Our team includes investigators with decades of pain management clinical experience and advanced degree-level raters who receive comprehensive and consistent training for performing pain scales before and throughout study execution. All site staff continually participate in training sessions on placebo response factors and systemic strategies to mitigate the placebo and nocebo effect.
Apex’s Scientific Affairs and Clinical Development team is well known for its work in pain management. With executives with extensive experience leading clinical development programs in pain management from a Sponsor, CRO, and site perspective, it offers thought leader expertise in protocol development and program planning from pre-IND to NDA. Our large subject databases and referral relationships with large medical practices and other organizations grant us excellent access to chronic pain patient populations. We have consistently achieved and overachieved recruitment targets in pain management studies.
- Abdominal Pain
- Chronic Pain Disorders
- Cancer Pain
- Neuropathic Pain
- Lower Back Pain
Specialized Services and Capabilities
- Inpatient units with separate areas for healthy volunteers and patient populations
- Adaptive trial designs
- Pain models in healthy volunteers and patient populations
- Comprehensive experience with electronic clinical outcome assessment (eCOA) systems
- Integration of complex pharmacodynamic (PD) assessments that may include neuroimaging and electrophysiology methods (standardized PD procedures across our Apex sites)
- Inclusion of patient populations in early phase clinical development plans (e.g., Phase I SAD/MAD studies)
We have an outstanding track record of success in the conduct of Phase I-IV trials across the central nervous system and internal medicine disorders.