Tag Archive: Phase 3

Feb 15

Everything You Need to Know About Priority Review Vouchers: Part 2 of 2

The Rare Pediatric Disease PRV, the Difference in the PRVs, and the Future of the Program The Rare Pediatric Disease Priority Review Voucher (If you haven’t read Part 1 yet, start there first!) A new Priority Review Voucher (PRV) has been introduced that could be a game changer with respect to the program.  Nancy Goodman …

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May 02

Cato Research Canada Celebrates Two Decades of Success in the Drug Development Industry

Over the past 5 years, the life sciences industry throughout Canada, and especially in Québec, has been extensively challenged. Capitalizing on strong relationships built over years with clients and partners has helped Cato Research continue to provide excellent services and weather the industry’s roller coaster ride. On 03 May 2012, Cato Research Canada will celebrate its 20th anniversary with a celebratory wine tasting. You are invited to join us and other industry representatives to talk about the changing climate for pharmaceutical and biotechnology companies in Canada.

Mar 20

Senator Hagan’s TREAT for Small Biotech

Image via www.dog-paw-print.com Beginning with the Pure Food and Drugs Act of 1906, legislation proposed by Congress has constructed and continues to modify the FDA.  By extension this legislation represents the rulebook that biotech plays by in its pursuit of advancing drugs to market.  Longtime biotech advocate, Senator Kay Hagan (D-NC) has proposed the TREAT …

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May 26

Conference Recap – 2011 ACRP Global Conference and Exhibition

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals.

Feb 28

Recap of the 20th CED Biotech/Life Sciences Conference

The 20th Annual Council for Entrepreneurial Development (CED) Biotech/Life Science Conference was held on 21-22 February 2011 in Raleigh, North Carolina.

May 24

When Should You Write your Statistical Analysis Plans?

Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of study. I find this unusual. Any experience doing so? When? As of the time of …

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Apr 07

Tips for your Special Protocol Assessment

A number of scientists with greatly different backgrounds can come up with completely different assessments. – Richard Leakey One question that we hear frequently is:  Can we apply for a Special Protocol Assessment (SPA) for our Phase 3 trial?  The answer is always “Yes, you can apply.”…but should you?  That is an entirely different question. …

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