We develop custom solutions for Central Nervous System & Neurology clinical studies and Phase I-IV Clinical Trials.
Our experience in CNS & Neurology clinical trials includes ePRO and IVR/IWR, Randomization & Trial Supply Management (RTSM),
Clinical Trial Material Management (CTM) and other essential study services.
| Client | Indication | Phase | Description | Countries | Sites | Subjects |
| Large Biotech | Major Depressive Disorder (MDD) | II | Real-time calculations of pre-randomization diary questionnaire responses for inclusion to randomization, spanning 25 sites. | USA | 25 | 130 |
| Large Biotech | Chronic Stable Schizophrenia (CSS) | I | Subject IVRS to record medication dosing confirmation, in phase I, 46 subject study. | USA | 1 | 46 |
| Consumer Products Company | Mentholated Cigarette Biomarkers | N/A | Randomization, single-blind, parallel-group, multi-center controlled clinical study evaluating biomarkers of tobacco products exposures. | USA | 10 | 480 |
| Consumer Products Company | eVapor Cigarette Biomarkers | N/A | 10 site, 450 subjects in USA study to evaluate changes in biomarkers of cigarette smoke exposure when smokers switched to e-vapor products. Site web-based randomization. | USA | 10 | 450 |
| Biopharma | Complex Regional Pain Syndrome (CRPS), a.k.a. Reflex Sympathetic Dystrophy Syndrome (RSDS) | III | Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CTM Administered Orally, in 290 subjects over 46 sites. Subject self-registration mechanism to choose language. BYOD (smartphones, tablets, PC) web-based and Voice phone ePRO, collecting symptoms (0-10 pain scale) and medication dosing. Written English and Spanish, also including native UK, Australian and French Canadian voice talent. | UK, USA, Australia, Canada | 46 | 190 |
| Biopharma | Knee Pain | III | Site users access web URL, workflow provided client’s choice of scheduled or manually pulled subject registration from EDC for subject IWR/IMR/IVR modality pain and medication dosing diary. Subject self-registration to diary, automatic diary language and voicing according to site location and subject primary language chosen. Reporting and data export on demand for study personnel. | USA, Australia | 61 | 345 |
| Specialty Pharma | Restless Leg Syndrome (RLS) | II | Site web-based RTSM, dispensing titrated drug based on data collected at each of 7 visits. | USA | 41 | 240 |
| Specialty Pharma | Parkinson’s Disease | II | CNS Study with 15 US sites and 60 subjects, managing screening and RTSM activities collected and implemented by Site IRT system. Two way data sharing with EDC system final database. | USA | 15 | 60 |
Contact us to discuss how our team can help you overcome study challenges.
Together, let’s make your next project a success.
