Tailored Solutions for Pain-Related Clinical Trials
Maximizing Clinical Trial Success with the Power of Thermal QST
In the face of ever-increasing complexity of clinical trials for the treatment of pain, targeting the right patient population is of paramount importance to the trial’s success. Rather than rely on general traits or qualitative measures of pain, employing thermal Quantitative Sensory Testing (QST) methods offers precise, reliable data for selecting those patients with the highest likelihood of response to treatment- optimizing the trial and maximizing the chances it will succeed.
Medoc offers neuro-diagnostic testing systems of small sensory nerve fibers and pain mechanism function using Quantitative Sensory Testing (QST) and Contact Heat Evoked Potential (CHEPS) techniques. These methods determine the pain and sensation thresholds for cold and warm temperatures as well as vibration sensation thresholds by stimulating the nerve endings of the skin and comparing the results to normative values of healthy nerve endings.
QST Expertise for Trial Success
Utilizing the powerful neuro-diagnostic capabilities of Medoc’s devices in the early phases of pain clinical trials contributes significantly to the development of an optimal, robust study design for the pivotal trials, maximizing the chances that they will succeed and that your pain solution will reach the commercial market.
All-Phase Trial Advantages
Medoc’s devices have been utilized and integrated into all phases of clinical trials. In Phase I studies, Medoc devices are used to assess the analgesic effects of treatment based on subjects’ responses to experimental pain models. These are used to produce first-in-human early efficacy measures. Medoc devices are also commonly used in both Phase II and III studies at baseline, to phenotype subjects for inclusion based on specific characteristics as predictors of treatment response.
- Early design phase support- including research and guidelines
- Recommendations for advanced QST test batteries and trial end-points
- Streamlined, Plug & Play solutions- without time-consuming set-up procedures or complex operation.
- Customized software- to trial-specific protocols with the ability to generate customized reports.
- Training- covering all essentials of clinical trial performance, monitoring and protocol execution.
- Ongoing, Comprehensive Support
Q-Sense and Q-Sense CPM
Q-Sense is a portable, easy-to-use system offering scientifically validated measures of warm, cool and heat-pain thermal sensory thresholds- all clinically useful determinants in the evaluation and monitoring of small- fiber neuropathies and neuropathic pain.
Q-Sense CPM (Conditioned Pain Modulation) expands the testing scope of Q-Sense with an additional thermode within the same, lightweight system. This allows for the evaluation of multiple stimuli in more complex testing protocols as well as the ability to conduct both static and dynamic Quantitative Sensory testing.
Mr. Tal Bornstein, QST Division Manager, commented on Medoc’s recent expansion: “With vast experience in medical research, advanced technologies and creative solutions to complex trial challenges, Medoc is the perfect partner for CROs looking to optimize their pain-related clinical trials anywhere in the world.”