Project Management Featured Articles
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The Changing Role Of CROs
7/25/2016
Sponsors can have wide-ranging relationships with their CROs, from strategic partnering arrangements all the way down to the more simplistic transactional models. Regardless of the model in place, how do sponsors actually view the role of CROs in clinical development? A recent survey by Worldwide Clinical Trials attempted to answer that question.
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3 Steps For More Effective Sponsor-CRO Partnerships
5/31/2016
Clinical Operations (ClinOps) leaders increasingly outsource critical components of their trials. By one estimate, 75% of pharmaceutical and biotechnology companies are now outsourcing data management and over 70% are outsourcing site operations. As a consequence of the growth of this practice, effective collaboration between Sponsors and their CROs has never been more critical for achieving clinical trial milestones on-time and within budget.
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As CROs Merge, How Should You Assess And Manage Your Partners?
5/20/2016
Consolidation in the life sciences industry is a fact of life. The recent merger of Quintiles and IMS Health is just the latest in a string of consolidations. Research firm ISR Reports anticipates the merger activity will continue, with large CROs adding companies with complementary services and midsized CROs attempting to quickly gain scale. For sponsors, is this a good time to reevaluate existing CRO relationships?
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Getz: Site Activations Hurt By Commodity Mentality
5/16/2016
Site activation in clinical trials is not an efficient process. Those inefficiencies delay the start of trials and are costly to sponsors, CROs, and sites. But more importantly, they keep medicines from getting to patients in a timely manner. Many of the issues are ones that investigative sites have been vocalizing for some time, but which sponsors and CROs have been slow to hear.
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Site Payment Systems And Processes for The 21st Century
4/14/2016
Sites suffer from the administrative burden and financial stress placed on them due to slow and inefficient payment processes. Sponsors and CROs struggle with payment delivery complicated by antiquated systems, compliance regulations, global reporting, multiple payees, and complex protocols. New strategies and solutions are available to Sponsors and CROs to solve these challenges thereby improving site cash flow and freeing up site personnel to focus on the patients.
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Julian Jenkins Joins Clinical Leader Editorial Advisory Board
1/6/2016
Dr. Julian Jenkins, VP and Head of Innovation, Performance and Technology within the Projects, Clinical Platforms & Sciences (PCPS) group in GSK Pharma R&D, has agreed to join the Editorial Advisory Board for Clinical Leader. Dr. Jenkins is accountable for performance management, business strategy and operations, and change management for PCPS, while maintaining a state of the art clinical and project technology infrastructure for the Pharma clinical organization.
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Quintiles Chairman Reflects On 33 Years In Drug Development
12/8/2015
On December 31, 2015 Dennis Gillings will officially step down as the Executive Chairman of Quintiles. When Gillings began working with pharma companies in 1974, shortly after coming to the U.S. from England, he was a professor of biostatistics at the University of North Carolina at Chapel Hill. His career in pharma started when he received a call from Hoechst, which later became Aventis and, subsequently, Sanofi
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The Challenge Of Vendor Selection, Cost Overruns, And Change Orders
10/23/2015
If you are in charge of clinical operations for a small pharma or bio company, you are likely very familiar with the challenges and frustrations associated with vendor selection, vendor management, timeliness, cost overruns, and change orders. I recently had the opportunity to speak with the director of clinical operations for a small pharma company that currently has assets in Phase 1 trials. Although he has spent a good amount of his 20-year pharma career working in Big Pharma, he was able to give me a nice perspective of the challenges he faces in his current company, and how he is attempting to overcome them.
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Lessons Learned From A Venture Into Risk-Based Monitoring
8/12/2015
Last year Trevena decided to undertake its first study incorporating risk-based monitoring (RBM). According to Ruth Ann Subach, director of clinical operations for Trevena, the approach was sexy and trendy and seemed to be what everyone was talking about. But having never done it before, she had a lot to learn. In this article, Subach takes you through the CRO selection process, documents she used throughout the trial, the decision-making process, lessons learned from the study, and the cost savings experienced by her company. Would she do it again? “Absolutely,” says Subach.
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Centralized Monitoring: A Smarter, Cost-Efficient Approach To Clinical Quality
3/24/2015
As complexities in clinical trials have increased significantly in the last few years, the clinical monitoring cost and, in turn, the trial management cost have risen significantly in order to achieve higher data quality and better monitoring of patient safety. Therefore, there is a need to develop a smarter and complementary approach to achieve effective study data monitoring.