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


OPTIMIZING OUTSOURCING RELATIONSHIPS

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 Determining the Right Outsourcing Strategy

Speaker to be Announced

2:45 Sponsored Presentation (Opportunity Available)

3:15 Refreshment Break in the Exhibit Hall
 


EFFECTIVE PROJECT OVERSIGHT OF OUTSOURCED CLINICAL TRIALS

4:05 Chairperson’s Remarks

4:10 Avoiding Duplicative Efforts between Sponsor and CRO

Mick RibeiroMick Ribeiro, Head, 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.


4:35 Sponsored Presentation (Opportunity Available)

4:50 Talk Title to be Announced

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 Price, Principal Clinical Trial Leader, EMD Serono

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

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


MEETING THE NEEDS OF EVERY PARTNER
IN AN OUTSOURCED TRIAL

8:15 Chairperson’s Remarks

8:20 CO-PRESENTATION: Improving Outsourcing Partnerships

Anca CopaescuAnca Copaescu, Senior Director, Clinical Outsourcing and Analytics, BioMarin

 


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.

8:45 PANEL DISCUSSION: Managing Clinical Trials Together: Setting Realistic Expectations for Outsourced Deliverables between Sponsors and CROs

Moderator:

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

 

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

9:35 Sponsored Presentation (Opportunity Available)

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 

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