The clinical research industry in India has emerged as a dynamic and rapidly evolving landscape, propelled by advancements in healthcare technology and increasing demand for innovative healthcare services. The country's diverse patient pool, cost-effective infrastructure, regulated market (CDSCO), and skilled workforce have made it a preferred destination for clinical trials. Despite its potential, challenges such as regulatory complexities and data privacy concerns persist. With the adoption of cutting-edge technologies and regulatory reforms, India is poised to witness further growth in clinical research, contributing significantly to global healthcare advancement.
Offering Best Clinical Trials & Regulatory Services
In the rapidly evolving healthcare landscape, where regulatory and research life cycles are shrinking, efficient and cost-effective services are paramount while maintaining uncompromised quality and safety. Enter Cliniexperts Research, a dynamic group of experts who have been at the forefront of regulatory consultancy services since 2009. With a steadfast commitment to excellence and a dual-pronged approach through their companies, Cliniexperts Research Services and Cliniexperts Research, they've been shaping the industry landscape for over a decade.
As India’s leading brand providing clinical research as well as regulatory services and trials across the disease spectrum, Cliniexperts Research is uniquely positioned to offer the best of both these worlds. These services are well aligned with ICH-GCP E6 Guidelines, NDCT Rule 2019, and MDR 2017. Here, Dr. Ashwini Kumar, CEO, explains the company’s binary business model and how it creates win-win situations for domestic healthcare players and aspiring India entrants.
Riding the Reforms Wave
On the opportunities triggered by India’s aggressive healthcare reforms, CEO, Dr. Ashwini Kumar says, “We are excited to be part of this (opportunities). I am particularly bullish on the medical devices sector, to achieve global standards of quality within a reform-oriented environment."
Gamut of Services
With an extensive and diverse range of services, Cliniexperts Research stands out as a leading Clinical Research Organization (CRO) in India. Having a vast database of Key Opinion Leaders (KOLs), the firm possesses an unparalleled network of subject matter experts with capabilities extending to seamless coordination with research sites, ensuring smooth operations throughout every phase. With full-scale workforces deployed in Delhi and Bengaluru, Cliniexperts Research has a firm footing in the northern and southern regions and is expanding rapidly to have a pan-India footprint.
Its unique amalgamation of research support and regulatory guidance provides clients with comprehensive 360-degree solutions. As a testament to the commitment to quality and security, the team holds certifications including ISO 9001:2015 and ISO 27001:2013.
At the heart of Cliniexperts Research's service spectrum are flagship offerings such as Study Design, Project Management, Site Management, Vendor Management, and Data Management. With a focus on tailored solutions, the firm provides bespoke and highly effective clinical trial services.
The firm's exceptional capabilities encompass every aspect of the clinical research journey, ensuring optimal outcomes for valued clients. On this business, Dr. Kumar explains, “This has been our mainstay since 2009. Having partnered with 700+ domestic and global companies to fulfill their regulatory and Research mandates, we have achieved standalone capabilities in this business. We recognize the uniqueness of each clinical trial, which is why we provide customized solutions led by seasoned and informed Key Opinion Leaders. Our collaboration with clients commences with a comprehensive assessment of their needs, leading to a tailored strategy that steers the clinical trial journey.
Our dedicated team formulates studies that fully comply with relevant regulations and executes trials at meticulously chosen locations to maximize results."Behind Cliniexperts' success lies a team of experienced professionals, each contributing their wealth of experience to every project undertaken. The dedicated team includes proficient project managers, skilled Clinical Research Associates (CRAs), and capable Clinical Trial Assistants (CTAs). Their collective expertise ensures the seamless execution of projects, delivering exceptional results. What sets Cliniexperts Research apart as a truly unique service provider is the firm’s 13+ years of experience in providing regulatory support. This extensive background in regulatory affairs distinguishes the company in the market, allowing the capability to navigate the complex landscape of clinical studies with unparalleled insight.
Approach to Excellence
Cliniexperts Research's approach is built upon a foundation of scientific excellence and technical expertise, guided by uncompromising ethics. The firm engages in real-world evidence studies involving robust clinical trial data and scientific information in a transparent and ethical manner, ensuring that the patient's condition is fully understood and their treatments are meticulously captured. Through this approach, data collection is accelerated while maintaining the highest standards of quality and integrity. The firm’s focus extends to regulatory compliance and label expansion, allowing the team to provide additional indications for the products.
The cliniexperts research motto of 'safety, ethics, and absolute data integrity' is the secret behind us
“The pandemic has taught us not to be complacent about newer diseases and viruses. The Nippah and Zika viruses, Lassa fever, SARC, Ebola, Marburg; I could keep going. It’s going to be a busy century for everyone in the drug and vaccine discovery loop. Cliniexperts' agenda to contribute to the fight against future outbreaks is creating robust, agile, and effective disease-fighting protocols is the only option we have in our fight against newer outbreaks. Recognizing the need to act on this, we established Cliniexperts Research Services eight years ago. This activity has grown steadily, and today, it is a critical business that empowers us to offer world-class clinical research and drug trials to sponsors, spanning all trial phases, PMS studies, and all other trial design elements,” Dr. Kumar says.
Explaining the trial design process, Dr. Kumar says, “The experts present the completed RFP and initiate a kick-off meeting, introducing the project team to the sponsor. As the protocol and study materials are prepared, the focus shifts to site feasibility, vendor finalization, and regulatory compliance, including attending SEC meetings and obtaining necessary approvals. The engagement extends to ethics committee approval and investigator meetings, both in-person and virtual. Further planning involves creating study-related documents, and risk management plans, and aligning them with the client's objectives. Thus, the outcomes of our trial designs are on par with global benchmarks.”
Future Roadmap
In just seven years, Cliniexperts Research Services has made impressive strides in the industry, forging a strong clientele of renowned names such as Galderma, Win Medicare, Healthium, Glenmark, Modimundi, and more. The firm’s footprint spans across India, showcasing expertise in Pharmaceuticals, Medical Devices, IVDs, cosmetics, and food products. This diverse portfolio positions the company as a reliable and versatile CRO partner. To enhance its accessibility and engagement with sites and stakeholders, the firm expanded its reach to Bengaluru, further strengthening its connection with the industry.
“The Cliniexperts Research motto of 'safety, ethics, and absolute data integrity' is the secret behind staying on top of the latest tools and technologies to ensure the most efficient and effective Clinical trials. The journey towards excellence continues unhindered, and our promise of safety at any cost, excellence at any price grows stronger with each passing year”, Dr. Kumar sums up. For the coming years, Cliniexperts Research's focus is on establishing a comprehensive dicentric patient pool across various therapeutic domains, enhancing the ability to contribute to diverse research endeavors.
Additionally, the firm is actively engaged in expanding its offerings to include robust pharmaco-vigilance services. These strategic initiatives align with the commitment to driving advancements in medical research and emerge as the industry leader. While on this subject, Dr. Kumar emphasizes, “With a foot each firmly entrenched in the research, trials and regulatory affairs domains, Cliniexperts is India’s leading entity offering all these full-scale and full-spectrum services under one roof. I invite companies across the globe to come to India. To them, we assure project partnerships with the motto, 'safety, ethics, and absolute data integrity.'"
