Phase 1 Inpatient
Flourish Research has the facilities, experience, and proven success with recruiting for Phase 1 Studies, including First-in-Human and Healthy Populations. Chief Medical Director of Flourish in San Antonio, Douglas Denham, DO, CPI has overseen more than 100 Phase 1 studies.
Finding the right clinical trial sites to meet enrollment timelines with high-quality data can be challenging.
Flourish Research takes the burden off of you. Our Phase 1 Inpatient site has conducted more than 89 studies, enrolling more than 1,500 patients. We have more than 8,000 healthy volunteers pre-identified in our database to enroll in studies.
Capabilities and Experience
- First-in-Human
- SAD/MAD
- PK/PD
- Insulin challenges
- Glucose challenges
- Glucose/Insulin manipulation
- Phase Ib/IIa in patient populations
- Lumbar punctures
- Infusions
- Certified FibroScan techs
- Bioequivalence
- Cardiac telemetry
- Full-service, onsite PBMC laboratories
- Outpatient Phase 1 trial experience at 7 locations
Therapeutic Experience
Patient Population
In addition to the study-specific training by the PIs, our Phase 1 study teams perform a mock run
Built for Efficiency and Excellence
At Flourish, our wholly-owned sites are harmonized and standardized (SOPs, training, Budgets & Contracts, start-up, quality management) to ensure data consistency and efficiencies between sites.
SOPs
Training
Quality Management
Budgets & Contracts
Early Phase Facilities & Equipment
- 57 inpatient beds
- Dedicated, secure overnight facilities
- Temperature data logging & phone alert system
- Synchronous Atomic Clocks
- Limited-access, temperature-controlled drug storage
- Ambient and refrigerated centrifuges
- Drug & specimen refrigerators
- -80°C and -20°C freezers
- ECG, with onsite interpretations
- EEG Procedures
- Spirometry
- Pharmacy hood
- Dietician-planned meals
- IV infusion dosing/monitoring
- YSI machines (Biochemistry Analyzer)
- eDocs, eRegulatory for 24/7 access of data
- Accommodations for sponsor/CROs for onsite observation of dosing/procedures
- Accredited sleep labs
- Backup generators
- Crash Carts
- eSource
Complex Inpatient Studies
Healthy volunteers:
- Recent healthy volunteer study randomized 33 in one month despite a complex schedule of a 6-day inpatient stay, followed by 8 consecutive outpatient visits, a 56-day washout, then repeat the 6 inpatient/8 outpatient-day series. Despite the complexity, the site had a retention rate of 88%. This study involved multiple PK and safety timepoints.
- Site has strategically grown the database of healthy volunteers to more than 8,000.
- Another healthy volunteer study randomized 72, but patients struggled with side effects from the treatment. Despite that challenge, the site maintained an 85% completion rate thanks to preparing the patient for the potential side effects during informed consent and developing strong patient relationships.
- Top Enrollers:
- CTT was a top enroller, despite being a rescue site in a recent Low-T study.
- Highest enroller in genetic NASH study, where the success was fueled by a robust NAFLD/NASH prescreening program.
Staff Experience
- Douglas Denham, DO, Chief Medical Director
- Dr. Denham has overseen more than 100 Phase 1 studies.
- Faisal A. Fakih, MD, Chief Medical Director
- Dr. Fakih has been involved with 20 Phase 1 studies.
- Parke Hedges, MD, Investigator
- Dr. Hedges has been involved with 20 Phase 1 studies.
- Parke Hedges, MD, Investigator
- Dr. Hedges has been involved with 20 Phase 1 studies.
- Mark Rosenthal, MD, Investigator
- Dr. Rosenthal has been involved with 4 Phase 1 studies.
- Barbara Corral, DNP, MSN, MA, FNP-BC, Director Early Phase Services (pictured, left)
- Dr. Corral has worked on more than 20 Phase 1 studies.
- Steven Schmid, PhD, Senior Director, Lab
- Dr. Schmid has more than 35 years’ of experience in drug discovery and development.
PBMC Onsite Processing
Flourish Research offers in-house PBMC (Peripheral Blood Mononuclear Cell) services to meet client needs for the evaluation of the cellular immune function within the clinical trial setting.
- Onsite processing eliminates the need for sample transport, which is a weak link in the process
- Network-wide SOPs and quality control
- Four labs supporting 8 sites across the U.S.
- Deliverable: high-yield, high-viability cryopreserved (PBMC) cells
Capabilities
- Temperature-controlled labs
- Isolation using Ficoll/CPT and/or other isolation techniques
- Class II A2 biosafety cabinets
- Fluorescent staining & image analysis
- Two-step cryopreservation process
- Long-term storage in vapor phase of liquid nitrogen at -135° C
Let’s talk
Contact us to find out more how Flourish Research can be a valuable partner in Early Phase Research
