Healthy Normal Volunteer / Early Development Services
Early Development Services for early-stage pharma and biotech clients
Lotus’ specialty Early Development Services (EDS) group was formed in 2020 to meet the need of our early-stage pharma and biotech clients. Our EDS team members work exclusively in early phase drug development and tailor services to meet the unique needs of these critical studies. They bring the specific study planning and clinical execution expertise across the following types of phase trials:
Ascending Dose Cohorts (SAD/MAD)
BA/BE
Drug Interaction (DDI)
Cardiac Safety/TQT/QTc
Renal and Hepatic
Impairment
PK/PD studies
Food Effect
First in human
First to File
Specialties populations include:
Tobacco Users
Recreational drug users for assessment of abuse potential