Conference on Clinical Data Management 2010

Venue: ITC Maratha

Location: Mumbai, Maharashtra, India

Event Date/Time: Oct 19, 2010 End Date/Time: Oct 19, 2010
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The pharmaceutical business is under huge pressure and needs to be more competitive if it is going to stay successful. Every day companies generate large amounts of data, much of which is never fully leveraged. Traditional approaches to data collection and management prevent the full curation of all data within a company, leading to a substantial opportunity lost for that company. Why is this? Do companies really understand the full power of the data they own? What can be done by your members of your organisation to advance the thinking and technology?

India has developed into a super power for IT skills and has become a major hub for pharmaceutical and biotech manufacturing and contract research, the outsourcing business in various other segments is also exhibiting promise. Clinical trial data management and statistical analysis is one such area which is growing rapidly, accompanied by a variety of players entering into different models of this business. This conference will reflect on the data management business in India and review the emerging outsourcing models in this growing pharma industry.

Few tasks in R&D rival the complexity of clinical data management while its importance in providing clean and correctly mapped data carries direct impact on the success of drug submission. In times of increasing trial costs and the rising threat of clinical outsourcing, keeping ahead of competition and abreast of the latest developments is paramount to surviving a harsh CDM climate. The role of data managers has experienced a fundamental shift from doer to controller, from data collector to system administrator. This year’s conference will capture the essence of electronic data integration, interface interoperability and system optimisation to spearhead a global understanding of data standardisation and usher clinical data management into a time- and cost-efficient second generation. Meticulous care has been taken to offer practical solutions and real-life case studies to combat the challenges of CDM. Market leaders will share their ideas and outline their action plan to crucially assist your decision-making process when improving Data capture and integration, Outsourcing strategies, Data cleaning, validation and mapping, CDISC implementation and compliance, Vendor and project management skills

CDM 2010 will provide you with the data that you need to recognize this complex and rapidly-expanding sector. Knowing the future market, and what impact will that have on future business opportunities? This is your opportunity to stay ahead by learning the latest trends and networking with the trend setters.

It gives us immense pleasure in welcoming you to the Clinical Data Management ’2010.

Key Speakers

* Dinesh Pillaipakkamnatt, Global Head - DB Programming, IIS TS, Novartis
* Celestine Juliet, Project Manager, Regulatory Affairs, Clinical Research, Cipla
* Chirag Trivedi, Head - Medical Affaris Clinical Operations, Sanofi Aventis
* Poonam Sule, Senior Clinical Study Manager, Pfizer
* Anil Arekar, Senior Consultant – Biostatistics - Asia Pacific, Johnson & Johnson
* Deepti Sanghavi, Medical Advisor- Clinical Research, Wockhardt
* Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates
* Zinobia Madan, Founder & Managing Director, ClinOma Healthcare
* Milind Sardesai, Medical & Regulatory Affairs, Clinical Research Physician, Chiltern
* Jino Joseph, Senior SAS Programmer, GlaxoSmithKline


* Current trends of clinical data management & how can you take advantage of the current global market
* Driving for success is highly vital, but are you driving as smart as with strategies and tips on the most efficient ways to register clinical trials and results while best utilizing available resources
* Data management, CMC SCM, operational requirements & CRO infrastructure in India & South Asia
* Discovering cutting edge EDC technology and assess the latest database and data capture systems available
* Leverage the importance of CDISC compliance and standardized data capture to achieve effortless submission
* Overview of the various types of data that data managers working in oncology handle and the associated challenges
* How to land up in finding the right BPO partner
* Achieving consistent application & implementation of data standards to speed trial process
* Identifying the key critical factors for developing knowledge and skills in vendor management
* Attain solid vendor management skills to expertly juggle outsourced tasks
* Discovering technologies and strategies for successful clinical data management
* Avoiding potential pitfalls of data management
* Working with limited budget to ensure on time study completion
* Be prepared for audits; site, CRO and in-process trial audits

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ITC Maratha