Opportunity Targeting: Fostering Increased Participation in Clinical Research

Site feasibility and selection are complex decision-making processes, with geographic availability of sites represents only one of the factors used. While states with large populations naturally have larger numbers of active Principal Investigators, certain states with large numbers of physicians have a relatively low percentage of physicians actively involved in...

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CASE STUDY: ENSURING REGULATORY COMPLIANCE | ICH E6 (R2) Addendum | Optimizing Quality Risk Management

INDUSTRY CHALLENGE AND OPPORTUNITY: The recently revised ICH E6 (R2) Addendum provides both a challenge and opportunity for GCP organizations to modernize their QRM approaches.  By building quality in – starting with critical data & processes during  protocol development, using centralized and study risk-based monitoring, strengthening risk mitigation – organizations...

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Why do Clinical Studies Fail to Complete?

According to ClinicalTrials.gov, 3% (n=361) of all Phase 3 studies started from 2013 through 2017 terminated early. While that appears to be a relatively low rate, each of these instances represents millions to tens of millions of dollars in expenditure. Low Enrollment Highlighting the challenges with feasibility, incorporating Quality by...

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TayganPoint is Proud to be Re-Certified by WBENC as a Women Owned Business

TayganPoint Consulting Group was recently re-certified as a woman owned business by the Women’s Business Enterprise National Council (WBENC). This is the 9th successive year of affiliation for TayganPoint.  WBENC, founded in 1997, is the nation’s leading advocate of women-owned businesses as suppliers to America’s corporations. It is the largest third-party certifier of businesses...

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Social Responsibility: Life Science Leadership’s Next Secret Weapon

Entering Merck soon after Ken Frazier stepped down from President Trump’s Manufacturing Council, I was struck with newfound feelings of trust, connection and pride. Walking the halls, I found hundreds of people, from all backgrounds, ethnicities, ages enroute to contribute to Merck, it’s vision, and its mission. With recent events...

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The Do’s and Don’ts of Business Transformation

On Oct. 12 Healthcare Businesswomen’s Association hosted a panel exploring the successes and failures of business transformation in life sciences. The panelists, who have all thankfully lived to tell the tale, shared their transformation do’s and don’ts based on pitfalls and successes of their endeavors. Transformation truly touches every level of...

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