Advancing Analgesic Development With Validated Pain Models
Validated Pain Models for Early-Phase Trials
Altasciences has over two decades of experience in analgesic drug development and pain modeling, including physical dependency and abuse potential assessments. Our highly skilled pain experts and neuroscientists assist you in selecting the most appropriate pain models to successfully evaluate the efficacy and safety profile of your study drug.
Consult our Pain Model Fact Sheet
How We Help Advance Your Pain Therapeutic
Pain models serve as a useful tool to model various types of pain, such as nociceptive and neuropathic. Altasciences uses such models in early-phase research, translating the models from preclinical assessment to clinical testing to characterize a dose-response relationship for a novel analgesic.
At Altasciences, pain models for analgesic drug development are typically conducted in normal healthy participants but can also be assessed in pain patients. Identifying the appropriate model for your novel analgesic is a critical first step. Successful designs require careful consideration of reproducibility, consistency, use of baseline measures and controls. Pain modeling uses various types of stimulation, including mechanical, thermal, chemical, and electric, each with distinct endpoints, mechanisms of action, and responsiveness to analgesic drug classes.
Altasciences is experienced with, and conducts studies in, different pain models, including:
- Cold Pressor Test
- Von Frey (manual and electronic)
- Thermal Probes
- UVB
- Capsaicin
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Barostat Method
- Staircase Challenge
Biomarkers may also be included to further characterize your compound. We can assist in determining the best approaches depending on the mechanism of action of your analgesic.
Standardization of Methods
Our successful implementation and execution of pain models depends on strict attention to operating procedures to ensure the reproducibility and consistency of results. Our standardized methods, based on best practices, are critical to reducing variability between tests and study participants. We test and validate all methods to deliver consistent stimuli and ensure they operate within a safe capacity for participants.
We align our operating procedures with published and validated research models. We maintain a robust training program for both staff and participants to ensure consistent application and reduce variability.
Integrated Service Offering for Analgesic Drug Development
In addition to pain models, our team of experts will guide you across the many unique opportunities and challenges in analgesic research. If your program requires expertise in any early-phase analgesic drug development service, we can help you navigate
- Proof of concept
- First-in-human—single and multiple ascending dose
- Opioid blockade (antagonist)
- Drug-drug interaction
- Abuse and/or dependency assessment
- Pharmacokinetic (PK)/Pharmacodynamic (PD) evaluation
- Phase II dose-ranging studies of safety and efficacy
- Regulatory support and strategic planning for this potentially complex therapeutic area
We support your analgesic drug development with complex and adaptive study designs, including enrichment phases to control for variability in outcome measures. To complement our in-house expertise, we partner with Cambridge Cognition and Medoc Advanced Medical Systems, two organizations renowned in the field of CNS testing. We also collaborate with a highly experienced knee surgeon for study setup and endpoint evaluation.
We offer expert project management for multi-site trials, including training sites on recruitment and/or pain models to achieve high inter-rater agreement.
Rapid and Efficient Recruitment for Analgesic Drug Development
Recruiting and retaining participants for pain model studies involves thorough screening and selection, comprehensive training on the completion of pharmacodynamic assessments, and provision of a safe and comfortable environment. At Altasciences, we engage, train, and retain, to ensure that healthy normal participants have the necessary understanding of trial procedures. Planning for these activities is critical to deliver and retain full panels, which supports timely study conduct and robust data collection.
If pain patients are required for your study, we have access to a network of hospitals and clinics to successfully recruit full patient panels.
Turnkey Solutions for Analgesic Drug Development
We offer a turnkey solution for pain studies in healthy normal volunteers, handling every aspect of your trial from start to finish.
Whether starting from scratch or refining an existing protocol, our team of clinical experts will ensure we streamline the process to support informed decision-making and meet your critical study milestones. With our deep understanding of analgesic studies and early-phase clinical trials, we ensure comprehensive, regulatory-compliant study design. We tailor protocols to meet the specific requirements of custom studies, focusing on efficient timelines and precise data collection.
Our three state-of-the-art clinics across North America are fully equipped to run your analgesic drug development study, with expert teams managing dosing, sampling, and pain model applications.
Real-time tracking of PK/PD data, safety assessments, and adverse event reporting ensures compliance with regulatory requirements and maintains data integrity throughout your trial.
Our state-of-the-art, co-located bioanalytical labs are equipped with a wide range of assays, ensuring precise and timely PK data, biomarkers of inflammation, and other endpoints as appropriate. We also have expertise in flow cytometry for your analgesic drug development. Leveraging these established methods, we provide the reliable data you need to meet regulatory standards, enabling faster decision-making and providing comprehensive label information.
We handle data management, analysis, and comprehensive reporting to deliver timely, high-quality results to satisfy stringent regulatory requirements.
Need support navigating regulatory requirements? Our experts can assist with a detailed plan for your preliminary pain studies.
At Altasciences, we ensure your analgesic drug study is fully enrolled, expertly conducted, and delivers accurate data on time.