Drug discovery and development is a vigorous process that hops with the recent advances in pharmaceutical field, which requires understanding of pharmacokinetic, pharmacodynamics, pharmacogenomic profile of the drug. Development of new drugs is of prodigious importance for many clinical conditions but rising cost of drug development leads to decrease in number of drugs getting marketing approval. Additionally, drug development is a long, complex and expensive procedure. New technologies are disrupting all industries, including health care and drug development. Technological novelties increase efficiency and productivity using inventive outcomes, increased patient engagement, reduced patient burden, and improved trial management.

An estimated 85% of all clinical trials will experience delays; with 94%, being delayed by over a month. The financial impact can be massive, costing between $600,000 - $8 million every day. Moreover, the direct impact on clinical trial budgets, delays can also affect the long-standing profitability of a drug by plummeting its patent period. Evaluations vary, and are questioned, but whether measured in pounds, euro or dollars, the amount of money lost in clinical trials delays is in the billions, and increasing annually.

India is one of the desired locations for outsourcing clinical research services due to availability of human subjects for enrolment, skilled clinical research professionals, cost effective and comprehensive databases and software for data management. The specialized organizations known as the CROs (Clinical/Contract Research Organizations) play a pivotal role in rise of clinical research industry in India. Growth of IT industry in India lend a hand for the evolution of clinical research industry and to generate effective and high quality clinical research data, and maintain a balance between the expectations and restraints in the existing systems. In a country like India that is driven by technological developments and business demands, this all is possible

Indian Pharmaceutical companies can streamline clinical research processes by joining hands with IT Industry. They should focus on process reengineering and IT validation, and make the IT landscape slenderer, smoother, accessible and future-ready. Implementation of enterprise data lakes and big data analytics, and investing in building capabilities in advanced analytics, and be focused to improve data quality and accuracy by implementing standard methodologies and next-generation technologies. Pharmaceutical industries can pool resources with technology vendors, CROs, for better trial outcomes. They should adopt a progressive and risk management strategies, and redefine and formalize data management policies, procedures and SOPs etc. Nurtured new skillsets such as big data, artificial intelligence, machine learning, cloud infrastructure management etc. They should also build fulproof data governance structures to ensure privacy, security and ethical handling of clinical data including genomics data, Health economics and outcomes research (HEOR) data. Thereby reducing cost and time in clinical trials study to process new interventions.

Furthermore, A new method of micro dosing has been evolved using big physics instrumentation to obtain human pharmacokinetic information before the usual expensive phase I safety program is accompanied is the phase 0 micro dosing. It is anticipated that micro dosing will help to lessen or substitute the extensive animal testing of compounds for kinetics, which may later be rejected in human studies. Therefore, micro dose studies use small quantities of drug, which is not envisioned to produce any pharmacologic effect, when administered to humans, and, hence, may not cause any adverse events also, but may produce useful pharmacokinetic information and help in development of the new compound. The implantation of this technique may reduce both and cost of clinical trial study.

The clinical research industry should accelerate digital transformation of systems and tools to better process large volumes of data captured from multiple sources. Innovation in technology and advanced predictive analytics across the clinical data will effectively reduce the time taken in the process of data capturing to reporting, fast-track the regulatory submissions and approval process, and ultimately lessen the time and cost of bringing new drugs and devices to the market.