Outsourcing laboratory based services : inventing a new future for R & D and testing

Cover
Contents
CHAPTER1 GLOBAL OUTSOURCING IN KNOWLEDGE ECONOMY
	Intellectual Capital Gains
	The Rise of Services
	Down to the Core
	Outsourcing—Perfect Storm Brewing Overseas
	Economics of Knowledge
	Laws of Migration
	And The Winner is …
	Namaste! Welcome to the New Frontier of Indian Outsourcing!
	India’s Innovation Infrastructure
	India’s Resources
	Outsourcing Laboratory Services—The Cont®act is Just the Beginning
	The Rise of Global R&D
	Outsource R&D?
	What, When and Where?
	Outsourcing Guidlines
	Now’s the time
CHAPTER 2 RESEARCH PROCESS OUTSOURCING: BEGINNING OF PHARMA CONT®ACTS
	Drug Discovery Path: Pipe Dreams
	Screening for Lead Role
	The Final Round of Trials
	Registration: The Finish Lin
	Advantage India: Target Site
	Kilo Labs
	Pharmacopoeal Testing
	Stability Studies
	Preclinical Testing: Animal Rights and Wrongs
	Clinical Trials: Challenges and Opportunities
	Regulatory Regime: Lagging Behind Schedule Y
	Good Clinical Practices (GCP)
	Medical Dignostic Services : Path-finders
	Monitoring Medical Devices
	Biotech R&D: Genie is out
	Traditional Medicine: Back to the Future
	Himalayan Task
	This is just the Beginning…
CHAPTER 3 OFFSHORE R&D LABS: CITADELS TO CLUSTERS
	Houses of Magic
	Why Innovators Go Offshore?
	The India Experiment
	Blue Chip Designs
	Automobile Giants on Fast Track
	Pharma Majors Discovering Better Health
	Bringing Good Things to Life
	Underwriters Laboratories Inc,: Setting Safety standards
	Why R&D is a Big Deal?
	Enter the Dragon: Chinese Challenge
	Vertical Limits
	Open Innovation
	Reinventing Corporate R&D
	Clustering Breeds Wealth
CHAPTER 4 TESTING FOR QUALITY? OUTSOURCING IS IN
	The Developing World of Standards
	Independent Test Laboratories: Thriving Amid Imperfections
	Testing Times: The Traditional role
	Technical expertise: Jump-start Solutions
	Integrity/Confidentiality
	Quality/Data Integrity: Off-the-Shelf Expertise
	Value for Money
	Infrastructure: One-stop Shop Choice
	Customer communication: Communicate, Collaborate and Capitalize
	Service is the Product: Moments of Truth
	Timelines
	Testing in Troubled Waters
	Going for Gold Standard
	Testing Holy Cow
	Antioxidant controversy: Scientists seek Standardization
	Mining for Data
	Materials: Strength of New Bonds
	Pollution-free Olympics 2008 in Beijing?
	Agri Exports: Testing “Sour” Grapes
	India’s First Ever Product Recall
	Setting Standards: Classical Style
	GM Crops : There is a Fly Gene in My Soup
	Being Part per Billion Smiles
	Creating Houses of Quality
CHAPTER 5: MEASURED ONCE, ACCEPTED EVERYWHERE….
	Metrology: The Land of Measurement
	Define
	Good Laboratory Practices (GLP)
	ISOlating Standards
	Measure
	Mapping the Land of Measurement
	To Err is to To Discover
	Measure of All Things
	Who is a Metrologist?
	Weigh to go?
	Time is Ticking Away
	Traceability
	Method Selection and Evaluation
	Documentation—Trailing Behind
	Chain of Custody
	Analyze
	Hitting the Mark
	Calibration
	Certified Reference Materials
	Uncertainty
	Extreme Measures
	Improve
		Round Robbins Testing
		Reducing Defects: Men in Black in action
		Corrective and Preventive Actions
		Internal Audits
		Management Reviews
	Control: Defining Moment
		Conformity Assessment
		Declaration of Conformity
		Certification
		Accreditation
	Mutual Recognition Agreement: Construction of Free Trade
CHAPTER 6: INVENTING FUTURE: CITIUS, ALTIUS AND FORTIUS
	Heads? … We win
	Mind the Gap
	When Candles Cost More Than The Cake…
	Fuzzy Divide
	Future of the Present
References
Index