1. Clinical Trials for Medical Devices
We conduct clinical investigations and post-market studies to assess safety, performance,
usability, and clinical benefits of medical devices in compliance with ISO 14155 and ICH-GCP
guidelines.
Includes:
- Pre-market & post-market clinical studies
- Usability and human factors studies
- Observational & comparative studies
- Site coordination & monitoring
- Clinical Study Report (CSR) preparation
2. Performance Evaluation of IVD Kits
Clinexiz specializes in performance evaluation studies for in-vitro diagnostic (IVD) kits
to demonstrate analytical and clinical performance.
Study Scope:
- Sensitivity and specificity evaluation
- Accuracy, precision & reproducibility
- Method comparison studies
- Stability and interference analysis
- Performance evaluation reports
3. Clinical Trials for Cosmetics
We provide cosmetic safety and efficacy studies to support regulatory compliance and marketing claims.
Includes:
- Dermatological safety assessment
- Skin irritation and compatibility testing
- Efficacy and claim substantiation studies
- User acceptance and tolerance studies
4. Clinical Research for Nutraceuticals
We design and execute clinical studies for nutraceutical and dietary supplement products
to validate safety, tolerability, and functional benefits.
Includes:
- Observational and controlled studies
- Safety and tolerability assessment
- Biomarker-based efficacy evaluation
- Scientific substantiation of claims
5. Regulatory Submission Services
We provide complete regulatory documentation support for clinical research and performance
evaluation submissions.
Services Include:
- Clinical documentation for regulatory authorities
- Ethics committee submission support
- Performance Evaluation Reports (PER)
- Clinical Evaluation documentation
- Post-market compliance support
6. Protocol Development
Our experts develop customized, scientifically sound protocols tailored to product type,
study objectives, and regulatory requirements.
Protocol Services:
- Study design & methodology
- Inclusion/exclusion criteria
- Endpoint definition
- Risk management & monitoring strategy
7. Biostatistics
We provide biostatistical support across all stages of clinical research.
Includes:
- Sample size calculation
- Statistical analysis plans
- Data interpretation
- Final statistical reports
8. GCP Training
Clinexiz conducts Good Clinical Practice (GCP) training programs for investigators,
clinical research staff, and organizations.
Training Covers:
- ICH-GCP principles
- Ethics and informed consent
- Roles and responsibilities
- Regulatory compliance
- Documentation and quality management
