Investigator / Site Services
“Haxon coordinates with you to organize, conduct and complete successful clinical trials & refers to a range of support activities provided to researchers, clinical investigators, and study sites involved in clinical trials and research studies. These services are designed to facilitate the efficient and effective conduct of research, ensure compliance with regulatory requirements, and support the needs of investigators and study sites throughout the duration of a study.
Types of Investigator / Site Services
- Complete literature review and meta-analysis
- Statistical planning (sample size estimation, randomization, and power calculations)
- Case Report Form (CRF) design and guidelines to fill-in
Informed consent form (ICF)
- Site feasibility studies
- Site selection and evaluation
- Collection of essential documents
- Investigators’ meetings
- Documentation procedures, such as Trial Master File Management, central investigator file and investigator site file
Investigator Grants Management
- Staffing with trained and experienced CRCs
- Patient recruitment support
- Investigational Product (IP) Management
- Training on IP, lab handling procedures, ECG, etc.
- Logistics management
- Site specific Standard Operating Procedures (SOP's)
- On-site developmental briefing of Investigators and research team
- Customized Programs in:
- Working and interacting with Regulatory Authorities.
- Effective informed consent processes for subjects
- Regulatory document preparation and maintenance
- Current industry standards (GCP, GLP - Maintenance of CRFs, Informed Consent Forms (ICF) and study logs
- Drug accountability and central laboratory Interactive Voice Response System (IVRS) and ECG procedures
- Preparation for audits
- Business Development of the Site and its capabilities
- Notification of upcoming research trials and opportunities
- Provide expertise in customized budget preparation
- Ethics committee approval, DCGI clearance
- Patient follow up
- Tracking CRFs
- Regulatory compliance
- Site Quality Assurance
- Maintenance of Site documents
- Resolution of queries
- Research site liaison
- Progress and status reports
- Resolution of issues like Serious Adverse Event and DCFs within timelines
- Patient follow up
- Tracking CRFs
- Regulatory compliance
- Site Quality Assurance
- Maintenance of Site documents
- Resolution of queries
- Research site liaison
- Progress and status reports
- Resolution of issues like Serious Adverse Event and DCFs within timelines
- Precise and accurate data entry method, data validation, data analysis, data resolution and storage.
- Maintaining of accuracy, integrity and confidentiality at every stage of the clinical trial.
- Supporting EDC