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As the world begins to relax restrictions, what are the lessons learned that can catapult us into the next innovation in trial operations for good?
In this webinar, our panel of experts share examples and lessons learned during the COVID-19 window and explore how those lessons can drive meaningful change over the next 12 months including:
- Leveraging technology to maximize risk and quality oversight
- Maximizing the patient experience and patient retention
- Designing trials to collect the data we need
- Managing missing data and redesigning analyses to account for anomalies like COVID
On-Demand Webinar Overview:
Title: Minimize Disruption of Your Oncology Trial
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Meet the Speakers:
Mara Holinger, PhD, RAC
Vice President of Regulatory Affairs, Veristat
Mara Holinger provides pharmaceutical, biotech and medical device firms with strategic consulting to prepare their regulatory pathway, design their clinical program and trials, perform gap analysis for CMC and preclinical reporting and write regulatory applications. Additionally, she is an expert in regulatory agency meeting preparation, moderation and logistical support, and services as an Authorized Regulatory Representative and US Agent. Mara has written, reviewed or provided oversight for more than 20 Investigational New Drug Applications (INDs), multiple Orphan Drug Designation (ODD) applications, breakthrough designation applications, special protocol assessments, fast track applications and several New Drug Applications, including 505(b)(2).
Sr. Clinical Data Manager, Veristat
Brendan has 20 years of global clinical data management experience in pharmaceuticals, biotechnologies, and global CRO organizations; participating in and leading data management teams with an emphasis on enhancing the performance and efficiency of database design, entry, documentation, review, reconciliation, and quality control. His expertise and experience ranges from study startup activities through database decommission while leading, overseeing, and training study team members from various departments on all processes related to database activities in multiple database systems.
VP Clinical Operations, OncoBay
Dannelle has over 20 years of global clinical development experience in pharmaceuticals, biotechnologies, and global CRO organizations leading clinical research teams with an emphasis on enhancing the performance and efficiency of oncology clinical research. Her expertise and experience ranges from clinical development planning and regulatory consulting to leading studies from first in human through FDA and EMA approval. For the past 13 years, she has held executive level positions focused on portfolio leadership, strategic leadership, and customer relationship development.
Director, Virtual Health, Moffitt Cancer Center
Cristina has over 20 years’ experience in providing leadership and strategic direction designing digital experiences. She currently serves as the Virtual Health Director for the Moffitt Cancer Center. Recently, Cristina lead the organization’s telemedicine efforts to rapidly respond to COVID, finding ways to protect immune compromised patients continued access to care. The quick pivot in platform and workflow enabled access for oncology patients and expanded the volume of visits by more than 5,000%. Cristina previously served as the Managing Director of Learning and Performance with the American Association of Physician Leadership (AAPL), devising performance-based learning for physician professional development. In addition, she has held leadership positions with the Florida Virtual School.
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