Auriga Research

Leading Indian CRO

  • Home
    • About Us
    • Arbro Group
  • Testing Services
    • Pharmaceutical Testing
    • Food Testing
    • Herbal Testing
    • Cosmetics Testing
    • Medical Device Testing
    • Water Testing
    • Sensory Analysis
    • Inspection & Sampling
    • Construction & Building Material Testing Lab
    • Shelf Life Studies
    • Analytical Research
      • Characterization
      • Method Development
      • Method Validation
      • Stability studies
      • Impurity Profiling
      • Routine Analysis
  • Clinical Trials
    • Clinical Trial Regulation in India: Recent Updates
    • Feasibility Studies
    • Cosmetic Clinical Trial
    • Medical Writing
    • Investigator Selection
    • Project Management
    • Site Management
    • Monitoring
    • Clinical Trial Formulation
      • Clinical Trial Services (Phase I to IV)
    • Laboratory Services
      • Accomplishments
  • Bioequivalence Studies
    • Bioavailability & Bioequivalences Studies
    • Bioanalytical Methods
    • Clinical Facilities
    • Project Management
    • Medical Writing
    • Regulatory Assistance
    • Biowaiver Monograph
    • RLD Sourcing
    • Volunteers with us
  • Certification Divison
    • Overview
    • Services
      • QCI Scheme for India HACCP and India GHP
      • FSMS/ISO 22000:2018
    • Quality Policy
    • Complaint Redressal
      • Procedures – IndiaGHP & IndiaHACCP
      • FSMS/ISO 22000:2018
  • COVID 19 Testing
  • Free E-courses
    • Ethics Committee Accreditation and Registration in India
    • Analytical Training
    • Free E-Course on Bio-Equivalence Studies
    • New Drug Approval in India: A free online course
    • Free e-Course : Regulation on Medical Devices and Diagnostic Kits in India
  • Contact Us
    • Current Openings
    • Business Queries
    • Investigator Registration
    • Partnering With Us
  • News
    • Workshops
    • Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices
You are here: Home / Clinical Trial

Clinical Trial

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.

Share this:

  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to share on Twitter (Opens in new window)
  • Click to share on Reddit (Opens in new window)
  • Click to email this to a friend (Opens in new window)
  • Click to print (Opens in new window)

Quick Query

News

  • Commencement of new Analytical laboratory
  • Oryzanol Testing in Mustard Oil Using HPLC Method- Enforcement by FSSAI
  • CIIE, Shanghai, China (5th-10th November 2019) Booth No M5, at Hall 7.1 H
  • Ethics Committee Accreditation and Registration in India: Introduction
  • DTAB recommends not using vegetarian indicator on cellulose capsules and prohibits use of PET bottles for packaging pharmaceutical drugs
  • A report by AIIH&PH on the use of PET or plastic bottles for packaging of pharmaceutical preparations, soft drinks and alcohol
  • Arbro Pharma & Auriga Research Exhibiting in ASIA LABEX 2015
  • Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices
  • Great News! Auriga BE Center is now approved by NPCB, Malaysia
  • Conference on Accreditation of Sites, Investigators and Ethics Committees

Tag Cloud

Analytical testing lab Approved Drugs Clinical Research Compensation Dcgi Drug Approved Drug List Fdcs Fixed Dose Combination Informed Consent Process Mustard oil testing Not Approved Pharmaceutical testing Webinar

Socialize with us!

  • Facebook
  • Google+
  • LinkedIn
  • Twitter

Signup for our mailing list!






Contact Us!

Auriga Research Pvt. Ltd. (A Contract Research Organization)
3/15 Kirti Nagar Industrial Area
New Delhi
India 110015
e-mail - [email protected]
Telephone - +91 11 45754546

Copyright © 2021 Auriga Research Pvt. Ltd.

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.