Clinical ink, a global life science technology company, is expanding its patient engagement solutions with the inclusion into its 21 CFR Part 11 platform of the SPUR behavioral assessment tool and the proprietary d.tells smart AI engine. These digital tools were developed by Observia, validated by extensive published literature, and used in over 40,000 patients across 27 therapeutic areas by multiple large pharmaceutical companies.
Protocol compliance and retention are critical factors for the success of clinical trials. Behavior can be predicted and modified by the SPUR digital assessment tool which identifies behavioral drivers unique to each patient. This provides supportive information to the patient, as well as measures of non-adherence risk to investigators. In addition, SPUR provides investigators with personalized guidance for each patient, including the communication style and content that will resonate with a specific behavioral phenotype. The benefits encompass optimized engagement and reduced risk of non-adherence, such as reduced drop out from a clinical trial. SPUR can be administered either prior to or after consent and then readministered during the trial.
SPUR can be further enhanced with the d.tells AI engine. d.tells chooses and distributes the most appropriate content and features from the solution library for each patient’s behavioral profile. It further refines the personalization by adapting the frequency, duration, and tone of the messages and notifications it sends, according to the patient’s sociomedical and behavioral data.
Nicholas Alp, MD PhD, Chief Medical Officer of Clinical ink commented “I am excited to see the value that SPUR™ will bring to improving adherence, retention, and data integrity in clinical trials. Not only does this validated tool help sponsors comply with FDA guidance on lifestyle standardization in certain therapeutic classes such as GLP-1, but it also offers unique insights to investigators, helping them support participant adherence to the protocol. This predicts and reduces the risk of drop out, preserving study power. I wish SPUR had been available during my career as a clinical trialist.”
“I’m thrilled that Clinical ink has decided to incorporate SPUR into their offering” says Kevin Dolgin, Head of R&D at Observia. “Clinical ink is one of the most forward-thinking clinical trial service providers and their commitment to bring behavioral science into the world of clinical science is proof of this. I strongly believe that thanks to Clinical ink’s initiative, trials will now be more efficient, more precise, and far more patient centric. At Observia, we look forward to continuing to support Clinical ink with behavioral science input while we assist our commercial customers post-launch. I can think of no organization that is better suited than Clinical ink to serve as the bridge between clinical and behavioral science.”
The terms of the transaction were not disclosed.
