Home∕CRO Services∕Ethics Mangement Ethics Management Lotus Clinical Research provides ethics committee documentation services for sponsors. ETHICS MANGEMENT Lotus Clinical Research provides ethics committee documentation services for sponsors. Our teams draw from extensive internal resources to provide the following services: Quality review of startup documents Essential regulatory document collection from participating clinical trial sites Safety reporting Trial Master File (TMF) services CONTACT FOR INQUIRIES Our Analgesic Expertise Learn More We are analgesic experts with a proven track record of conducting successful, full-service analgesic studies from startup through all phases of analgesic clinical trials. Learn more about our best-in-class capabilities, tools, and techniques. CRO SERVICES SITE SERVICES PLACEBO RESPONSE MITIGATION ANALGESIC EXPERTISE RESOURCE WHO WE ARE Participate in Trial Contact Us Terms of Use Privacy Policy © 2021 Lotus Clinical Research, LLC. All Rights Reserved.

Home∕Analgesic Expertise∕Early Phase Early Phase Phase 1 and Analgesic Proof-of-Concept Lotus Clinical Research’s patient training tools and data collection methodologies result in reduced variability and improved statistical sensitivity toward the primary efficacy endpoint. Multi-Day Confinement, Pharmacokinetic and CSF Collection Lotus Clinical Research has the ability to house analgesic and surgical patients for up to 30 days in order to: Collect pharmacokinetic and CSF samples Control study confounders and monitor diary data Ensure medication compliance Maintain strictly regimented diet plans Closely observe for safety Located Within A 675-Bed Multispecialty Community Hospital Lotus Clinical Research operates a 40-bed phase 1 unit located within a community hospital, providing our clients with unprecedented access to medical subspecialists and technological resources. The emergency room is 100 yards away and the hospital code team will respond to our unit conferring an additional layer of safety to our subjects. Contracts Independently and Utilizes Central IRB Although Lotus Clinical Research is located inside a hospital, it is an independent business unit which means that it can utilize a central IRB and execute contracts independently from the hospital. This results in rapid study starts that are not tied to the institutional bureaucracy typical of other hospital-based units. Contemporaneous Pharmacokinetic/Pharmacodynamic Assessments The Lotus Clinical Research phase 1 team is skilled in pharmacokinetic assessment and processing. All staff who handle blood products are IATA certified. The unit is equipped with a refrigerated centrifuge and minus 70-degree freezer. Double Stopwatch Technique Our staff has extensive experience with the double stopwatch methodology. Subjects are trained with our proprietary tools to understand the difference between perceptible and meaningful relief. CRO SERVICES SITE SERVICES PLACEBO RESPONSE MITIGATION ANALGESIC EXPERTISE RESOURCE WHO WE ARE Participate in Trial Contact Us Terms of Use Privacy Policy © 2021 Lotus Clinical Research, LLC. All Rights Reserved.