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Clinical Trials: What you need to know about Data Management

Emanate Life Sciences

Wednesday, March 21, 2018 from 5:30 PM to 8:00 PM (PDT)

Clinical Trials: What you need to know about Data...

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Type End Quantity
General Admission Mar 21, 2018 Free  

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Event Details

Collaborations in Clinical Research is a panel discussion and networking series that brings subject matter experts together from research sites, medical device, biotech, pharmaceutical and technology companies together to discuss clinical research topics that are timely and actionable in the workplace.


Event description

When you start a study, hear terms like database builds, CRFs (case report forms) specifications, edit check specifications, data validation specifications, user acceptance testing, system go-live, user & site Management, software validation, CCG’s (CRF Completion Guidelines), data management plan, clinical review plan and a variety of other terms.

You may find yourself asking what does this mean?  Am I completing this activity, correctly?  Is this my responsibility, I thought the CRO is supposed to complete this activity?    If you ever find yourself asking these kinds of questions, this event is for you.   

This is the first of multiple events, where we will take a moment to explain data management activities and basic best practices even if you don’t have data management department in-house.


An event sponsored by 





Panelist  Karen Green | Senior Director, Clinical Data Management, Forty-Seven, Inc


Karen Green is currently Senior Director, Clinical Data Management at Forty-Seven, Inc.  She has over twenty years’ experience in the pharmaceutical and biotech industry in Clinical Data Management. Karen is an accomplished leader of in-house staff and service provider personnel working to ensure clinical data management deliverables are on time and on budget for phase 1 through phase 3 clinical studies in Oncology, Cardiology, HIV, Virology, Gastroenterology and Immunology.  She has worked at companies such as PDL, Amgen, Onyx, Acerta and Abbott, where she has lead or contributed to the establishment of CDM Standards (CRFs, SOPs, templates) and numerous cross functional process improvements.  


Panelist  Gina Budman | CEO and Principal Consultant, Leading Edge CDM Solutions


Gina Budman is a founder of LeCDMS (Leading Edge CDM Solutions), Clinical Data Advocates organization. As LeCDMS CEO and Principal Consultant, Gina ensures her teams – CDMs, Biostatisticians, Programmers and Validators – become trusted partners to their clients and deliver data of highest quality and compliance. She works with LeCDMS clients to establish project timelines, select proper technology solutions, and ensures client deliverables are met on time and per budget. In addition, Gina partners with various organizations building their internal CDM capabilities. Gina has over 20 years of Clinical Data Management experience, as well as 14 years of Project Management and Programming/technology. She worked as a Clinical Database designer, Manager of CDM, Director of CDM, and a data consultant for various industry leaders such as Boston Scientific, Abbott Vascular, and multiple CROs and Sponsors. Gina has created the first EDC course at UCSC Extension, and taught Data Management at various institutions. Using her extensive knowledge of the current technology, industry standards, processes, and principles of clinical data collection, Gina has successfully delivered quality data and led her Data teams through FDA and clients’audits. In addition, she loves what she does!


Moderated by Kunal Sampat | Senior Manager Clinical Programs, Abbott Vascular


Kunal Sampat is a Senior Manager Clinical Research at Abbott Vascular and also the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to help you accelerate your clinical research career and be a more effective leader. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning.



Have questions about Clinical Trials: What you need to know about Data Management? Contact Emanate Life Sciences

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When & Where

1501 Page Mill Road
Palo Alto, CA 94304

Wednesday, March 21, 2018 from 5:30 PM to 8:00 PM (PDT)

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Emanate Life Sciences

Emanate Life Sciences is a Bay Area staffing and consulting firm with extensive knowledge in the Life Sciences industry. We specialize in data management and software validation for midsize biotech and medical device companies.

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Clinical Trials: What you need to know about Data Management
Things to do in Palo Alto, CA Networking Science & Tech

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