Clinical & Preclinical Trials
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The Clinical Division is a complete service provider to pharma companies with respect to assembling, managing, monitoring and reporting on pre clinical and clinical studies conducted at multiple geographic centers. |
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Clinical Trial Services Offered |
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- Selection of sites and investigators from geographical distributed areas as per
feasibility analysis
- Protocol, CRF, Informed consent form, Investigator's Brochures designing
- IRB & EC submissions
- Study initiation, Interim and study closure visit
- Clinical monitoring and Q.A. audits
- Biostatistics
- Preparation of Interim and final reports
- Source data validation
- Data review and query resolution
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Clinical Trial Services |
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- Pre Study
- Feasibility Analysis
- Selection of Principal Investigator
- Pre-site Selection Visits
- Investigator’s Brochures
- Development of Clinical Study Protocols & Synopsis
- Designing of CRFs and other trial related documents
- IRB & EC submission
- Study Management
- Site Initiation
- Regular monitoring visits to the sites to resolve queries related to data
- Informed Consent Admin Assistance
- Safety monitoring and serious adverse event reporting/ tracking/ follow up
- Checking internal consistency of CRF data
- Post Study
- Study closeout
- Report writing
- Statistical analysis
- 100 % source data validation
- Data review / data query management
- Therapeutic Focus & Experties
- Cardiovascular studies
- Respiratory studies
- Elderly studies
- Diabetology
- Pain management studies
- Ophthalmic studies
- Dermatological studies.
- Dental Studies
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Preclinical Trials |
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We Coordinate for following pre-clinical
Studies as per OECD Guidelines
- Sub-acute toxicity for API
- Ocular toxicity studies
- Eye Irritation studies
- Skin Irritation studies
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