Vaccines

With a vast educational background and extensive on-the-job training and experience in the pharmaceutical industry, the staff at 4Clinics offers considerable expertise in the clinical, observational, and epidemiological studies of vaccines and immunotherapeutics.

  • Proven experience across prophylactic vaccines – seasonal flu, H1N1, H5N1, H9N2, H7N9, anthrax, plague, smallpox, meningitis, herpes zoster, dengue, hepatitis B and C, DTP, typhoid, HPV, tuberculosis, IPV
  • Proven experience with therapeutic vaccines
  • Familiarity with all routes of administration – oral (pill/liquid), intramuscular, intradermal, transdermal and intranasal
  • Proven experience across different populations – adult, pediatric, elderly, niche, at-risk, and therapeutic populations
  • Preferred network relationships – 4Clinics is able to leverage extensive and long-standing preferred relationships with a strong network of high-performing study sites, investigation centers with specialized knowledge in operational development, and CROs to position your development strategy and protocol for success.
  • Proven experience in protocol development for vaccine studies
  • Proven experience in statistical analysis and methodologies for clinical and epidemiological studies.

Immunology and Immuno-oncology

4Clinics offers considerable expertise in clinical and observational studies of immunotherapeutics.

  • Proven experience across immune-mediated pathologies like :
    • Allergy
    • Auto-immune diseases
  • Proven experience with immunotherapies in oncology
  • Proven experience with therapeutic vaccines
  • Preferred network relationships - 4Clinics is able to leverage extensive and long- standing preferred relationships with a strong network of study sites, investigation centers, and CROs to support your development strategy
  • Proven experience in statistical analysis and methodologies needed for immunology studies and endpoints

Cell Therapy & Regenerative Medicine

Our experience with Phase I-III trials in these areas gives us considerable insight into overcoming the specific challenges of developing these unique products. Our capabilities allow us to offer our clients :

  • Highly skilled support in all clinical operations and biometry activities unique to cell therapies and regenerative medicine
  • Access to partners and investigation centers specialized in regenerative medicine
  • Biometry and medical writing platforms with strong experience in cell therapy and regenerative medicine, including DSMB and IDMC management.