Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, has officially announced the launch of a comprehensive contract research organization solution (CRO). According to certain reports, the stated solution will offer tailor-made proponents for sponsors looking to bring diagnostic products to market. Named as All-in-One Diagnostics CRO, this brainchild of Lindus will leverage the company’s expertise in testing, monitoring, and biomarker identification of indications across nearly all therapeutic areas to enhance diagnostics clinical trials. Furthermore, will also address the challenges associated with recruiting and managing data for very large patient studies. As for how it will do so, the answer involves combining expert CRO services and extensive experience in diagnostic clinical trials with the company’s repository of over 30 million electronic health records (EHRs) and a home-grown internal eClinical platform, Citrusâ„¢. Once integrated, such a combination should provide diagnostics sponsors with everything they would need to conduct research, all in one place. Talk about the whole value proposition on a slightly deeper level, though, it begins from an assortment of CRO and trial management solutions where the highlights is Lindus Health’s clinical operations team and its extensive knowhow in every facet of diagnostics clinical trials, ranging from protocol development and patient recruitment to data delivery. Next up, we must get into the offering’s bespoke trial management technology, which is concerned with the company’s proprietary eClinical software, Citrus. You see, on its part, Citrus comes bearing for us an ability to pack together all the technologies needed for trial execution, including the Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eConsent, patient scheduling, eConsent, and much more.
“Diagnostics studies have unique challenges that are poorly served by traditional CROs, who approach these studies much like a drug trial, and therefore fall short in delivering studies on time and on budget,” said Michael Young, Co-Founder at Lindus Health. “These studies require specific expertise in validating products against a standard of care and also have very demanding and unique recruitment challenges with some studies requiring thousands of patients. Most CROs don’t know how to handle studies at this scale except through, driving immense cost and trial complexity.”
Then, there is the prospect of availing large-scale recruitment capabilities, capabilities that translate to how users can bank upon several different recruitment tactics to accelerate patient enrollment. The stated goal is, markedly enough, helped by Lindus Health’s primary care network of over 30 million EHRs and an in-house digital marketing team for social media advertising campaigns. Hold on, we still have a couple of bits left to unpack, considering we still haven’t discussed the new CRO offering’s comprehensive foundations when it comes to knowledge of regulatory pathways. To better understand the given detail, we only have to look at Lindus’ extraordinary track record in initiating numerous trials for FDA 510(k) and De Novo submissions, something which also hints at the company’s tendency to keep pace with the new industry developments. Finally, we can expect to be in play a top-notch brand of site services and network. By top-notch, we refer to how Lindus Health’s dedicated site operations team fosters strong relationships with principal investigators (PI) and research staff, and therefore, effectively carries out trials of various models. Some of these models include single, multi-site, as well as remote/hybrid, and traditional settings. Alongside versatility in the context of trial’s nature, the company also enables enough flexibility for sites to be deployed across its primary care and specialty care network, depending on the needs of the study population.