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
  • Hepatic Impaired
  • Renal Insufficiency
  • Diabetes
  • Adult and Elderly
  • Pain
  • Addiction
  • Low Testosterone
  • NASH
  • Obesity
  • Post-Menopausal
  • Sexual Dysfunction