Oncology trials always come with their share of complexities and challenges. Since its onset, COVID-19 has had the industry’s undivided attention, with clinical trial professionals adapting clinical trial operational plans to accommodate. From data integrity to participant recruitment and retention, our industry has temporarily reconsidered long-held habits. 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
Cristina Naso, 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.
Dannelle Palmer, VP Clinical Operations, OncoBay
Dannelle Palmer 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.
Mara Holinger, PhD, RAC, VP 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. Holinger 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).
Brendan Merrick, 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.
Who Should Attend?
- Clinical affairs professionals
- Medical affairs professionals
- R&D Heads
- Oncology clinical professionals
- Oncology-focused biotech and pharmaceutical companies
- Clinical trial coordinators and site Managers
What You Will Learn
- An overview of the current Module V of the GVP
- Changes resulting from Revision 2
- Practical applications of Module V through case studies
Veristat is a scientifically oriented and impactful full-service clinical research organization (CRO) that is committed to partnering with emerging and small to mid-sized biotechnology firms to advance their therapies throughout the entire clinical development and regulatory submission process. Our team helps growing clients solve the unique and complex challenges that arise when trying to accelerate therapies along the development pathway to successful regulatory approval, beginning with regulatory planning, study design, protocol development, site selection and start-up through to patient recruitment, clinical monitoring, data collection, analysis and reporting. Ultimately, we guide our clients to market success so that their therapies become available to improve and save people’s lives. Our impact is proven by our regulatory track record of success — in 2018, Veristat supported 12 percent of all NMEs approval by the FDA.