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.
Alan Walter, cofounding partner of Walter Billet Avocats, comments : « Advising Clinical Ink for this asset deal required a complex understanding of the very specific scope of clinical trials, as well as its cross-border dimension. Anyway, such negociations between a global company and a Paris-based scale-up always need to find a particular balance with regard to the requirements of each party. We particularly thank Clinical Ink’s board for trusting us in providing them the best advice for this transaction which needed a strong IT accuracy. »