OCTOBER 202319to 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 ExcellenceCliniexperts 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 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.'"
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