Welcome to Ardent Clinical Research Services (ACRS)

Your Trusted Partner in Clinical Operations. At Ardent Clinical Research Services (ACRS), our Clinical Operations Department is dedicated to helping you design, initiate, manage, and successfully complete your clinical trials—from first patient in to final submission and regulatory approval. With an expert team, robust infrastructure, and a proven track record, we deliver end-to-end clinical operations services that drive speed, compliance, and scientific excellence across every phase of research.


What We Offer

Our comprehensive and reliable Clinical Operations services are tailored to meet the specific needs of each project, ensuring smooth execution and optimal outcomes.

We provide every sponsor with a dedicated project partner—your single point of contact—who guides you through all stages of the trial and facilitates seamless access to ACRS’s full service capabilities.


Our Clinical Operations Services Include:

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Clinical Monitoring

  • On-site and remote monitoring by GCP-trained CRAs
  • Site initiation, interim, and close-out visits
  • Source data verification and risk-based monitoring

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Clinical Study & Project Management

  • Comprehensive project oversight from start-up to close-out
  • Milestone tracking, timeline management, and budget control
  • Real-time communication and issue resolution

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Regulatory Operations & Approvals

  • Clinical trial application (CTA) submissions to CDSCO and global agencies
  • Ethics committee submissions and correspondence
  • Regulatory strategy and risk assessment

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Medical Writing

  • Protocols, Investigator Brochures, ICFs, and CSRs
  • Safety narratives and regulatory documents (CTD modules)
  • Scientific manuscripts and publications

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Clinical Data Management

  • Database design, data entry, validation, and cleaning
  • Query resolution, coding (MedDRA/WHO-DD), and database lock
  • CDISC-compliant outputs for regulatory submissions

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Biostatistics & Statistical Analysis

  • Study design consultation, sample size calculation
  • Statistical analysis plan (SAP) development
  • Interim and final analysis with CSR integration

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Medical Monitoring

  • Ongoing medical oversight during the trial
  • SAE review, protocol deviation assessment, and safety signal evaluation
  • Investigator support and clinical consultations

Why Choose ACRS Clinical Operations?

Deep therapeutic area expertise across multiple indications

CDSCO-registered CRO with ISO 9001:2015 QMS certification

Experienced team of project managers, CRAs, regulatory experts, and medical writers

Fast, flexible, and sponsor-centric approach

Full-service capabilities under one roof


Your Partner in Clinical Research Excellence

At ACRS, we understand the unique complexities of clinical research. Our Clinical Operations team is committed to delivering services with precision, speed, and integrity. We aim not just to manage your trials, but to accelerate your development programs, reduce risks, and support successful regulatory outcomes.

Partner with Ardent Clinical Research Services for streamlined, compliant, and results-driven clinical trials.