Our team of experts understands the many unexpected complications in ultimately achieving regulatory approval. We’re able to deconstruct problems others miss, and utilize innovative tools and techniques to lead clinical trials over the finish line.
We have been involved with most successful analgesic drug development programs and studies. Our consulting services have been provided to nearly every company developing analgesics, spanning early stage startup companies to top 3 pharmaceutical companies. Analgesic Solutions’ long standing track record of successful collaborations with regulatory authorities can assist our clients in development and execution of their drug development strategy for regulatory approval.
We have demonstrated that the less able the patient is to communicate their pain, the less likely the efficacy of the drug compared to placebo will be demonstrated. Accurate trials are about clean clinical data, and a well designed trial will deliver better results. Gain an edge with our innovative approach and research tools.
Analgesic Solutions’ Training programs have been applied in many clinical trials, with a recent multi-national program consisting of 4 clinical studies across 17 countries, 19 languages, 200 clinical sites, and 2500 patients.
The patient’s expectation of analgesia is the major driver of the placebo response. Several studies have shown that intentional “neutralization” of patient expectation can reduce the placebo response.
Pain is inherently subjective, and a common flaw in clinical trials is the lack of training provided to subjects on how they can more accurately report their pain.
Improve the likelihood of bringing pain medicines to market with Analgesic Solutions’ proprietary research tools. Our FAST (Focused Analgesia Selection Test) is currently applied in an FDA approved, 25 clinical site, phase 3 pivotal trial as a method to exclude poor pain reporters.
Studies have demonstrated that excluding poor pain reporters improves drug effect sizes, and reduces the number of required patients in clinical trial. Analgesic Solutions has demonstrated and confirmed that patients' FAST scores predicted their ability for discrimination of naproxen from placebo.
Supporting clinical trials by creating sub-groups of patients for targeting treatment efficacy.
Screening technology based on affecting baseline pain reporting.
This instrument can be utilized to efficiently and systematically evaluate foot pain and exclude patients with disorders that “masquerade” as PDN.
Small Fiber Neurological Testing is an examination that allows quantification of small fiber function. It may be used at screening, endpoint, or both, depending on the specific study. This tool can be especially useful in clinical trials evaluating neuropathic pain treatment candidates.
Once the problem is visualized and classified, then the underlying solution is defined. We marry the solution to the cause of the problem to create successful outcomes.
In a sense, QDSS is your X-Ray Vision during the conduct of your clinical trial, your chance to ‘look under the hood’. We utilize sophisticated Statistical Process Control (SPC) techniques to identify statistically significant aberrant signals in performance of clinical sites and patients in near real time before they become irreversible or cause costly damage. Analgesic Solutions defines the nature of the problem and clearly lays out specific interventions. Read More
Some solutions are custom designed, and at other times our proprietary solutions are a perfect fit, where the focus is then on implementation and efficiencies. If something is off course in the clinical trial or there’s a concern that something may need intervention/improvement, QDSS is the remedy.
Until recently there has been a critical gap in measuring potential abuse liability of drugs in clinical trials. Previously, there existed no standardized method to demonstrate if a drug was less abused than others. The FDA needed a system to show the potential for abuse, and Analgesic Solutions had the answer.
The MADDERS™ system was developed in collaboration with the FDA-ACTTION initiative to fill a need for standardized approaches to measure abuse in clinical trials and was presented to the FDA.
MADDERS™ system aids in generation of relatively low abuse potential to support approval, labeling, and scheduling decisions. It is supported by several publications and has been applied to four clinical trials, and currently implemented for a program consisting of 3 clinical trials.
Analgesic Solutions has an onsite clinical research center for the purpose of developing and validating tools to improve clinical research. Customers often need a new questionnaire or measurement approach developed or validated for regulatory/scientific purposes quickly, to avoid delaying a drug development program. Analgesic Solutions can offer a series of solutions that fit their need.
We have developed an advanced suite of tools in our validation laboratory that is currently being used in clinical trials across the nation.
Analgesic Solutions can be hired as a clinical trial management team to maximize the effectiveness of our tools and techniques.
We are currently running a 25 site Phase III pivotal trial that in some ways is the first “modern” multicenter pain study. Read More
We partner with CROs to support implementation of our innovative tools for the study, and can act as your clinical trial management team as well.
There are advantages to having us manage your clinical trial: One-stop-shop to maximize the effectiveness of our tools and techniques, we are the best at implementing our own state-of-the-art research approaches. Whichever kind of pain study is being conducted, Analgesic Solutions has tools designed to fit the need.