Preclinical

  • Toxicology Testing: Analysis of contaminants, toxins and prohibited substances
  • Purity Testing: Evaluation of the investigative biomedical entity to ensure that it contains the requisite compounds at the indicated quantity and of the right quality.
  • Dosing: Determination of the right quantity for the administration of the investigative compound

Clinical

Based on requirements, we offer flexible clinical trial management approaches to meet the study-specific needs of our partners. We utilize our robust network of sites and investigators to deliver comprehensive clinical study management services to include

  • Study feasibility
  • Study design, initiation, conduct, and close-out
  • Budget development
  • Risk Management
  • Study documents development and translation
  • Site feasibility, qualification and management
  • Site and Study Monitoring
  • Auditing
  • Evaluation of diagnostics

Regulatory Affairs

Navigating regulatory submissions tailored to specific regional requirements sometimes can become a complex and time-consuming process. We provide regulatory strategies and operational support to streamline and expedite the clinical validation and market access for new medical products in the African region. We offer the following:

  • Liaison with requisite regulatory authorities
  • Guidance on drafting documents in designated templates
  • Dossier submissions and follow-up
  • Regulatory report writing/updates

Pharmacovigilance/Post-market Surveillance

We understand the importance of tracking the safety of developmental and marketed medical products, as such information is critical to the wellbeing of the public and post-approval license renewals. We cover the following:

  • Medical assessment and literature review
  • Profiling of investigative entity (biochemical or otherwise)
  • Case processing
  • Development of Pharmacovigilance documents
  • Management of Pharmacovigilance Master File

Literary

We support the development of scientific literatures for the conduct of medical research:

  • Medical Writing
  • Health Writing
  • Proof-reading

Vendor Management

We are experienced in the coordination and management of vendors whose clinical study activities can be outsourced to. A few of this services include:

  • Vendor Feasibility and Selection
  • Clinical Staff Sourcing
  • Clinical Trial Laboratory Management
  • Pharmaceutical Storage Management

Training and Mentorship

Clinical Research training is crucial for cultivating a continuous cohort of proficient clinical research professionals. This helps in upholding ethical standards, ensuring research quality, promoting participant safety, complying with regulations, advancing medical knowledge, and fostering career development within the industry. Utano CRO provides the following training types:

  • Ethics in Medical Research
  • Good Clinical Practice
  • Participants Data Protection
  • General Clinical Research Training
  • Pharmacovigilance
  • Clinical Research Coordinator (CRC) and Clinical Research Associates (CRA) Training
  • Internship

Study types

Study Types

  • Phase I, II, III, & IV clinical trials
  • Medical Device Studies
  • Epidemiology Studies
  • Observational Studies
  • Registry and Post-market Studies

Therapeutic Areas

  • Infectious Diseases, Cardiovascular, Hematology, Immunology and Rheumatology, Oncology, Dermatology, Respiratory, Women’s Health, Pediatrics, Rare Diseases