All Posts Tagged With: "Clinical Trials"

Are You Ready for a Sponsor BIMO Inspection: Experiences from a Medical Device Sponsor and CRO’s.

DigitellInc posted the video:

View this Lecture for FREE by signing up at www.prolibraries.com View any number of our other 32000 sessions from over 350 conferences by going to www.prolibraries.com Speaker(s) Susan Rockwell, MEd Joseph Giorgianni Are You Ready for a Sponsor BIMO Inspection: Experiences from a Medical Device Sponsor and CRO’s Mock FDA Inspection – Association of Clinical Research Professionals ACRP Global Conference & Exhibition 2009 The Association of Clinical Research Professionals (ACRP) 2009 Global Conference in Denver, Colorado had the highest quality programming to date. View over 180 online learning tools regarding Regulatory Issues, Clinical Study Management, Education in Clinical Research, Global Issues of Clinical Trials, Human Subject Protection and other areas pertaining to the issues. To review the Continuing Education statements, please click here. 2009 content accessed/purchased is available through June 1, 2011 – regardless of access/purchase date. This session describes a case history of a CRO conducting an unannounced mock FDA inspection at a medical device company. Representatives from both the CRO and the device sponsor will share their experiences, including preparing for and conducting a mock inspection (CRO) and responding to and follow-up from a mock inspection (sponsor). 26083c967ba7968aa464b941e9df9a96

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Israel Clinical Trials Services, Pharmaceutical and Medical Device Product Approvals

BlabNet posted the video:

www.Synergy-CRO.com The news today leads off with the announcement by New Jersey based firm Synergy Research of its Israel Clinical Trials services. Its goal: to help the pharmaceutical and medical device industry avoid costly delays in early clinical trial development programs, in highly regulated environments such as the US and European Union member countries. The dramatic shifts in the last decade, from US to Europe, then back to US, alongside with shifts to less western style countries, is evidence of the increasingly regulated environment for early and first in man clinical trials. These conditions drastically extend timelines, increase costs, reduce patent life, prolong development life cycles, all spelling out to lost revenues on R&D efforts. Synergy Research has taken extensive strides towards tapping in to a western style healthcare environment, with a diverse population, well suited towards early and first in man clinical trials. Israel is a no-nonsense appropriately regulated environment, perfectly structured for the early R&D life of drugs and devices. Synergy Research conducts clinical trials in Israel, under GCP & ICH conditions, under INDs & IDEs. American clinical & regulatory staff execute and manage all programs conducted in Israel. All leading to the best possible data, under the most demanding standards, well under the time and costs for comparable studies conducted in the US or Europe.

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