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It's Time to Elevate and Innovate - Reimagining Clinical Trial Execution

CONFERENCE PRESENTATION · SCDM 2024 EMEA Leadership Forum & Conference
It's Time to Elevate and Innovate - Reimagining Clinical Trial Execution
  • Session Type: Panel Discussion
  • Topic: Clinical Trial Operations
  • Session Level: Intermediate
Overview
Sites are drowning in sponsor and CRO provided technology. This session will be focused on hearing from sites about innovations that they are embracing to drive better efficiency, quality and more effective use of capital. Further, its time to move traditional DM functions of redundant data review to providing data science and oversight which complements the team and drives further innovation. Finally, what are regulators doing to elevate and innovate to help reimagine clinical trial execution. This session will provide the site, data science and regulatory perspective on actions that can be taken to elevate and innovate.
What You'll Learn
  • Assess the varying roles that sites can play in driving better quality, efficiency and more effective use of capital
  • Translate techniques for implementing and driving the move from data management to data science and oversight to your organization
  • Formulate an internal approach based on current regulatory expectations and how that can be applied to innovating in clinical trial execution

Meet the Presenters
Jonathan Andrus
President & COO
CRIO
Jonathan leads CRIO’s customer experience, engineering, product management, quality management and sales and marketing teams. With over 27 years of experience in operations, data management, quality and commercial operations, Jonathan brings a wealth of real-world experience. An active thought leader, blogger and presenter, Jonathan serves on the board and executive committee of the Society for Clinical Data Management (SCDM) and has been on the advisory boards of CDISC and DIA. Jonathan is co-lead with the Decentralized Trials and Research Alliance (DTRA) workstream initiative and a co-author on upcoming eCOA Consortium publications.
Richard Young
VP, Strategy, Clinical Data
Veeva Systems
A veteran of almost 30-years in life sciences, Richard is Vice President, Strategy, Clinical Data. Richard is responsible for defining strategy and direction for Veeva's Clinical Data applications, especially with respect to site and patient generated data. Richard brings Veeva customers both keen executive vision and proven operational experience in data management, eClinical Solutions, and advanced clinical strategies (e.g. adaptive trials, risk based monitoring, strategic technology reviews).

Richard’s extensive background in clinical data management, operational excellence, strategic planning, marketing, and business development enable him to provide fresh insights to clinical strategies.
Agnieszka Gackowska
VP, Clinical Operations & Country Head Poland
VELOCITY CLINICAL RESEARCH
Dr Agnieszka Gackowska graduated from the Medical University of Warsaw with a diploma of Doctor of Medicine and has over 26 years of experience in the pharmaceutical industry.
Since January 2024 she has been associated with the largest research site network, Velocvity, where she is responsible for clinical operations at sites in Poland and growth and development of the company. Before she joined Velocity she led the Global Site Solutions Team at Parexel. CRO with the mission of partnering with research institutions at a strategic level to make clinical trials accessible to every patient and easier to manage for investigative teams.
In addition to this role, she also led Parexel Clinical Feasibility and Site Intelligence Teams.
Before joining Parexel, Dr Gackowska served as the Head of the Patient & Site Networks Department in CEE & ME for IQVIA and worked in big pharmaceutical companies, such as GSK and Novo Nordisk on various managing positions in the Marketing and Sales departments.
In addition to her regular job, Dr Gackowska collected her expertise as a non-profit Managing Director of the Hemophilia Foundation in Poland.
Throughout her career, she has been involved in the development of educational programs in the field of preventive medicine, vaccines, modern treatments and clinical trials, both for the medical community (doctors and nurses) and patients. She was also the creator of the program and a lecturer at postgraduate studies in the field of clinical trials conducted by the Medical University of Gdańsk, the Medical University of Lublin and the John Paul II Catholic University in Lublin.
Currently, she actively cooperates as a member with the following societies: SCRS, GCSA IAOCR and GCP.pl
Marc Wartenberger
Sr. Director, Security, Corporate QA & Compliance
CRIO
As the Sr. Director of Security, Corporate QA and Compliance, Marc is leading the corporate security, quality and compliance initiatives at CRIO. Additionally, he’s serving as CRIO’s Data Protection Officer. Prior to CRIO, Marc was leading the Quality Assurance efforts at snapIoT, now part of Labcorp Drug Development. Before snapIoT, Marc was a key member of the Corporate Compliance and QA group at Clinical Ink from 2012-2021 and served as its Data Protection Officer from 2018 to 2021.

He is a frequent contributor in the regulatory and compliance space and has participated as a speaker and panelist host at the following:

SCDM India Annual Conference SCDM Annual Conference Society for Clinical Research Sites (SCRS) Global Site Solutions Summit Association for Clinical Research Professionals (ACRP) Annual Conference
Earn CEUs
SCDM is authorized by IACET to offer 0.1 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.

Price
SCDM members: $50
Non-members: $175

Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.
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