Project Management: Introduction to Tools and Templates

By: Melissa Harris, MPA, CCRP
Director of Interventional Resources & Clinical Trials Unit
Pennington Biomedical Research Center at LSU

Abstract: Project management involves many complex components and moving parts. Prior to initiating a clinical trial, various types of project tools and templates can be used to successfully plan and execute a clinical trial. This article highlights tools that are readily available for project management, including Microsoft Excel, Access, Visio, Outlook, and SharePoint, as well as Web-based applications. Monitoring progress through various tracking mechanisms ensures successful clinical trial execution from recruitment through retention and follow-up.

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Improving Communication in Clinical Research

Improving Communication in Clinical Research
By: Anatoly Gorkun, MD, PhD, Chartered MCIPD
            Senior Manager, Global Clinical Development, PPD UK

Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

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Virtual Project Management

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP
Senior Director, Project
Covance, Inc.

Abstract: Clinical research project management is increasingly conducted globally across multiple time zones and cultures. In order to be successful, certain adaptations must be made to routine practices. This article describes key terms and basic concepts of virtual project management, considerations for effective communication and collaboration tools, and ways in which the Project Management Institute knowledge areas can be applied to a virtual framework. Situational examples are provided. While this has been written in the context of clinical trials performed by a biotech or pharmaceutical sponsor engaging a CRO, the same concepts could easily be extended to any geographically dispersed project team.

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