Ardent Clinical Research Services: Ethically Rowing the CRO Industry in Diverse Areas of Therapeutic Research

Chandu Devanpally,Founder & MD

Chandu Devanpally

Founder & MD

ince ages, where countries are facing enormous challenges to counter the growing impact of disease, specifically infectious disease, infertility, and cancer, the clinical research industry lends an upper hand to mitigate the same. But to keep-up with the disparate need of the rising populace for better medical care had never been easy. Hence, CROs seemed to be a fine balance, to lead the clinical trials and develop new medications in the industry. Now, according to Grand View Research Inc.’s recent study, the global healthcare contract research organization (CRO) market size is expected to reach $54.7 billion by 2025, growing at a CAGR of 6.6 percent each year. In such scenario, Pune-based Ardent Clinical Research Services is one of the leading providers amongst many contributing to the industry rendering an end-to-end integrated clinical trial services along with operational facilities to the pharmaceuticals, Biopharmaceuticals, Device companies, Herbal and Nutraceutical companies.

Outperforming through it’s quality & transparency of work, set timelines and cost-effectiveness, in this huge competitive world of clinical research, Ardent carves a niche amongst many prominent multinational CROs across the country. Its huge list of offerings range insights right from the site
selection & feasibility to Final Study Report submission. Starting-off with a proactive approach & close attention to ‘Client Requirement’, it relieves their concerns through Risk Assessment and Mitigation Plan, followed by a strong clinical monitoring at the clinical sites, assisting the sites with study related questions. Supported by a deep understanding and experience in dealing with the Indian drug control regulations, Ardent facilitates all stages (Phases I-IV, BE and device studies) of drug development. As the entire process generates critical clinical trials’ data, Ardent safeguards it through end-to-end (Data Management Plan to Database Lock) comprehensive CDM. Besides this, the AEs & SAEs are also in place, reported and processed accurately as per the regulatory guidelines. Utilizing its fully trained CRA members (in FDA regulations, ICH guidelines, and GCP/SOP compliance), Ardent exercises strong monitoring, bestowing its clients with most of their experience in key therapeutic and specialty areas.

Supported by a deep understanding of, and experience in dealing with the Indian drug control regulations, Ardent facilitates all stages (Phases I-IV, BE and device studies) of drug development

Overcoming several challenges in the field of clinical research, Ardent has imparted its indifferent services to numerous major and minor companies across the country. Some of the latest developments at the company are inhouse eCRF, IWRS system and MedDRA coding. Ardent is currently working on few phase-3 studies on ABSSSI, Age Related Macular Degeneration, Influenza, Diabetes and others. The company had also been nominated for Red Herring, 2017 Award in the Asia-Pacific region due to its indifferent deliverables. “In clinical research field, where an organization must follow all the regulatory guidelines such as ICH-GCP, US FDA, EMEA, New Drugs & Clinical Trial Rules - 2019, and 21 CFR, Ardent adheres to the all the required guidelines while conducting the clinical trials,” asserts Chandu Devanpally, Founder & MD, Ardent Clinical Research Services.

Further Sphere
Established in 2014, Ardent is quite satisfied with its growth, relishing a significant revenue YoY. Chandu proudly says, “Where our company’s revenue used to be in lakhs is now in crores. So have we grown in the last five years in this competitive
world”. Incessantly updating all its services inclined with the client feedbacks and user experiences, Ardent is determined to grow along.