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Biography

Gunjan Jain is a Principal Solutions Consultant, South Asia at Oracle Health Sciences. She is currently covering the presales for South Asia market working closely with biotech, pharma and clinical research services companies in the region. With more than a 13 years long experience in life sciences IT, she has worked with leading companies and has played an instrumental role in adoption of R&D and Safety solutions for Pharmaceuticals, Biotech and CROs. With strong focus on Drug Safety and eClinical suite, her area of expertise extends to streamlining of business processes for Pharmaceutical and CROs and regulatory compliance. In her consulting role, she has worked with several established Global life sciences firms as well as entrepreneurial ventures assisting them with defining end to end processes in Clinical data management, regulatory compliance and spearheading the implementation of health sciences business solutions. She has also been a frequent speaker at various national and international Life Sciences conferences such as DIA, Global Cancer Genomics Consortium, Bio Korea, Taiwan Safety Seminar, Seoul Safety Event, ISCR, India Health Forum and various Oracle events in India and ASEAN.

Abstract

India is once again aspiring to assume leadership in clinical research by trying to adopt a more patient centric regulatory framework in clinical trial sector in the country. We are going to witness if and how a country succeeds in garnering the limelight as a research hub, renew its ability to seize growth opportunities, develop capabilities to meet every challenge with a strategy and every opportunity with a plan. To make this dream even more difficult to achieve, if not impossible, the complexity associated with drug development has increased dramatically. The drug development science, regulatory, and economic landscape is fraught with uncertainty and risk. Science has become more complex, so it is the demands on sponsors to safeguard the well-being of clinical trial participants and the need to maintain the highest levels of data integrity. Other factors include the skyrocketing quantities of clinical data that must be managed and the necessity to plan for long-term trial follow up. In this session, let’s make an attempt to decode a winning formula for sustained and superior industry performance. There is a gamut of affordable and advanced technologies to tackle the 3 main challenges that this industry is facing - cost, data quality and patient safety. Technology already plays a central role in the conduct of clinical trials but industry today needs a new eClinical footprint to improve project oversight, make smarter trial decisions and gain efficiencies across clinical operations, while supporting patient safety, data integrity and compliance

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