The rationale of clinical trial/BA-BE monitoring is to guarantee that the trial data is meticulous, complete and authentic, and in compliance with ethical and scientific standards. The attributes of monitoring of BA-BE/clinical trial are the base of adequate execution and the success of each clinical trial depend upon it. Perfect monitoring is crucial for a clinical trial, both to protect the integrity of scientific data and to yield valid Regulatory data. To ensure that this data adheres to protocols and international guidelines, the need of the hour for organizations is to opt for an expert medical writing partner who is well-versed with audit and monitoring.

C-Trials Global Clinical has excellent experience and expertise in risk-based clinical trial monitoring that ensures scientific excellence and data integrity.

C-Trials Global Clinical engages a divergent range of specialized skilled staff to perform all aspects Monitoring and Site Management. C-Trials Global Clinical has the extent to facilitate clinical services throughout in most corners of the globe.

Our operational personnel are based globally. We aim to minimize travel, boost support for project teams and importantly advantage local knowledge of the clinical research and regulatory environments.

C-Trials Global Clinical offers an experienced team of regionally based monitors, all with top in class monitoring experience in all therapeutic areas that includes oncology, gynecology, Dermatology, respiratory, orthopedic etc. Our global clinical research associates (CRAs) focus on developing strong site relationships while ensuring adherence to data quality, subject safety, and early issue resolution throughout the course of the trial. Comprehensive monitoring plans are crafted to address trial complexity and sponsor requirements, and often combine traditional monitoring visits with robust site management and remote monitoring tactics.

C-Trials Global has experience of Monitoring more than 1000 BA/BE studies and including PKPD and PD trials/Post Marketing Surveillance

We offer independent Clinical Trial/BABE monitoring visits – such as

  • Site Initiation Visits
  • During study interim monitoring visits (Check in, dosing, vitals and post dose activities)
  • Site Close Out Visits (once CSR is ready for review)

We offer independent Bio-analytical monitoring visits – such as

  • In process Bio-analytical Monitoring
  • Retrospective Bio-analytical Monitoring

Our Monitoring process includes

  • Quality source data verification
  • Quality review of monitoring reports
  • CRO/Site feasibility
  • Expertise regulatory submissions
  • ICH GCP compliance
  • Monitoring plans (Based on Risk-Based Monitoring Approach)
  • Sponsor comment/Query resolution
  • On Site training and Management
  • IMP accountability
  • Site management support and documentation
  • Medical monitoring

We’re in the best ground for clinical monitoring – precisely. Our teams all have local knowledge and language familiarity so they understand the distinction involved in each market; from regulatory differences to cultural differences. We initiate projects expeditiously, with teams prepared and accessible to advance the process complete.

Flexile Monitoring approach

We are constantly adapting and finding new, innovative ways to deliver. Always one step ahead, we’re all set for the ICH-GCP E6 and fully prepared for guideline changes anticipated recently.

Our flexible monitoring platform handles risk-based monitoring, targeted monitoring and centralized monitoring

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CT/BA/BE/PKPD Studies Monitored

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GCP Audits Conducted

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GMP Audits Conducted

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Training & Consulting Programs
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