Optimum emphasis on the ethical aspects of clinical trials manifests commitment towards mankind and society. Auriga Research Limited (ARL) team understands the importance of managing the accuracy and quality of data in clinical trials. ARL team ensures clinical data accuracy and integrity by thorough review of the data to assess the validity of outlying data points and careful document query identification & resolution throughout the study duration. Quality assurance Unit (QAU) performs periodic operational checks to make sure trial related activities, were appropriately conducted and that the data were generated, recorded, analyzed and accurately reported according to protocol, standard operating procedures (SOPs), and good clinical practices (GCPs).
Monitoring & assistance for all the functions & phases for trial in India that includes:
- Identifying, Initiating & performing monitoring at sites with feasibility studies
- Draft study specific SOPs & Documentation
- Protocol Planning & Development
- Presentation of Protocol at IEC Meeting
- Designing of Case Record Forms (CRFs), Informed Consent Forms (ICFs), CIB ,Patient diary & Investigator Manuals
- Trial Registration, Regulatory Approvals including documents preparation
- Site selection & feasibility
- Investigators & Staff Training on Prtocol & GCP Guideline
- Safety Management including Adverse events / Serious adverse events
- Safety monitoring supervised by medical monitor
- Source Data Verification at sites by detailed monitoring plan and execution
- Reporting of safety information to all stakeholders at specified time interval
- Monitoring at site intiation, interim and close out of site
- Negotiate and prepare contracts and budgets
- Preparation of final study reports
- Conduting QA Audit by trained professionals
ARL provides complete clinical trial solution starting from site and investigator selection, trial conduct, monitoring, logistics, compilation of final reports etc. Expertise includes various therapeutic areas like Cardiovascular, Anti-Viral, Respiratory, Diabetes, Medical Device, Vaccine, Cosmetic and Diabetes.
