PHASE 1 & ANALGESIC PROOF-OF-CONCEPT
Multi-day confinement, pharmacokinetic and CSF collection
Lotus 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 is an independent 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 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.
High-volume Low-Variability Acute Pain surgical models
By utilizing our acute pain recruited surgical model, Lotus decreases enrollment time and overall project cost substantially. Instead of recruiting acute pain patients in the conventional way, waiting for patients who have the condition of interest to present themselves to the hospital for surgery, Lotus actively recruits patients using newspaper, radio and television advertisements. Our location within a large metropolitan hospital gives us the ability to apply this model to multiple surgical indications and enroll an average of 8-10 patients per week. Project costs can be reduced by 30+% over a larger multicenter trial as a result of; less time for investigator recruitment and training, CRA travel, project management, etc. Read More.
The FDA often requires several days of study medication administration in order to support a multi-day claim. However, standard of care discharge for most surgical procedures is being shortened secondary to insurance reimbursement. Lotus has the ability to discharge patients from the hospital unit and transport them to our research center for multi-day confinement and study medication administration.