New PK and PD Analysis Options

USE CASE

Unlock a new level of confidence in your data.

Get on-demand adherence data and derived insights across the entire participant population. Conduct unprecedented data filtering, analysis, and reporting based on accurate adherence data. Gain assurance that studies are on track to meet their endpoints.

Solutions

De-Noise the Analysis

Non-adherence is a primary source of noise, making it mor difficult to discern a therapeutic effect. Measuring adherence lets you apply techniques for sanitizing the data, making therapeutic signals clearer if one exists.

Model Plasma Levels

Our adherence data has been shown to correlate extremely strongly with drug plasma concentrations. This lets your teams create more complete physiological models of each participant or conduct fewer blood draws: using adherence to infer plasma levels more completely, and therefore requiring fewer site visits.

Stratify by Adherence

Our software includes powerful tools for sorting and filtering participants based on numerous adherence dimensions. This enables you to create segments and cohorts based on the criteria for your adaptive protocols.

Specific Benefits

Fewer Participants, Same Power

Basing final PK and PD analysis on a more selective group of highly adherent participant can yield the same power despite having a smaller number. This selective group can be achieved either by adapting enrollment or by stratifying data post hoc.

Adjust Outcome Measures

Apply statistical techniques such as covariance analysis to see if there is an adherence effect and use our adherence data as a parameter, in order to better understand efficacy, side effects, and more.

Better Phase III Go-or-No Decisions

Once safety and tolerability have been assessed, adherence data can support the go-or-no decision. The costs of equipping a phase II trial with our solution are minimal compared to the expenses and resource commitments of a phase III trial.

Potential for Fewer Blood Draws

For path-setting trials: use adherence as a measure of plasma concentration, in order to reduce (but never replace) blood draw activities.

Reduce Post market Risk

Conclusions regarding the therapeutic dosage and side effects are often based on idealized adherence levels rather than real world levels. This can distort trial results and introduce risks that are only discovered post-market.

Fewer Participants, Same Power

Our solutions are low-cost insurance measure against “just missing” a primary endpoint. Once data is stratified by adherence, significance can emerge and save an enormously expensive trial. Read below to learn more.

Learn More about the Products
that Power our Solutions

Med-ic®

The original smart blister package. Breaking a blister records the time and location (i.e. “8:00 a.m.” and “Day 1, Morning”). Med-ic can be customized to work with any blister design and dose pattern.

eCap™

The superior smart cap. Unscrewing and removing the eCap records the opening time. Several diameter and threading options are available to fit all common bottle types.

CertiScan® Platform

Consumer-quality software for clinical trials. Securely store, analyze, and action the data from smart packaging and other adherence devices. The CertiScan Platform includes web portals, mobile apps, developer tools, and a secure, central cloud.

Did You Know?

Missing doses, taking extra doses, or taking doses at inconsistent times make it challenging to keep drug plasma levels within the desired therapeutic window. This can result in ineffectiveness due to inadequate plasma levels, or side effects due to elevated levels. Both have serious implications for the clinical trial decision-making process.

A phase II trial showed no difference between treatment and placebo groups according to the primary outcome analysis. But when the subjects were stratified by adherence, there was a highly significant treatment effect for the participants who actually took the drug as prescribed. The drug was subject to further assessment.

The FDA, through its Critical Path initiative, has expressed an interest in the application of new tools to clinical trials. Advanced PK/PD analysis based on medication adherence monitoring can be an integral part of this process.

ROI

Our experts have modelled the relationship between statistical power, sample size and medication adherence.

Their findings? For every 1% adherence increase, there can be a 2% reduction in trial size (N) while holding statistical power constant.

Considering that many trials currently only reach 50% adherence, there’s lots of room for improvement – and tremendous ROI.

Direct Savings from Reduced N

Processing a participant is expensive. Requiring a smaller sample size could amount to millions of dollars in savings.

Additional Weeks of Patent Protection

Smaller N means a faster trial, potentially by months. This could amount to tens of millions of dollars in additional revenue.

Additional Weeks of Patent Protection

Smaller N means a faster trial, potentially by months. This could amount to tens of millions of dollars in additional revenue.

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