2014 Archived Content


Cambridge Healthtech Institute’s Third Annual 

Integrating and Leveraging Clinical Trial Operations Data: 

Portals, Data Warehouses, Site and Study Execution Metrics
February 5-6, 2014 | Hyatt Regency Miami | Miami, FL 

We are witnessing an unprecedented burst of technology that completely changes the way we run clinical trials. The paperless trial concept quickly became old news and we are now discussing sophisticated technical approaches to data management such as internet-based and cloud-based data management. CHI’s 3rd Annual “Integrating and Leveraging Clinical Trial Operations Data” will feature core eclinical technologies as well as user-centric approaches that make these technologies more effective. Special emphasis will be placed on the problems related to data acceleration, integration and accessibility in alliance partner models.

Day 1 | Day 2 | Track Brochure | Full Event Brochure 


12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


Data Integration And Aggregation 

1:20 Chairperson’s Opening Remarks
AnnaKravetsAnna Kravets, Director, Strategy & Planning, Merck & Co., Inc. 


1:30 KEYNOTE PRESENTATION: Pfizer’s Move to the Cloud – Clinical Aggregation Layer (CAL)

Munther BaaraMunther Baara, Senior Director, Development Business Technology at Pfizer


1:55 Clinical Data Challenges in the Alliance Partner Model

KennethMillsKenneth Mark Mills, Director, Clinical Scientific Data Warehouse, Pfizer

Transitioning from internal management of clinical trials to an external alliance partner model creates unique challenges with respect to clinical data. Ensuring easy access to consistent, high quality deliverables from data collection through reporting requires sound strategy, tools and processes. The presentation will provide insight into some of the key challenges and Pfizer’s approach for building a successful platform for clinical data access in the alliance partner model.  

Thomson Reuters-Large

2:20 Leveraging Global Clinical Trial Data for Trial Development and Implementation Strategies
LarissaComis-TisLarissa Comis-Tis, Director, Clinical Strategy, Thomson Reuters 
The proliferation of electronic clinical trials data creates a new opportunity to combine aggregate clinical data with global clinical trials information that includes bio markers, outcomes, endpoints, adverse events, mechanism of action. This will enable the identification of global clinical trial opportunities and white space that leverage the clinical characteristics of your company’s aggregate clinical data. This could provide fast insights into portfolio strategy that may have otherwise been undiscovered. 

2:45 Technology and Its Impact on Development and the Changing Role of the Data Manager

RamziNajmRamzi Najm, Vice President, R&D Information and Technology Management, Allergan

The use of technology in the support of Clinical Trials has continued to increase including solutions such as Investigator Portal, EDC, IRT and ePRO. Those tools have increased access to the clinical trial data and generally improved its quality.

3:00 Gaining Operational Intelligence: "Targeted Data" Innovations For Achieving Real-Time Data Insights
Neri_NickNick Neri, Vice President, Product Development, eClinical Insights
While the adoption of electronic data capture technologies has delivered significant advances in how data are captured and stored, it has also contributed to a critical business challenge the industry faces today: trial data is fragmented across the eClinical continuum, and companies are struggling to put it back together in an automated way. This presentation will explore the difference between top-down Big Data strategies and "Targeted Data" innovations for achieving real-time operational intelligence at the trial level. 


3:25 Refreshment Break in the Exhibit Hall


Data Integration And Aggregation (continued) 

4:00 Chairperson’s RemarksSteven P. Sweeney, Vice President, Head of Clinical Development Operations
Arteaus Therapeutics

4:05 CAT – A Next Generation Platform for Document Authoring and Review at Novartis

JohnWalkerJohn Walker, Director, NIBR IT, Novartis Institutes for BioMedical Research, Inc.

The clinical development process requires the collaborative authoring and reviewing of many documents. Managing the content, format and versioning of these documents is a challenge. CAT is a new web-enabled way to collaboratively author and review the documents associated with a clinical submission, removing the need for complicated document managing systems. CAT provides the authors with significant automation and re-use capabilities through the use of novel graphical user interfaces.

4:30 PANEL: Comparing Various Data Integration SolutionsModerator: Steven P. Sweeney, Vice President, Head of Clinical Development Operations
Arteaus Therapeutics
Speakers of the Session

5:20 Networking Reception in the Exhibit Hall

6:20 End of Day

Day 1 | Day 2 | Track Brochure | Full Event Brochure 

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PRA Health Sciences


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