site and/or digitally within the sponsor’s or CRO’s system. The Trial Eye infrastructure only provides a standardized procedure to access, start and monitor ICF procedures.

Each event of matching a patient will generate a unique Trial Eye event number that can be tracked on informing and routing towards the sponsor or CRO systems for randomization and/or inclusion.

Clinical trials should always be an option

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Frequently Asked Questions

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