Clinical Protocol Development Track 

Virtual Investigator Meeting Management Track 

Clinical Training Forum Track 

Clinical Project Management Forum Track 

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Day 1  |  Day 2 | Download Conference Brochure | Short Courses 


7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee



8:25 Chairperson’s Opening Remarks

Paul Hoskins, Head, Clinical Operations and Preclinical Outsourcing, Galleon Pharmaceuticals

8:30 Partnering Often and Early in Protocol Development: Why Operations Can Make Your Life Easier

Amy Ronczka, Senior Clinical Protocol Manager, Global Clinical Operations and Strategy, Bristol-Myers Squibb

What good is a well-thought-out, scientifically rigorous study if it’s impossible to pull off? Partnering with an operations expert early in the process helps you identify areas of your protocol that will cause issues with HA/IRBs/EC approvals, patient consent, budget and overall feasibility. The best chance of success is to consider operational feasibility to be just as important as scientific/regulatory rigor, because if the study can’t be completed, you don’t have the data package to submit.

Sponsored by
9:00 How Structured Protocol Enables Optimized Study Design via Simplified Cross-Functional Collaboration
Michelle Marlborough Michelle Marlborough, Senior Manager, Product Management, Medidata Solutions
As protocol complexity and trial costs grow, strategies for analyzing, justifying and reducing cost and complexity are becoming increasingly important. With traditional study design and protocol authoring, the relationship between the procedures conducted at site and the purpose for their inclusion in the protocol are difficult to interpret. This presentation will analyze how structuring study design to allow cost and complexity to be viewed alongside study objectives and endpoints can enable organizations to challenge design.

Sponsored by


9:30 Best Practices for Accelerating Protocol Amendment Adoption

Co-Presentation: Penny Carlson, Global Clinical Program Manager, Consultant, Genzyme, Inc. & Suzanne Collins, Director of Operations, Trifecta Multimedical

One of the most frustrating tasks for study teams, sites and ultimately patients is the addition of a Protocol Amendment. What are the reasons behind these changes?  What elements of the study really have to change? Who does that effect? Is it the subject and their commitment to the study? All of these questions can be easily addressed, if you have a strategic communication plan in place.

10:00 Networking Coffee Break in the Exhibit Hall

10:45 Predicting and Managing Amendments: Lessons Learned from a Major Academic Research Institution

Laurie Lebo, Ph.D., CCRP, PMP, Research Services, Vanderbilt University Medical Center

In most cases, a protocol amendment extends the study timeline, increases study cost, slows recruitment and delays results. This session will use metrics to summarize data from protocol amendments submitted to an IRB at a major academic institution. This information will be used to create a communications and risk management plan for predicting and managing amendments. We will use lessons learned from real-life protocols to identify key stakeholders, plan effective communications, identify risks, plan risk responses, perform integrated change control and anticipate future amendments. While all amendments cannot be avoided, applying basic project management best practices to protocol implementation can prevent some amendments and mitigate risks associated with necessary protocol amendments.

11:15 Case Study: Strategies, Best Practices, and Lessons Learned when Outsourcing Protocol Writing to Partners

Rhonda BenottiRhonda Benotti, Business Manager, Strategic Outsourcing, Genentech, Inc.  



11:45 Sponsored Presentation (Opportunity Available)
(Please contact Ilana Quigley:

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:25 Chairperson’s Remarks

Suzanne Collins, Director, Operations, Trifecta Multimedical

1:30 Protocol Writing Techniques for Successful Recruitment

Nariman NasserNariman Nasser, Director, Participant Recruitment Service Clinical and Translational Science Institute, University of California, San Francisco

Proactive analysis of population cohorts and co-morbidity prevalence can provide valuable information for writing a protocol that can be realistically recruited. Simple measures enacted during the protocol concept stage will ensure fewer protocol amendments and greater chance of trial completion, in addition to better quality data. Key topics to be covered include: Analytical approaches to identifying appropriate inclusion/exclusion criteria; Effective tools for proactively determining reasonable recruitment goals; Tips for ensuring the population profile meets the trial objectives.

2:00 Pitfalls Discovered by the Site

Kim_TalbotKim Talbot, Site Director, Professional Research Network of Kansas

Protocols are written by high-level scientists with the best intentions to find valid evidence to support hypotheses. They are written in such a way as to be able to measure and support objectives; however “the road of life is paved with good intentions.” When the time comes to execute the protocol, what we find is that the particulars for the logistics are unclear or the practicalities the protocol requires are not always possible. This leaves a site unable to safely proceed with the study without further clarifications. These clarifications, which come from the study team in lieu of or in absence of a protocol amendment, leave the site and the investigator out on the proverbial limb. This session will bring forth scenarios experienced by one site from several different sponsors that demonstrate this conundrum.

2:30 Afternoon Refreshment Break in Exhibit Hall



3:15 How Do I Get There from Here?

Cheryl VitowCheryl Vitow, President, Medical Writing and Clinical Management Consulting, CliniQuill Associates, LLC

The protocol is the backbone of the clinical study program. Without a clear, concise protocol, there is a risk of unreliable data generation. More importantly, even if the data generated are reliable and sound, what if the data don’t answer the questions the protocol was asking? The generation of a sound protocol is part people management and part medical writing. These two important pieces must be in sync for the process to work. Attendees will learn about protocol development along two lines: Firstly, they will learn about the document itself and gain an understanding that a protocol is designed to answer a specific question or questions, and how to focus on developing a document that starts out with an understanding of what those questions are and the best ways to institute the writing process to make that happen; and secondly, they will learn that the team of cross-functional personnel are involved in this process. Managing that process and coordinating their input are also integral to a successful protocol. The audience will leave with tools to better manage their document and their team.

3:45 Early Clinical Development Protocols: Optimizing Use of Pre-Clinical Data for Study Design and Enabling Later Stage Development

Paul Hoskins, Head, Clinical Operations and Preclinical Outsourcing, Galleon Pharmaceuticals

Key for first-in-man (FIM) study design is incorporating relevant safety data from preclinical programs. Additionally, FIM studies must be designed to support later stage development. Ensuring subject safety while designing effective FIM protocols that demonstrate benefit to the development program goals should be the primary goal. It is possible to incorporate preclinical safety and efficacy data to run robust FIM studies enabling later stage programs. Results should provide ethical and safe exposures to study subjects, and enable early go/no-go decisions for clinical development teams.

4:15 Topic to be Announced

4:45 Closing Remarks

5:00 End of Clinical Protocol Development


Stay on for Clinical Project Management and Clinical Training Forum (October 5-6)


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