Why Include India in Global Clinical Trials? Key Advantages for Pharma and Biotech
Introduction Global clinical trials (GCT) have become the backbone of modern drug development. With regulators demanding diverse patient populations and real-world data, sponsors are increasingly turning to geographies beyond North America and Europe. India, with its unique advantages, has emerged as a strategic hub for global clinical research. From a large treatment-naïve population and a […]
Regulatory Framework in India for Clinical Trials: Important Regulations and Compliance Overview
Introduction The regulatory framework in India has evolved rapidly over the past decade, becoming more structured, transparent, and aligned with global standards. Dr. Deepa Arora, Founder, Director, and CEO of CLINEXEL explains, “Indian regulatory structure is akin to that of the USA. Like the USFDA, CDSCO is the single CLA in India responsible for clinical […]
Conducting Clinical Trials in India: The Pharma Industries Next Big Advantage
Introduction India is emerging as a strategic hub for high-quality, diverse, and globally relevant clinical trials. With a population exceeding 1.4 billion and a disease spectrum that mirrors global health challenges, the country offers unparalleled opportunities for pharmaceutical companies looking to advance drug development efficiently and effectively. Poor recruitment rate in clinical trials is a […]
Selective Safety Data Collection in Clinical Trials: Aligning with ICH E19 Guidelines
Introduction As the pharmaceutical industry embraces smarter, leaner, and more patient-centric approaches to clinical development, Selective Safety Data Collection (SSDC) has emerged as a pivotal strategy for improving the efficiency of late-stage and post-approval trials. In particular, the harmonization led by the International Council for Harmonisation (ICH) through the E19 guideline, in alignment with foundational […]
Medical Monitor in Clinical Trials: Essential Roles & Best Practices
An Expert Perspective on Medical Monitor in Clinical Trials In the realm of clinical development, patient safety and efficiency are of utmost importance. A medical monitor in clinical trials plays a pivotal role across the clinical trial, starting from designing the study until clinical study report. Ongoing review of data by medical monitors in clinical […]
Clinical Trials in Oncology: Planning and Conducting Multi-Regional Clinical Trials
In September 2024, the U.S. Food and Drug Administration (FDA) introduced a pivotal guidance document titled “Considerations for Generating Clinical Evidence from (MRCTs) Multi-Regional Clinical Trials in Oncology.” This guidance serves as a comprehensive roadmap for optimizing drug dosages in oncology trials and outlines strategies for effectively planning, designing, and executing MRCTs in cancer research. […]
US FDA Guidance on Dose Optimization for Oncology Drugs -Clinical Pharmacokinetic considerations
The FDA guidance on dose optimization for oncology drugs has introduced a pivotal framework aimed at refining dose selection in cancer treatments. This guidance emphasizes the importance of clinical pharmacokinetics (PK), population PK analysis, and dose-response relationships to ensure the efficacy and safety of oncology drugs. Importance of Clinical Pharmacokinetics in Dose Selection Clinical pharmacokinetics […]
Clinexel Appoints Dr. Mukesh Kumar as Chief Scientific Officer
In a significant move to reinforce its leadership team, Clinexel, a full-service Clinical Research Organization (CRO), has appointed Dr. Mukesh Kumar as its Chief Scientific Officer (CSO). With extensive experience leading Clinical Research & Development (RnD) in global pharmaceutical giants such as Sanofi and Daiichi Sankyo, as well as Indian pharmaceutical leaders like Cipla, Dr. […]