2013 end of year holiday hours

Our office will be closed  December 24th, 25th, 31st and also on January 1st for the holidays. There will be an IRB Board meeting December 23rd .  The week of January 6th, the normal IRB Board meeting schedule will resume. If you need to talk to us about your need for...

Article from Pearl IRB staff featured in SCRS InSite magazine

Check out this article (login registration is required) entitled “What could proposed changes to the Common Rule mean to sites, sponsors and IRBs” published in the Q2 2013 edition of the Society for Clinical Research Sites’ online journal, InSite. ...

Job opening – Regulatory publication coordinator

We are looking for a new talent to join the Pearl team.  Effective immediately, Pearl Pathways in Indianapolis, Indiana has a new position open for a Regulatory Publication Coordinator.  Please see the job description online here.  Experience with eCTD for an NDA or...

FDA issues final guidance on risk-based clinical trial monitoring

The final FDA guidance entitled “Guidance for Industry Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring,” issued early August is similar to the draft guidance published in 2011.  FDA encourages risk based remote monitoring,...