Clinical Research Services

India being favourite destination of all leading pharmaceutical companies for outsourcing of Phase I‐IV clinical trials, our presence with customer tailored service gives us edge over others.

Quality focused approach of GCP guideline encourage to offer Monitoring and Auditing services for clinical research outsourcer.

Our unique approach of Project Specific Quality Management Plan enable our client to ensure and assure quality at every stage of clinical trial be it clinical, bioanalytical or data management phase.

Our highly skilled and experienced monitors and auditors with focused vision on quality let us our client serve better.

Remote monitoring of clinical trial sites as per US FDA issued guidance

WHY CELUI

  • Independent Monitoring and Auditing services under one umbrella
  • One of the few companies in India to offer stand alone remote monitoring service
  • Presence of Monitors across globe gives us GCP as well as local regulation compliance and language benefit
  • Flexible and Cost effective business model
  • Standalone activities eg. Independent Monitoring, Independent Auditing, Site focussed quality control monitoring for high risk sites
  • All activities are driven by SOP which is mandatory part of our Robust Quality Management Proven track record of quality and compliance
  • Dedicated Project Manager for all projects

Site Monitoring and Quality Control Visits

BA/BE studies

  • Independent On site monitoring of Clinical and Bioanalytical phase
  • Retrospective Data review/ Quality Control

Clinical Trial Studies

  • Study Investigator Identification
  • Site Qualification Visits
  • Site Initiation
  • Training to the site employees
  • Interim Monitoring Report
  • Review and Collection of Documents
  • Close‐Out Visits

Quality focused visit for high risk sites

Remote Monitoring

  • We are amongst the very few company in India who offers stand alone services on risk based remote monitoring.
  • Our thorough understanding in key elements of monitoring and effective use of technology enable us to design Key Risk Parameter. Effectiveness of our remote monitoring can be measure by our Trend analysis method.

Audits

  • Vendor Qualification Audits
  • Clinical and Bioanalytical Lab Audits
  • Computer System Validation Audits
  • Clinical Trial Site Audits
  • Trial Master File Audits
  • Mock Inspection Audits

Medical Writing

  • Clinical Trial Protocol Development (Phase I‐ Phase IV)
  • Investigator’s Brochure
  • Informed Consent Forms
  • Case Record/Report Forms (CRFs)
  • Narrative Writing
  • Clinical Study Report (CSR)

Translation

  • To make single window for client with regulatory affairs and Pharmacovigilance services, added in our portfolio
  • Team of experienced translators
  • In-house multi-lingual translation services
  • Translation for major Languages (Foreign & Indian)

In-House process for Translation