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India has turned out to be a responsive market for clinical data management for clinical trials engagement. In the past, clinical data was often collected using paper-based systems, making it difficult to manage and analyze large amounts of data. This led to errors, delays, and increased costs.
According to Krutikesh Age, co-founder, DPHS, a clinical research, development, diagnostics and data management solutions company, with the advent of electronic data capture (EDC) systems, clinical data management became more efficient and reliable. EDC systems allowed for faster data collection, real-time data monitoring, and improved data quality.
The Indian market for clinical research, data management, and drug development solutions is rapidly growing and evolving. India has become a popular destination for clinical trials due to its large population, diverse patient pool, and lower costs compared to developed countries, he added.
Clinical data management is a critical component of clinical trials. The use of advanced technologies, such as machine learning and artificial intelligence, has made it possible to collect and analyse large amounts of data more efficiently. CDM also plays a critical role in ensuring regulatory compliance and patient safety.
As time goes on, the complexity of the trial data increases, producing enormous volumes of data. Since they may alter one or more design elements in response to subject data, a great deal of researchers currently favour adaptive clinical design over fixed clinical design. With adaptive research, such as basket, umbrella, and platform designs, oncology medicines and biologics may be produced more quickly. Utilizing a dynamic, adaptable database architecture, the Master Study Protocol is being used to conduct multi-arm, cohort, and decision-tree investigations, Age told Pharmabiz.
Today's trials use wearable technology or sensors, more precise and large amounts of data, risk-based quality control methods, decentralised study, and adaptable designs. Clinical trials are becoming more difficult due to the increased emphasis on the patient experience and value differentiation, he noted.
One of the biggest challenges facing the Indian market is the complex regulatory environment. The regulatory process for clinical trials in India is lengthy and unpredictable, which can lead to delays and increased costs. Additionally, there are concerns about the quality of data generated in some clinical trials conducted in India.
Further, the clinical research industry requires highly skilled professionals, but there is a shortage of trained personnel in India. The industry is working to address this challenge by investing in training programs and partnering with educational institutions to develop new talent.
Advances in areas such as artificial intelligence, machine learning, and big data analytics are transforming the industry and providing new opportunities for innovation. However, adopting new technologies can be challenging, particularly for smaller companies with limited resources. Another issue is data security and privacy, he stated.
Despite these challenges, the Indian market for clinical research, data management, and drug development solutions is expected to continue to grow. Efforts are on to by the industry to address these challenges and capitalize on new opportunities to drive innovation and improve patient outcomes.
The future of clinical data management is likely to be shaped by advancements in technology. Wearable devices, sensors, and mobile applications will make it possible to collect real-time data from patients in clinical trials. Blockchain may also play a role in CDM by providing a secure and transparent way to manage and share clinical data, said Age.
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