Ardent Clinical Research Services – Year-wise Achievements (2014–2025)

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2025

Global Recognition

Global Recognition and Landmark IND Approvals

  • Awarded Most Innovative Clinical Trial Solutions Provider 2025.
  • IND approval for Nor-UDCA from DCGI (landmark achievement).
  • Key late-phase global studies:
  • • Semaglutide injection (T2DM)
  • • Ondansetron ER injection (CINV & RINV) – Phase III
  • • NUVASTATIC (4 oncology trials)
  • • Silodosin + Solifenacin (BPH, Phase III)
  • • Capecitabine (EMEA submission)
  • Expanding global collaborations in Hungary, Vietnam, Malaysia, Philippines, Dubai and Sri Lanka.
coronavirus

2024

Pandemic Response

Innovation and Advanced Clinical Research

  • Recognized as Most Innovative Company of the Year 2024.
  • Studies on Needle-free injection systems for vaccines (HPV, MMR, Hexavalent, Paediatric PMS vaccines).
  • Completion of Nor-UDCA trial in NAFLD.
  • Studies in oncology (NUVASTATIC in TNBC and colorectal cancer), BPH (Pro-Plus), Type 2 Diabetes, stress, and oligospermia.
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2023

Expansion Phase

Oncology and Global Submissions

  • Capecitabine (500mg) trials for breast and colon cancer (MHRA submission).
  • FCM (Ferric Carboxy Maltose) trial with 196 patients for EMEA submission.
  • Fixed Dose Combination (Dapagliflozin + Gliclazide) – product approval in Nov 2023.
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2022

Regulatory Excellence

Regulatory Milestones and Key Trials

  • DCGI approval for Fixed Dose Combination (Vildagliptin + Pioglitazone) for Type 2 Diabetes.
  • Key trials in hypertension (Telmisartan vs. Cilnidipine) and NAFLD (polyherbal formulations).
coronavirus

2021

Pandemic Response

Major COVID-19 Trials

  • Conducted Molnupiravir study in 1218 patients.
  • Awarded two COVID-19 Phase II trials by CSIR-IIIM & AYUSH Ministry.
  • Multiple herbal/nutraceutical studies for COVID-19, obesity, metabolic syndrome, CKD, and BPH.
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2020

Expansion Phase

Pandemic Response and Technology Development

  • Rapid adaptation to COVID-19 research requirements.
  • Initiated COVID-19 related antiviral and herbal/nutraceutical clinical trials.
  • Development of in-house SOURCE TRANSCRIPT software for eCRF and IWRS.
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2019

Regulatory Excellence

Compliance and Quality Certification

  • Compliance with New Drugs & Clinical Trials Rules 2019 (India).
  • Achieved ISO 9001:2015 certification for Quality Management System.
coronavirus

2017 – 2018

Pandemic Response

Strengthening Operations

  • Expansion of operations with a dedicated office in Hyderabad.
  • Strengthened team with experts across clinical, regulatory, and QA functions.
  • Recognition as an emerging CRO for quality and cost-effective clinical trial solutions.
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2015 – 2016

Expansion Phase

Early Expansion of Services

  • Initial expansion of services in medical writing, data management, monitoring, and regulatory support.
  • First BA/BE and early phase studies initiated.
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2014

Regulatory Excellence

Foundation

  • Foundation of ACRS by Mr. Chandu Devanpally in Pune as a one-man venture.