EXPERTISE
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, HIV, HPV, RSV, CMV, Ebola, Zika, Smallpox, Meningitis, Herpes Zoster, Dengue, Hepatitis B and C, DTP, 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
MEDICAL DEVICES & REGENERATIVE MEDICINE
Our experience 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 :
- Full services for PoC, feasibility, safety, CE mark and PMCF studies from synopsis to report including legal and operational support for medical device studies
- Highly skilled support in all clinical operations, regulatory affairs, medical writing and biometry activities unique to medical devices studies
- Access to partners and investigation centers specialized in regenerative medicine
- Biometry and medical writing platforms with strong experience in gene therapy, cell therapy and regenerative medicine, including DSMB and IDMC management.