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How to identify the right CRO for your diagnostic clinical trial model

November 3, 2022

When it comes to clinical trial management services for diagnostic trials, the right contract research organization (CRO) can reduce sponsor burden and physician and site staff workloads while optimizing recruitment and overall study efficiency. 

An important differentiating factor between traditional clinical trial management companies and one that offers a more modern approach is that the latter can offer a holistic approach using internal software, site networks, services powered by technology, and more to run a trial from start to finish. A full-service diagnostics CRO is also able to capture and compile all necessary data pertaining to study execution, reported outcomes, and study results on one platform or dashboard.  

What is a diagnostics CRO? CROs services for diagnostic research studies:

Contract research organizations traditionally oversee all or most day-to-day operations of a clinical research study from start to finish. As studies become more decentralized by nature, the right diagnostics CRO can offer technology-driven services beyond traditional offerings to reach more patients, collect cleaner data, and tailor to the unique needs of individual diagnostic studies.

Diagnostics CRO services can look different for different types of studies. Each study is unique in its own way; diagnostics CROs can work with sponsors to design a study that properly scopes essential roles and responsibilities. Diagnostic research can take many shapes and form whether they are studies for home based diagnostics, in-vitro (IVD) diagnostics, liquid biopsy diagnostics, or oncology diagnostics. Depending on the study type the diagnostics CRO must have a wide range of capabilities to support.

Diagnostics CROs services for diagnostic research studies

Diagnostics CROs can manage diagnostic test administrations or shipping, dispatch mobile nursing or phlebotomists to collect and ship necessary samples, coordinate with previous care providers to obtain medical records, and more. An experienced diagnostics CRO team can manage complex site models, often needed for a more decentralized approach to diagnostic studies, without adding to sponsor, patient, and physician burden or workloads. This is made possible by a diagnostics CRO’s ability to design a trial that encapsulates all necessary trial components in a model that optimizes efficiency for all participating parties executed by sophisticated technology. 

Here are the three most commonly applicable study models to modern diagnostic trials that are enabled through a modern diagnostics CRO. 

Studies driven by community clinics

A diagnostic trial driven by community clinics is a Curebase model in which the diagnostics CRO enlists local care facilities, physician offices, test sites, or urgent cares to enroll patients into a study on-site when they come to that health care office. This model is ideal for diagnostic studies of acute infectious diseases focused on point of care where patients are likely to go to their local care facilities to receive a diagnosis and treatment. 

In this model, the diagnostics CRO oversees the use of a full eClinical suite, including eConsent (allowing patients to enroll onsite via a tablet or mobile device), as well as the administration of diagnostic tests and ePROs. In order for a diagnostics CRO to deliver on this model, it must have a wide-spread network of community clinics and care facilities ready to deploy – a service that most are not equipped to provide. Curebase, however, has utilized its network of local facilities to enroll over 2,000 patients using this model. Curebase’s technology and staff augment these clinics’ capabilities to enable them to collect clinical data for the study. This enables clinics to participate in research they normally wouldn’t due to the added administrative burden that traditionally comes with participating in clinical research. 

Virtual site studies powered by home health tools

This type of trial model is ideal for diagnostic tests that do not require in-person visits but do require sample collections from patients. This model could be particularly useful to reach endemic regions where a particular disease occurs, such as Lyme disease in areas with high deer populations. 

In this instance, diagnostics CROs can deploy mobile nursing and phlebotomy services to collect patient vitals and blood samples. Diagnostics CROs can use virtual platforms to enable follow-up telemedicine appointments as necessary and proper ePRO collection as well. 

Hybrid site studies

This study type is applicable to diagnostic studies that require an initial in-person visit with no need for additional in-person follow-ups or on-site sample collections. This type of diagnostic study may utilize a diagnostics CRO with test shipment capabilities, telemedicine options, and mobile nursing and phlebotomy capabilities as well. 

Although there may be a need for an initial in-person assessment, the diagnostics CRO can implement the necessary tools to remove all non-essential in-person visits allowing a more convenient trial experience for patients and making it easier for trials to overcome geographic burdens. 

Want to learn more about our Diagnostics CRO capabilities? Visit our Diagnostics Offering page.

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