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Wednesday, February 8

12:00 pm Conference Registration

Sponsored by
Clinical Financial Services 
12:00 pm Luncheon Presentation - Investigator Grant Payments are Not Just a Site Concern Anymore
Kevin Williams, M.B.A., M.S, Vice President, Corporate Development & Marketing, Clinical Financial Services (CFS)
For years investigator sites have expressed concerns around sponsors’ ability to make grant payments in a timely and consistent manner.  Now, compounding its sites’ concerns, many new challenges are facing Sponsors/CROs and driving them to take control of their grant payment processes including Sunshine Compliance, competitive pressures and the need for improved financial controls.  Understand the impact that the CTA and associated grant payment process can have on your ability to address these growing issues. This discussion will show you how to not only gain a competitive advantage for recruiting sites but also help deal with the mounting pressures related to paying your investigators.
(Bridging Session between Managing Post-marketing Studies (Phase IIIb-IV) and Registries & Clinical Trial Forecasting)


1:25 Chairperson’s Remarks
Andrew Grygiel, CMO, ClearTrial

Sponsored by
Clear Trial small logo
1:30 Effective Resource Planning: Reducing Clinical Project Risk and Cost
Molly Blake-Michaels, Senior Director, Clinical Services, ClearTrial
Accurate resource planning remains one of the biggest challenges facing biopharmaceutical and medical device companies today, with poor planning leading to increased project risk and higher development costs. This presentation will demonstrate how leading life sciences companies are leveraging effective resource planning to allocate resources efficiently for individual studies as well as across the project portfolio—reducing project risk, lowering their operating costs, and improving employee morale and productivity. Attendees will learn: how sponsors are making insightful, fact-based decisions to extract the most out of their resources in a constantly shifting operating environment; What methods deliver accurate resource forecasts at either the project or portfolio level, based on when the work will actually occur; How program planning, tracking project status, and reforecasting work together to enable effective resource planning.

2:15 Co-Presentation - Case Study: Aligning Project Strategy with Operational Execution of Clinical Trials

Simone Kraemer, Ph.D., Manager Business Capabilities, Bristol-Myers Squibb Co.

Melquíades (Mel) de Jesus, Director, Business Capabilities, R&D Operations, Bristol-Myers Squibb Co.

Bristol-Myers-Squibb (BMS) has made substantial strides integrating the drug development project team plans with making the Clinical Trial Management System CTMS) to assure the necessary resources are available to execute the work. This includes business processes and supporting systems to align the dates and drivers across the planning and operational systems. The integration has provided greater transparency between headquarters and the country. The case study address a real world planning challenge using two “off-the-shelf” systems: one strategically focused system to support enterprise-side planning, and an operationally focused system to support tracking and execution of a global clinical trial. The benefits of integrating macro schedules and planning tools to forecast resources with a clinical operation tool to close the loop between headquarter dreams with country specific realities will be discussed.

2:45 Refreshment Break in the Exhibit Hall


3:10 Chairperson’s Remarks
Andrew Grygiel, CMO, ClearTrial

Sponsored by
3:15 Raiders of the Lost Protocols
Michelle Marlborough Michelle Marlborough, Director, Product Management, Medidata Solutions
Faced with the challenge of building more complicated studies simply, clinical planners should be thinking of themselves as protocol archaeologists. Digging deeper into past protocol data can uncover behavior to replicate or avoid in future studies. But without a structured approach to protocol design, trying to find the right data is a fool's errand. This presentation will explore analytics for protocol and study design. It will unearth best practices for leveraging structured protocol, reviewing existing data, and implementing findings.

3:40 Successfully Applied SMART Principles of Budget Forecasting in Complex Advanced Clinical Programs

Wolf-Ulrich Nickel, Ph.D., Project Head, External Disease, Alcon Laboratories, Inc.

Budget forecasting appears to be still an “art or a constant challenge” for Clinical Trial Managers, Study Director and Program Managers with critical consequences for the entire enterprise success. As time and quality will be usually not sacrificed, the budget for external clinical costs and the resource allocation fall victim to expectations. Successfully applied SMART Principles via a financial breakdown structure will be presented from a sponsor perspective based on real life scenarios in advanced clinical programs. This will be a presentation from a practitioner’s view with lessons learned on the way to better accuracy.

Sponsored by
4:05 The Clinical Trialist's Wind Tunnel:  Simulation Modeling for Optimizing Design of RCTs and Registries
Badri Rengarajan, M.D., Medical Director, Archimedes, Inc.
Before building and flying an airplane, the design is tested several times over in a wind tunnel.  Mathematical simulation allows you to test trial designs before implementing them. You can forecast eligible population size and baseline event rates, and anticipate trial performance under different variations in inclusion criteria, protocols, and patient behavior. 

4:20 - 5:30 Interactive Breakout Discussion Groups

Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE 36: How Can Project Management Contribute to Better Budget Forecasting?

Moderator:  Wolf-Ulrich Nickel, Ph.D., Project Head, External Disease, Alcon Laboratories, Inc. 

• Combining timelines with budget - is it possible?
• Functional input into the process
• Risks of a too-conservative budget

TABLE 37:  Preparing a Cover Analysis and Budget for Sponsors 

Kelly Willenberg and Beth DeLair, Independent Consultants & Owners, PharMed Alliance

• Why a coverage analysis is important when developing a clinical research budget
• Understanding and applying “standard of care” when developing a clinical research budget
• Suggested process for developing a clinical research budget

TABLE 38:  Technological Innovation in Site Payment Processes

Moderator:  Sam Whitaker, CEO, Greenphire, Inc.

• The status quo: deficiencies in the traditional payment process
• Technology driven innovation in clinical payments
• Data and Results

TABLE 39:  Optimizing Your Portfolio: Translating Target Claims to Study Design and Portfolio Management

Michelle Marlborough, Director, Product Management, Medidata Solutions

A discussion on current and future practices designed to:
• Improve your studies' achievement of value claims
• Assess the impact of a value claim on your portfolio
• Refine your processes for portfolio optimization

TABLE 40: Preferred Site Partnerships

Moderator: Chris Hoyle, Executive Director, Elite Research Network

• What are the key elements of a preferred site partnership?
• What do sponsors, CROs, and sites hope to achieve with preferred site partnerships?
• Who within each organization is responsible for creating and maintaining the relationship?  
• Cost savings as a result of implementation.

TABLE 41:  Effectively Managing Resources: Driving Strategic Clinical Resource Planning and Capacity Management

Moderator:  Molly Blake-Michaels, Senior Director, Clinical Services, ClearTrial

• How are leading study sponsors forecasting and managing resources more effectively?
• What benefits are they seeing from doing so?
• What are some of the challenges (e.g., organizational, cultural, technological) facing efforts to implement these best practices?


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Social Media and Mobile Technology in Supporting Patients in Studies and Registries 


2012 Conference At A Glance 

Micah Lieberman 

For topic suggestions and
speaker referrals:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541-482-4709

Ilana Quigley 

For partnering and
sponsorship information:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781-972-5457

Rich Handy 

For media and association
partnerships, please

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456

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