Global Data Management & Medical Writing: The Asia-Pac Advantage

The complimentary live webinar is offered on two different dates/times for your
convenience (duration: 60 minutes plus Q&A session)

Wednesday, Sept 26 @ 11:00am EDT (N. America)
Hover here for timezones

Thursday, Sept 27 @ 1:00pm IST (India)
Hover here for timezones

Global Data Management & Medical Writing: The Asia-Pac Advantage

The key component to a successful trial is good Data Management practices along with statistical analysis and medical writing.

Asia –Pac has become a strategic clinical data management / medical writing base in which to achieve savings in cost and time investment; globally. Why? Because global clinical research standards are followed to ensure compliance with: CDISC, HIPPA, ICH-GCP and FDA practices. India in particular has a ready talent pool of IT/Medical professionals with lifesciences backgrounds which propels the country’s advantage and competitiveness in this space.

Complimentary pressentation will focus on the following areas:

• Clinical Data Management & Medical Writing: a global and Asia-Pac perspective
• Capabilities for EDC and/or paper CRF as well as robust, online applications for IWRS
• Faster Turnaround times without sacrificing quality
• Legacy Data Conversion – how to utilize huge amounts of patient data from previous years
• FDA submissions regarding CDISC Standards [one stop solution for global regulatory submissions] - SDTM and ADaM implementations
• Medical Writing deliverables, process flow, project timelines and training
• Summary of why global sponsors and regulatory bodies accept and approve of Asia-Pac data management & medical writing services

Executives involved in clinical trial research for small, mid-size or large pharma, biotech, and device companies looking for quality data management and medical writing results that are timely and cost-effective. Attendees to include [but not limited to]: Outsourcing Managers, Clinical Research Directors, Chief Medical Officers and IT/Information Officers.

Mr. ‘Kotesh’ Govind has been an integral part of Max Neeman’s Data Management Center since operations began. He has over 5 years of work experience as a team leader, statistician/senior SAS Programmer and Junior Statistical Analyst/SAS Programmer in Sristek consulting PVT.LTD., Hyderabad, India. He has also worked with SAS Global Services in PUNE as a consultant for Sristek.

Mr. Govind is a certified SAS Base Programmer from SAS Institute Inc. and holds a Master’s Degree in Statistics from “Osmania University College of Science; a Bachelor’s Degree in Mathematics, Statistics and Computer Science from “Nizam College”

Dr. Renu Razdan currently serves as Chief Operating Officer and is responsible for the oversight of all Operations and the Business Development Team in India focusing on Europe and South East Asia Regions. Since Joining Max Neeman, Dr. Razdan has played an active role in the development and growth of the company. She brings in 10 years of experience and prior to joining Max Neeman International, worked for 6 years with Ranbaxy Laboratories Ltd.

Dr. Razdan has pursued ICRETT Fellowship of UICC Geneva, an International agency for Research on Cancer Lyon (France) and G.S.F. Fellowship, at German Cancer Research Centre (DKFZ), Heidelberg.

Max Neeman International is a leading Contract Research Organization and the wholly-owned clinical research subsidiary of Max India.; a reputed business group which also includes Max Healthcare hospitals, health and life insurance organizations. For over a decade, Max Neeman has offered customized services to global pharmaceutical, biotech, device and nutraceutical companies in the conduct of drug and device trials. Data Management and Medical Writing services alone have touched 60 countries to date. Operating since 2001, Max Neeman is ISO certified for Site Management, Monitoring, Data Management, Information Security Management Systems and Clinical Investigation of Medical Devices with 6 regional offices, 200 sites across 43 cities, headquarters in New Delhi and RTP North Carolina based USA office.

Max Neeman has been awarded 285 trials and 80% of >300 employees are M.D.’s trained in ICH GCP guidelines.

Services include:

• Project Management
• Regulatory Submission
• Site Monitoring
• Clinical Data Management
• Biometrics and Report Writing
• Site Management
• Device Importation, Warehousing & Distribution

The complimentary live webinar is offered on two different dates/times for your
convenience (duration: 60 minutes plus Q&A session)

Wednesday, Sept 26 @ 11:00am EDT (N. America)
Hover here for timezones

Thursday, Sept 27 @ 1:00pm IST (India)
Hover here for timezones