A new approach requires new terminology.

Click SE™ solutions offer a new approach to medicine, which combines software with pharmacotherapy to create software-enhanced drug™ treatments. We work with pharma to create “SE” (software-enhanced) formulations of their pipeline and marketed drugs that offer added clinical benefit. Click SE™ solutions build on Click’s proprietary AI-enabled platform and our deep experience developing regulated prescription digital therapeutic treatments with global pharmaceutical innovators.

A decentralized clinical trial (DCT) is a study that utilizes digital technologies and remote methodologies to conduct some or all trial activities outside of traditional clinical sites. 

Software-based interventions with the intention to prevent, manage, or treat a medical disorder or condition. These are under FDA enforcement discretion, but do not need to be prescribed by a licensed healthcare professional (HCP).

These proprietary interventions aim to target or correct specific neural pathways in the brain that are faulty through structured audiovisual, haptic, and cognitive stimuli.

We design and develop treatments that prioritize patient needs, preferences, and lived experiences.

In September 2023, the FDA released a new draft guidance document titled Regulatory Considerations for Prescription Drug Use-Related Software (PDURS). This guidance describes how the FDA intends to apply its existing drug labeling authorities to software outputs associated with prescription drugs or drug-device combination products, covering a full spectrum of use cases. It provides clarity on when certain types of software can only be described in promotional labeling or when it is appropriate to include in the FDA-required labeling such as the package insert.

PDTs deliver evidence-based treatments directly to a patient via their smartphone in the form of a mobile app. With PDTs, the software is the treatment. PDTs are prescribed by a physician to treat a disease or condition, and as such are clinically validated and FDA-regulated, much like a medicine. PDTs can be used independently or in combination with traditional pharmaceutical treatments.

Software-Enhanced Drugs™ treatments are drug-software combination products designed to enhance the value of a specific drug, built on the rigor and principles of prescription digital therapeutics (PDTs). Software-enhanced drugs (SEDs) target the unique needs of a medication and patient population to deliver added clinical benefit. Compared to other PDURS solutions, these treatments are differentiated by a high level of clinical rigor and offer patients an engaging and personalized treatment experience to achieve superior clinical outcomes, which are measured in clinical studies with gold standard endpoints and listed in the drug label.

Digitized version of widely accepted evidence-based treatment mechanisms, optimized for smartphone use.