Cambridge Healthtech Institute’s Inaugural  

Clinical Trial Project Management
for Outsourced Clinical Trials

Improving Outsourcing Partnerships
February 25-26, 2015 | Hyatt Regency Orlando | Orlando, FL

As the biopharmaceutical industry moves toward more outsourcing of clinical trial activities to contract research organizations (CROs), sponsors must effectively manage their in-house activities in addition to the needs of their CRO partners. Effective management of outsourced clinical trials requires realistic and explicit expectations from each partner in the outsourcing relationship. Cambridge Healthtech Institute’s “Clinical Trial Project Management for Outsourced Clinical Trials” conference features case studies and lessons learned from sponsors and CROs on how to optimize the outsourcing partnership to achieve more efficient clinical trials.

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Clinical Trial Forecasting & Budgeting

Wednesday, February 25


1:25 pm Chairperson’s Remarks

Joan ChambersJoan Chambers, COO, CenterWatch


1:30 Leveraging Project Management to Build Strong Partnerships

Thomas LawlerThomas Lawler III, MBA, PMP, Senior Director, Global Project Management, AstraZeneca

Building valuable partnerships is reliant on building strong relationships as well as fit-for-purpose infrastructure to support inevitable breakdowns that occur during project delivery. Use of sound project management practices greatly increase the chance for success in relatively simple and pragmatic ways. The presentation covers: 1.Project Planning and its critical role in setting expectations 2.Risk and opportunity management versus being experts at resolving issues 3.Tracking to plan in place of traditional metrics approach 4.Scope management as an alternative to managing change orders.

1:55 Optimizing Outsourcing Relationship Models

Mary-Jo-LambertiMary Jo Lamberti, Ph.D., Senior Research Fellow, Tufts CSDD, Tufts University

Tufts CSDD has conducted a study among top 10 biopharmaceutical companies to capture specific use of outsourcing models (e.g., niche, full-service, FSP, integrated alliances). In this study, Tufts CSDD analyzed specific collaboration and risk-sharing models being utilized, their impact on performance and efficiency to date. The study also explores ways in which organizations have adapted their collaboration models to achieve greater efficiencies and best practices. The study benchmarked the incidence and impact of various organizational approaches through gathering company study data.

2:20 Leveraging Governance Committees and Scorecard Results to Optimize CRO and Sponsor Relationships

Rosemary Dillon, Associate Director, Clinical Outsourcing & Operations, Bristol-Myers Squibb

This presentation will discuss the importance of Governance Committees and Scorecards to achieve strong and productive partnerships with our CROs. The presentation will illustrate the need for Governance and Scorecards in setting realistic expectations, identifying trends, strengths and weaknesses and working as true partners to achieve speed to patient goals.

2:45 Q&A with Session Speakers

3:15 Refreshment Break in the Exhibit Hall


4:05 Chairperson’s Remarks
Kleger_BrettBrett Kleger, Chief Commercial Officer, DrugDev



4:10 Avoiding Duplicative Efforts between Sponsor and CRO

TeresaPipernoTeresa Piperno, Associate Director, Clinical Trial Management, Novartis Vaccines and Diagnostics

This presentation would cover: 1. How to work effectively and efficiently with a CRO partner on a clinical trial. 2. Methods to making the best use of time between CROs and sponsors and to ensure minimal overlap on activities. 3. How to set up the relationship early on to ensure a successful collaboration.

4:50 The Critical Role of "Contracts & Outsourcing" in Study Delivery

Réne Stephens, Executive Director, Global Head, Global Contracts & Outsourcing Management (GCOM), Astellas Global Development

5:15 Shifting the Focus of Your Operating Model from Execution to Oversight in a Strategic Partnership Model

Jeanie PriceJeanie Price, Principal Clinical Trial Leader, EMD Serono







KarenBureauKaren Bureau, Director, Clinical Project Management, Quintiles

This section will focus on the evolution a Clinical Trial Management team must undergo to move the core competency from an execution (traditional master-servant) midset into an oversight (collaborative) culture in which the audit/ inspection trail no longer starts and stops within the sponsor but must follow the trail into the CROs systems/ processes/ etc...

5:40 Reception in the Exhibit Hall

7:00 Close of Day

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Clinical Trial Forecasting & Budgeting

Thursday, February 26

Drug Dev7:30 am Breakfast Presentation: How One (Golden) Number Can Transform Clinical Trials

Elisa Cascade, MBA, President, Data Solutions, DrugDev

For years pharmaceutical companies and CROs have struggled to collect, clean and collate site data from disparate sources so they can make better decisions about site feasibility and selection. With the DrugDev Golden Number - a universal identifier for Investigators and sites - individual pharma companies and CROs easily match and master data, and share data across collaborations like the Investigator Databank and TransCelerate. While the Golden Number began as a method for data sharing, innovators are using it to drive operational efficiencies, collaboration and integrated reporting as well. We expect it also will give regulators a more detailed view into the global investigator community, which ultimately can improve patient safety. Join this session for a discussion on the Golden Number and how it can help pharma, CROs and sites do more trials.


8:15 Chairperson’s Remarks
Rizk_MaryAnneMaryAnne Rizk, Ph.D., Global Head, CRO Partnerships, Alliances & Channels, Oracle Health Sciences

8:20 CO-PRESENTATION: Improving Outsourcing Partnerships

SondraSmymiosSondra Smyrnios, Vice President, Clinical Operations, Alkermes

Susan SeroskieSusan Seroskie, Executive Vice President, Advanced Clinical


Strong service provider oversight and healthy relationship management make the difference between success and failure in clinical trial execution. This session balances the sponsor’s and the service provider’s views on: 1. Designing and implementing service provider-sponsor relationship management, 2. Building operational oversight infrastructure within the sponsor organization, 3. Empowering functional teams to resolve operational issues vs. prematurely escalating to functional and senior management, 4. Highlighting the importance of having clear communication pathways and building trust.

9:10 PANEL DISCUSSION: Managing Clinical Trials Together: Setting Realistic Expectations for Outsourced Deliverables between Sponsors and CROs


Thomas LawlerThomas Lawler III, MBA, PMP, Senior Director, Global Project Management, AstraZeneca



Shailesh Chavan, M.D., Senior Director, Clinical Research, Medical Affairs & Drug Safety, Biotest Pharmaceuticals Corporation

Karen Bureau, Director, Clinical Project Management, Quintiles

Rosemary Dillon, Associate Director, Clinical Outsourcing & Operations, Bristol-Myers Squibb

One of the biggest impediments to successful clinical trial execution is setting realistic and explicit expectations for deliverables between sponsors and CROs. Clear accountability and communication are key to successful outsourcing partnerships.

Topics discussed include:

  • Setting realistic and explicit expectations for the quality and scope of outsourced deliverables
  • Establishing clear assignments on accountabilities and responsibilities
  • Frameworks issue escalation and resolution
  • Setting and defining communication pathways and expectations

10:00 Coffee Break in the Exhibit Hall

10:40 Closing Plenary Keynote

1:10 pm SCOPE 2015 Conference Adjourns (see you in Miami for 2016!)

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Clinical Trial Forecasting & Budgeting

Signature Sponsor

Bio Clinica Logo

Premier Sponsors





PRA Health Sciences


> All Sponsors

> Media Partners

> 2016 Attendee List

> 2016 Attendee Profile