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Clinical Research Consulting, Inc Provides Clinical Research Monitoring Model That is Beneficial to Industry Sponsors by Lisa Mazurka |
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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. |
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Distributed: 2010-02-02 12:15:00 |
Word Count: 503 |
Page Views: 3678 |
Votes: 3 |
Rating: 0.33 |
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Will Training and Education Requirements Become Regulation for Clinical Research Professionals? by Lisa Mazurka |
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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. |
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Distributed: 2009-12-15 14:30:00 |
Word Count: 604 |
Page Views: 3918 |
Votes: 4 |
Rating: 1.25 |
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Developing a Quality Assurance and Compliance Program Within Your Organization by Lisa Mazurka |
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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. |
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Distributed: 2008-03-12 11:24:00 |
Word Count: 932 |
Page Views: 5053 |
Votes: 12 |
Rating: 2.17 |
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A Career Alternative by Lisa Mazurka |
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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. |
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Distributed: 2008-02-07 10:48:00 |
Word Count: 843 |
Page Views: 5207 |
Votes: 5 |
Rating: 0.20 |
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