16 We take pride in our integrity as a company that improves people’s lives. We are devoted to maintaining top performance through teamwork . We value innovation in our products and leadershi p in our groups. We are committed to serving the communities around us. We are a corporation with a high respect for people and a sharp customer focus . These are our values at Pfizer.
A quick road map Gopal Pai, Ph.D. Head, Clinical Operations, Clinigene International Limited (A Biocon Company), Bangalore
Out-sourced / In-sourced / Combination Customer Focus Respect for People Integrity Innovation Teamwork Leadership Performance Community
Biography of a drug from its inception in the lab to its introduction to the consumer market and beyond.
Tests the drug for its efficacy and toxicity in humans
It continues throughout the lifetime of the drug to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the drug is released into the market and also into Pharmacovigilance where safety of marketed drugs, biologics or medical devices are monitored.
Clinical Development Phase I Phase II Phase III Phase IV
understand and appreciate the difference in academic and industrial standards of CR
skills of teaching and motivating students
Synopsis Reg. approval pre-study inv. meet Idea Idea Final Protocol Final CRF Drug Supply Inv. & site selection Final Report Safety Monitoring Data processing & analysis Close-out Inv. Meet & EC approvals Site Initiation Monitoring Audits & inspection
Project Manager SPONSOR REGULATORY BODY Senior mgmt approval Study Monitor Investigator Central Laboratory Patients Labs / Services Data management & Biometrics Vendors CRA CRA CRA CRA Ethics Committee
Hospital / Institute Investigator Contract Research Organization Sponsor
Consents provided by patients and their relatives at all hospitals
Insurance coverage in medical care
Narcotic drug use/abuse
Exposure to sunlight
Daily dietary components (pediatric, adult)
Is Clinical Research any different ?!
… NOW PERCEIVED AS A GUINEA PIG SYNDROME ! Help !!! Help !!!
Pre-World War II Empiric Rx Evidence-Based Medicine Personalized Medicine Post-World War II … the future?
as much “ art ” as it is “ science ” much of evidence-based medicine is a “ gold-standard in treatment approaches”, keeping the "art" aspect in mind … is as good an approach as any to determining whether evidence-based medical study results are useful to you as you and your doctor consider possible treatment for whatever your medical problem is. “ Art” factor