Project Management Featured Articles

1. Are You Conducting Proper CRO Oversight? 3/2/2017

   Are my CROs doing what I hired them to do? That is a question you may have asked yourself many times. Even if you have conducted a thorough CRO search and selected the one that best meets your needs, there is no guarantee it is performing the tasks most important to your clinical trial.

2. How Many Team Members Does It Take To Determine The Study Status? 2/16/2017

   Sitting on one of those long, painful, study status update calls recently, I was reminded of the famous light bulb joke. You know the one: “How many engineers (lawyers, politicians, etc.) does it take to change a light bulb?”  I was both flabbergasted and frustrated that, after 45 minutes, the project manager was still wading through status updates from a myriad of CRO and vendor partners and CRAs — just to figure out where the study was from a site activation and enrollment standpoint.  

3. Are You Correctly Conducting Your CRO Qualification, Oversight, And Audits? 1/19/2017

   David Kim has spent most of his career working on clinical trials. His areas of expertise include implementing strategic alliances, leading and directing sourcing and vendor management teams, and partner negotiations. In this interview with Clinical Leader, Kim discusses the challenges of CRO qualification, oversight, and audits, and how to make sure you are not being overcharged for the work you outsource.

4. Are Outdated Pricing Models Hurting Clinical Research? 11/8/2016

   Two issues that always seem to throw a wrench into sponsor/CROs relationships are changes to staffing and pricing. Protocol changes can disrupt trials for CROs and cause price increases for sponsors. Staffing changes can create new learning curves, delay trials, and cause sponsors to feel they were misled. Are penalties an easy way to fix both?

5. Clinical Staff Shortage: “Growing Plague” For Pharma & CROs 11/2/2016

   Anyone involved with clinical trials knows a continuing and growing problem in the industry is the lack of qualified clinical research staff. A new report from BioPharm Insight (BPI) acknowledges this trend, noting the staff shortage is a “growing plague to the CRO industry which will need to be addressed in order to ease liabilities.”

6. The Benefits Of Outsourcing Clinical Regulatory Requirements 10/20/2016

   When I sat down to speak with Paul Bridges, Ph.D., corporate VP and Interim head of PAREXEL Consulting at the 2016 DIA Annual Meeting, we had recently heard the news of Great Britain exiting the European Union. Bridges seemed to take it completely in stride, noting there will always be changes occurring that can disrupt and erect obstacles to your drug development efforts. While we can’t stop them, we can certainly take advantage of the resources available from partners to better navigate them and mitigate their effects.

7. How Payment Automation Can Improve Site Satisfaction 9/29/2016

   I recently wrote an article that focused on the frustrations sites have with sponsors. Their greatest gripe, to no one’s surprise, is site payments. Sites receiving payments late, and receiving a check with no supporting documentation, can cause delays and frustration, especially for smaller sites that can’t float a payment for three months or longer.

8. CROs Can Be Indispensable As Pharma Companies Focus On Value 9/15/2016

   The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.

9. 3 Things You're Doing That Drive Your Sites Insane! 9/15/2016

   Many pharma companies have become focused on becoming a sponsor of choice. We believe this comes from the recognition that partnerships are a two-way street. In order for the industry to conduct trials faster, more efficiently, and at a lower cost, sites and CROs need to be better partners to pharma. At the same time, however, pharma needs to be a better partner to sites and CROs. Still, many wonder what it means exactly for a sponsor to be a better partner.

10. Survey: Do Spreadsheets Still Hamper Clinical Trial Speed & Quality? 8/8/2016

    Clinical trial operations is fraught with many hurdles, including quality, cost, and timeliness. To successfully bring new medicines to market, operations managers have to successfully overcome these challenges. Application software provider Comprehend recently produced a “Clinical Operations Benchmark Report,” in which it surveyed executives at leading life science companies. The goal was to determine how companies can speed up trials and more quickly get to quality results across a portfolio of products.