吃瓜爆料

Pfizer: Changing TMF Operating Models for Simplicity and Connectivity

Pfizer shares how a new TMF operating model will enable simplicity and improve connectivity across the business and with sites. This includes practical tips for change management and examples of key processes to simplify.

Leila Canlas
Pfizer
TMF Operations Lead, Director

Emerging Biotech: Strengthening CRO Partnerships for TMF Quality and Efficiency

Apellis’ head of TMF shares lessons learned from current and former companies, including how to build an operating model on strong CRO partnerships and align processes and metrics for TMF teams of all sizes.

Steph Viscomi
Apellis Pharmaceuticals
Director, Clinical Documentation & TMF

Discussion: Understanding the CDISC TMF Reference Model Revision and Roadmap

CDISC shares how organizations can prepare for the latest revision of the TMF Reference Model, which aims to standardize and digitize the historical model. Discuss key takeaways from the revision, steps to prepare your organization, and what’s next on CDISC’s roadmap.

Paul Fenton
CDISC
Chair of TMF Reference Model Working Group and TMF Standards Subgroup, Member of TMF Reference Model Steering Committee

Jamie Toth
CDISC
Incoming Chair-Elect of the TMF Reference Model Working Group, Member of TMF Reference Model Steering Committee

Jason Methia
吃瓜爆料 Systems
Vice President, Clinical Operations Strategy

Discussion: Strategies to Improve Site Collaboration (Repeat Session)

More than 70% of total documents by volume in the TMF come from sites. Discuss strategies to improve site collaboration and TMF planning.

Frank Lin
吃瓜爆料 Systems
Director, Clinical Operations Strategy

Neha Ramani
吃瓜爆料 Systems
Manager, Customer Success, Clinical Operations

AbbVie: Driving Organizational Change with Strategic Partnerships

AbbVie shares the importance of TMF in leading organizational change. This includes how collaboration with study teams and sites and task distribution improve accuracy and completeness.

Renee Fate
AbbVie
Director, Clinical Records Management

Discussion: How Technology Can Help Make Data-Driven Decisions

Discuss with peers how to use technology to identify actionable insights from your data. 吃瓜爆料 will also share TMF trends across studies that can inform decision-making.

Jim Horstmann
吃瓜爆料 Systems
Senior Product Manager, 吃瓜爆料 eTMF

Neha Ramani
吃瓜爆料 Systems
Manager, Customer Success, Clinical Operations

Discussion: Strategies to Improve Site Collaboration (Repeat Session)

More than 70% of total documents by volume in the TMF come from sites. Discuss strategies to improve site collaboration and TMF planning.

Angela Faircloth
吃瓜爆料 Systems
Senior Director, Clinical Operations Strategy

Lauren Garson
吃瓜爆料 Systems
Senior Director, Clinical Operations Strategy

Biotech Panel: Unifying Clinical Processes and Teams with TMF

TMF experts from Biomea Fusion and Dren Bio share lessons learned about working cross-functionally and creatively solving challenges, all with lean teams and small budgets. Hear about their latest inspection experiences, methods of influencing users and stakeholders, and strategies for driving real-time TMF completeness.

Annette Bugno
Biomea Fusion
Associate Director, Clinical Records Management (TMF)

Ashley Sawaf
Dren Bio
Senior Manager, TMF Operations