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Investigator / Site Services |
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We are greatly obliged by you for taking an interest in Aurum Clinical Research to assist you for your site management for valuable clinical trials going or will be going under your guidance. |
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However the services we provide are site specific, following are some elements which are taken care by us. |
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Business Development : |
- Updating of upcoming research trials and opportunity
- Marketing and Business Development of your site.
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Trial Management : |
- Staffing with trained and experience CRC and other site staff like Pharmacist, Nursing staff etc.
- Various training program for the site development.
- Work with standard guidelines of current industry i.e. GCP & govt. ethics.
- Working and interacting with regulatory authorities.
- Protocol specific training.
- Effective ICF process for subject.
- Regulatory document preparation and maintenance.
- Maintaining CRF and study logs within time line.
- Communication with central laboratory.
- IVRS, IWRS, Central ECG and other protocol specific requirements.
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Site Management : |
- Independent protocol audits for QA and training purpose.
- Management and maintenance of site documents.
- Constant site monitoring.
- FDA and internal ( Sponsors / CRO Specific) inspection preparation.
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Data Management : |
- We are having precise and accurate data entry method, data validation, data analysis, data resolution as well as storage.
- We are bound to maintain accuracy, integrity and confidentiality at every stage of the clinical trial.
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Independent EC |