Searching for "clinical" found 137

India Clinical trials will be a pivotal part of India’s attempts to scale the global pharmaceutical value chain. Following a series of well-publicised scandals in the early 2010s, the country tightened up its clinical research regulations and saw a significant drop in trial numbers. However, with a revised regulatory landscape, a…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval. This is not one of the prerequisite conditions for approval of the clinical trial protocol, which…

France France is the third most significant clinical research destination in Europe, participating in 50 percent of the trials initiated across the continent. While favourable government policies and unique strengths such as the National Health Data System contribute to France’s competitiveness, obstacles to further growth remain. In conversation with PharmaBoardroom, Hubert…

India Under the leadership of Ajay Tandon and the foundational work of Dr Kiran Marthak, Indian firm Veeda Clinical Research has strategically expanded its capabilities and global footprint. The company has transitioned from focusing primarily on clinical research to incorporating preclinical services through the acquisition of Bioneeds, aiming to offer end-to-end…

Portugal While not a major player in clinical trials at the European level, Portugal has untapped potential in this field, leveraging a first pioneering centre in Braga, the country’s strong scientific community, a growing openness to collaboration with industry, and access to a European patient database. Considering the remarkable progress that…

Portugal Dr João Filipe Raposo outlines the importance of a collaborative, multidisciplinary approach to diabetes care management, an approach embodied by the APDP – Diabetes Portugal. He also touches on the APDP’s unique patient-centric model and the digital future of diabetes care.   I am optimistic that diabetes care will improve.…

Spain Having forged a solid position in clinical research in 2020 and 2021 when it became the fourth nation in the world and the first in Europe for studies conducted around COVID-19, Spain has continued consolidating its status as a leading clinical trials hub and registered over 900 trials in 2022,…

Portugal APDP is the association for people living with diabetes in Portugal, and the oldest such institution in the world. Deputy Clinical Director Dr Carolina Neves emphasises the APDP’s patient-centred approach to integrated diabetes care, its role in advocating for greater accessibility to treatments, why obesity treatment should be built into…

Japan Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised.   Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems…

UK A roundup of the biggest stories from UK pharma, including the latest agreement between the British government and industry on a renewed drug pricing clawback scheme; GSK’s search for deals in China; the London-based CRO hVIVO’s new USD 21 million contract, and the latest biotech arising from Cambridge startup incubator…

USA The US Food and Drug Administration has increasingly recognized the importance of diversity and representation in clinical trials over the past few decades. This evolution reflects growing awareness across medicine that differences in age, gender, race, and ethnicity can impact disease risk, treatment response, and health outcomes. Darshan Kulkarni of…

Global AI is the buzzword du jour across all industries, but what is needed for it to truly make a difference in clinical trials? Writing in December 2023’s DIA Global Forum magazine, Lokavant’s Rohit Nambisan lays out the three essential characteristics for AI impact in clinical research, foregrounding the vital importance…