Early Phase
Clinical Development Services
Get the EARLY ADVANTAGE
Over 50% of our Experience is in Early Phase
Explore and advance your promising compound with comprehensive Phase I and clinical pharmacology services from Lotus. Our team of experienced experts, access to healthy volunteers and patient populations, and purpose-built clinical pharmacology units give you the early advantage.
Phase I Studies
Studies with Normal Healthy Volunteers
Database of Normal Healthy Volunteers
Dedicated Beds for
Early Phase Research
Statistics combine experience from both Lotus Clinical Research and Evolution Research Group’s network of clinical research sites.
Dedicated Phase I Units
Two custom-designed sites designed to deliver safe, precise, well-controlled clinical research
Rapid Study Start-up
Access thousands of pre-screened healthy volunteers and patient populations across a multitude of indications
Renal & Hepatic
Demonstrated Expertise Across Multiple Study Designs
Our Phase I and clinical pharmacology services are tailored to your program’s needs, from complex study designs to early signal detection.
With expertise in Phase I–IIa trials, including First-in-Human studies in both patients and healthy volunteers, Lotus delivers efficient, effective clinical research to support our Sponsors.
Our experience includes:
- Ascending Dose Cohorts (SAD/MAD)
- Bioavailability (Absolute and Relative BA) and Bioequivalence (BE)
- Cardiac Safety, Thorough QT/QTc
- Drug-Drug Interaction (DDI)
- Ethyl Alcohol Interaction
- First-to-File
- First-in-Human
- Food Effect
- Patch Irritability
- Pharmacokinetic / Pharmacodynamics (PK/PD)
- Proof-of-Concept/Proof-of-Mechanism
- Renal Insufficiency
- Hepatic Impairment
- Tasting
- Abuse Liability
Rapid Enrollment
Healthy Volunteers and Patient Populations
Fast access to healthy volunteers and special patient populations can critically impact the success of your study—we routinely take just weeks to initiate a study from contract execution to first-patient-in (FPI).
In addition to our robust database of normal healthy volunteers, we can access special populations including:
- Hepatically Impaired
- Renal Insufficiency
- Diabetes
- Obesity
- MASH/MAFLD
- Women’s Health
- Post-menopausal Females
- Age, Gender, and Elderly
- Low Testosterone
Ask us about our industry leading enrollment guarantee.
Drug Administration
Our expert teams can administer drugs in numerous ways including:
- Oral
- Intranasal/inhalation
- Intravenous (IV)
- Intramuscular (IM)
- Subcutaneous (SC)
- Transdermal/topical
- Tasting
- NG tube
Specialized Testing
Many early phase studies in neuroscience and metabolic clinical development require specialized testing. With comprehensive services and capabilities, some of our specialized testing includes:
- Imaging (MRI, ultrasound, x-ray, DEXA scan)
- Biopsy
- FibroScan
- Cerebrospinal Fluid (CSF) sampling
- Metabolic clamps, e.g. euglycemic clamps, etc.
- Tracer methodology / Isotopic labelling
- Oral Glucose Tolerance Test (OGTT) and Mixed Meal Tolerance Test (MMTT)
- Electroencephalogram (EEG)
Introducing NeuroKit®
A mobile, plug-and-play alternative to traditional CNS testing tools.
