Aurous HealthCare
Independent ISO 9001:2015 certified Contract Research Organization (CRO) based in Chennai, India, founded in 2008. Provides end-to-end clinical research services including clinical trial design and execution, regulatory submissions and ethics review support, medical writing, data management and statistical analysis, site management and rescue services, clinical trial supply management, and R&D activities (in vitro/toxicology and bioanalytical method development). Operates an independent ethics committee registered with national and international regulators. Has conducted clinical research across vaccines, medical devices, herbal/nutraceutical products, cosmetics, and traditional medicine systems.
Industries
Nr. of Employees
small (1-50)
Aurous HealthCare
Chennai, Tamil Nadu, India, Asia
Products
Clinical Trial Management
Provides end-to-end management of clinical trials including design, documentation, site selection, monitoring, patient recruitment, data management, and reporting.
Site Management and Rescue Services
Offers site feasibility, investigator selection, site training, monitoring, patient recruitment, and rescue services to support clinical trial sites and ensure study compliance and progress.
Medical Writing
Provides regulated medical writing services including preparation of clinical study protocols, informed consent documents, patient diaries, questionnaires, and regulatory submissions.
Commercial Positioning
Assists in the strategic positioning of healthcare products in the market, focusing on regulatory and clinical research aspects.
Regulatory Affairs
Supports regulatory submissions and compliance for clinical trials and healthcare products, including assistance with ethics committee approvals and regulatory authority interactions.
Clinical Trial Management
Provides end-to-end management of clinical trials including design, documentation, site selection, monitoring, patient recruitment, data management, and reporting.
Site Management and Rescue Services
Offers site feasibility, investigator selection, site training, monitoring, patient recruitment, and rescue services to support clinical trial sites and ensure study compliance and progress.
Medical Writing
Provides regulated medical writing services including preparation of clinical study protocols, informed consent documents, patient diaries, questionnaires, and regulatory submissions.
Commercial Positioning
Assists in the strategic positioning of healthcare products in the market, focusing on regulatory and clinical research aspects.
Regulatory Affairs
Supports regulatory submissions and compliance for clinical trials and healthcare products, including assistance with ethics committee approvals and regulatory authority interactions.
Services
Clinical Trial Management
End-to-end clinical trial services including design, site selection, monitoring, data management, statistical analysis and preparation of Clinical Study Reports.
Medical Writing
Authoring of regulatory and clinical documents such as study protocols, informed consent forms, patient materials and Clinical Study Reports.
Regulatory Affairs & Ethics Review Support
Support for regulatory approvals, trial registration and access to an independent ethics committee registered with national and international regulators.
Site Management & Rescue Services
Site feasibility, monitoring, co-monitoring, auditing, and rescue management services to address underperforming or problematic trials.
Commercial Positioning and Market-Focused Study Design
Design of clinical assessments and study reports to support product differentiation, marketing claims and product placement strategies.
Bioanalytical and R&D Services
In vitro analyses, toxicology studies, bioanalytical method development and validation (including LC-MS/MS) to support product safety and pharmacokinetic evaluations.
Clinical Trial Management
End-to-end clinical trial services including design, site selection, monitoring, data management, statistical analysis and preparation of Clinical Study Reports.
Medical Writing
Authoring of regulatory and clinical documents such as study protocols, informed consent forms, patient materials and Clinical Study Reports.
Regulatory Affairs & Ethics Review Support
Support for regulatory approvals, trial registration and access to an independent ethics committee registered with national and international regulators.
Site Management & Rescue Services
Site feasibility, monitoring, co-monitoring, auditing, and rescue management services to address underperforming or problematic trials.
Commercial Positioning and Market-Focused Study Design
Design of clinical assessments and study reports to support product differentiation, marketing claims and product placement strategies.
Bioanalytical and R&D Services
In vitro analyses, toxicology studies, bioanalytical method development and validation (including LC-MS/MS) to support product safety and pharmacokinetic evaluations.
Expertise Areas
- Clinical trial management
- Protocol development and clinical documentation
- Medical writing
- Regulatory compliance and submissions
Key Technologies
- Statistical analysis using SAS
- LC-MS/MS bioanalytical methods
- Randomized double-blind clinical trial methodology
- Bioanalytical method validation