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All Articles Written By: Lisa Mazurka

1.   Clinical Research Consulting, Inc Provides Clinical Research Monitoring Model That is Beneficial to Industry Sponsors by Lisa Mazurka
    Numerous pharmaceutical and biotechnology organizations use contract research organizations (CROs) to outsource the service of monitoring clinical trials. Clinical Research Consulting, Inc. (CRCI) has a model that is unique than most industry CROs. Many CROs are finding this alternative approach beneficial and more cost effective. This article will discuss the CRCI monitoring service model, what makes it unique and why it continues to grow amongst industry sponsors.
    Distributed: 2010-02-02 12:15:00 | Word Count: 503 | Page Views: 3797 | Votes: 3 | Rating: 0.33
2.   Will Training and Education Requirements Become Regulation for Clinical Research Professionals? by Lisa Mazurka
    In July 2008, the Department of Health and Human Services (OHRP) asked the clinical research industry to provide public comment on whether the agency should develop regulations which would mandate education and training requirements for clinical research professionals or whether additional guidance on the topic should be provided (73 Fed. Reg. 37460). This article will review some of the specific questions OHRP requested for public comment, the public response and any action by OHRP to date.
    Distributed: 2009-12-15 14:30:00 | Word Count: 604 | Page Views: 4068 | Votes: 4 | Rating: 1.25
3.   Developing a Quality Assurance and Compliance Program Within Your Organization by Lisa Mazurka
    Many sponsor organizations, clinical research sites and contract research organizations (CROs) are developing and implementing Quality Assurance and Compliance Programs to assure adherence to company and institutional standard operating procedures, compliance with FDA Regulations, GCP Guidelines and protection of human research subjects. Implementation of such programs can improve the conduct of clinical trials and assure accurate, compliant data prior to submission to the FDA. This article will discuss the reason for increased growth in this area, the common types of QA audits and why and how organizations are implementing these programs.
    Distributed: 2008-03-12 11:24:00 | Word Count: 932 | Page Views: 5197 | Votes: 12 | Rating: 2.17
4.   A Career Alternative by Lisa Mazurka
    With the increasing demands in nursing today, many nurse practitioners are seeking alternative careers to utilize and compliment their current degrees. Numerous nurses are pursuing career alternatives as Clinical Research Coordinators; individuals who aid in the coordination, management and conduct of clinical research under the supervision of a designated physician/investigator.
    Distributed: 2008-02-07 10:48:00 | Word Count: 843 | Page Views: 5352 | Votes: 5 | Rating: 0.20

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