C.i.t.o

Clinical Trial Services

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Clinical Trial Services

Over the last 15 Years we made an impact that is strong in pharma industry.

Cito’s Clinical Development Services comprises of various services such as Bioavailability/Bioequivalence studies, Clinical Trials and allied supporting services for the pharmaceutical industry for their submission to regulated and semi regulated market. Having a basket of associates, Cito is uniquely structured to support the needs of healthcare industry during all stages of clinical development, whether be a complete bioequivalence study or a clinical trial management program. We are capable to provide you assured quality to answer your clinical need.

We organize for our associates various pre-clinical and Clinical Development Services.

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Clinical Trial

Pre-clinical

Expected studies on toxicity and others on small animals, large animals both in GLP and non-GLP environments.

Clinical Trial

Early Stages

Phase-I for those products manufactured in India Phase-I from Second cohort on-wards for those products manufactured outside of India.  BA/BE studies on both healthy and patient populations

Pre-Clinical BA/BE studies Phase II-IV

 

  • Acute
  • SubAcute
  • Sub Chronic And Cronic
  • Reproductive And Development Toxicity
  • Genetictox
  • Immunotoxicology
  • Efficacy Models
  • Physical Chemistry
  • Ecotoxicity
  • Infectious Models
  • Routes Of Administration
  • Biological Tests

 

  • Dose Linearity Studies including dose escalations
  • Multiple Dose and Steady State
  • Fasting
  • Food Effect
  • Drug Drug Interactions

 

  • Design & Implementation of Clinical Phases
  • Clinical Trial Operations (Site Initiation, Monitoring and Closeout)
  • Investigator Site Selection
  • -- Clinical Trial Supplies Management
  • Site Management
  • Analysis & Interpretation of Healthy subjects & Patients studies
  • -- Project Management (Start to End)
  • -- Clinical Safety (PSUR and safety Reports)
  • -- Clinical Study Monitoring, Auditing & Training
  • Regulatory Consulting
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