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ACDM19 Speaker Details

Maria Craze

Maria Craze

Merck Sharp & Dohme

Biography:

Maria Craze is currently the Executive Director and Head of Global Data Operations at Merck & Co., Inc. (aka MSD) in the US. She has 17 years’ experience in Pharmaceutical Clinical Data Management. That experience ranges from clinical data manager entry level tasks through study lead for study design, study conduct & lock as well as process expertise, project management leadership and people management. In her current role, Maria sits on the Global Data Management and Standards Leadership team and is fully accountable for a team of over 650 data management professionals in 5 countries supporting over 8 therapy areas and hundreds of clinical trials. Maria also was recently appointed to the Board of Trustees for the Society of Clinical Data Management (SCDM) and is an active member of the Drug Information Association (DIA) and American Society for Quality (ASQ) in addition to the ACDM. Maria holds a Master’s degree in Business Administration (MBA) complimented by a Bachelors in Exercise & Sports Medicine.


Title of Session: Improving Efficiency and Effectiveness in Clinical Data Management of Oncology Studies, a 4 1/2 pronged approach

Description of Session:

New indications, highly complex and adapting protocols, new health critical patient populations, collaborative studies, novel and specialty imaging, constant data locks and high demand driving speed of hiring, training and development of CDM all pose new challenges for Clinical Data Management (CDM) organizations with pressure and need to be more efficient and effective. There are particular challenges in; design of data collection and data validation tools, proper set up and management of numerous External Data types (imaging, biomarkers, biopsies, etc.); Efficient and quick training programs that ensure the data is reviewed with optimal quality and a proper balance between robustness vs. usability of data entry guidelines to meet the investigator sites’ expectations as a Sponsor.

Our team has implemented an enhanced 4 1/2 -pronged approach to meet the above challenges:

  1. Ensuring the CDM staff have:
    1. solid expertise in end to end clinical trial study development;
    2. advanced knowledge of oncologic diseases, patients, indications and trials;
    3. fully supportive and continuous mentoring and training programs

½: Improving the SDTM and CDISC knowledge and comprehension, its use and application throughout the study.

  1. Developing robust but flexible validation tools to enable team collaboration in design, consistency with the protocol, and quality from start to finish to support high quality filing and decision making deliverables while maintaining compliance.
  2. Engaging with sites to improve the sites’ experiences.
  3. Working to improve the acquisition and management of complex and high volume external data types

DM has ever been changed by the introduction of Oncology. We must be agile and innovative and keep continuously learning and seeking out improvements. Getting to a point where the critical data, supporting the efficacy and safety of the drugs, is cleaner faster with fewer resources and with optimal quality, will remain one of our top priorities.

Learning Objectives:

Understand MSD´s approaches to improving the efficiency and effectiveness of Data Management in Oncology Studies

Understand the main challenges faced by MSD in the Data management of Oncology studies

Learn how MSD is improving the Data management of its oncology studies

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