the drug development process and the need for secure ... · the drug development process typically...
TRANSCRIPT
THE DRUG DEVELOPMENT PROCESS AND THE NEED FOR SECURE INFORMATION SHARING
The drug development process typically takes years, if not decades, with parallel R&D and financing tracks critical to success. Throughout, effective execution
rests on the ability to securely and efficiently share, store, search and review confidential information with potential investors, regulators, advisors and other
internal and external stakeholders.
How a Drug Comes to Market
R&D Basic Research Drug Discovery Pre-Clinical Phase I Phase II Phase III Phase IV
FINANCIAL (Sample - Mixed Tactics)
Angel Investment Series A Series B Series C Listing
Licensing Sale Partnerships
TRACKS PRE-CLINICAL CLINICAL TRIAL POST APPROVAL
The Complex Exchange of Confidential Information
HOW DATASITEONE CAN HELPWith 6,000+ projects a year and 450+ due diligence experts worldwide, we understand the unique challenges of bringing a drug to market in today’s complex regulatory market. Our best-in-class app for due diligence provides the highest global security, with multi-permission settings throughout to ensure tight control and document tracking down to the page level. GDPR compliant. Learn more:
US phone APAC phone EMEA phone+1.888.311.4100 email [email protected] merrillcorp.com+852 3905 4800 +44 (0) 203 928 0300
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DRUG DEVELOPMENT COMPANY
CONTRACT RESEARCH
ORGANIZATIONS (CROS)
DRUG REGULATORY AUTHORITY
PARTNERS & POTENTIAL
BUYERS
INVESTORS
+ IND & NDA submissions
+ Patent & IP
+ Clinical trials data
+ Patient information
+ Business documents
+ Financials
+ US: FDA
+ EU: EMA
+ China: CFDA
+ Canada: Health Canada
+ Japan: PFSB
+ Australia: TGA
+ Singapore: HSA
ADVISORS + Bankers
+ Lawyers
+ Consultants
MARKETING & DISTRIBUTION
+ Commercial agreements
+ CMC (Chemistry, Manufacturing, Controls)
SECURITIES REGULATORY AUTHORITY
+ US: SEC
+ EU: ESMA
+ China: CSRC
+ Canada: CSA
+ Japan: SESC
+ Australia: ASIC
+ Hong Kong: SFC