Optimum emphasis on the ethical aspects of clinical trials transmits commitment towards mankind and society. Auriga Research Limited (ARL) team understands the importance of managing the accuracy and quality of data in clinical trials. We ensure clinical data accuracy and integrity by thorough review of the data, to assess the validity of outlying data points, and to carefully document query identification and resolution throughout a study’s duration. Quality assurance Unit (QAU) performs periodic operational checks to ensure 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:
- Registration Approvals including documents preparation for registration
- Safety monitoring
- Reporting of safety information & the process of the study at particular time interval
- Monitoring Procedures
- Negotiate and prepare contracts and budgets
- Preparation of study reports
- Protocol Planning & Development
- Presentation of Protocol at IEC Meeting
- Designing of Case Record Forms (CRFs), Informed Consent Forms (ICFs), CIB ,Patient diary & Investigator Manuals
- Site selection & feasibility
- Investigators’ & Staff Training on Prtocol & GCP Guidelines
- Source Data Verification at sites by detailed monitoring plan and execution
- Safety Management including Adverse events / Serious adverse events
- Handling QA Audit Visits
- Management as per trial specific process management manual
A R L holds the high quality standards with the advantages of a mid size organization i.e. low cost high speed working culture, fast decision making process and optimal organizational structure with a mount confidence level regarding our quality results. ARL has its own Clinical Pharmacology Unit, analytical lab, quality assurance and data management teams and Biostatisticians. The clinical research centre conduct bioequivalence/bioavailability studies under strict ICH-GCP Schedule Y guidelines and the studies are monitored by an independent ethics committee.