How can smaller companies efficiently execute an audit-ready electronic Trial Master File (eTMF) with a small yet nimble ‘lean’ team? In this webinar, the featured speaker examines how this niche Canadian oncology CRO, deployed Connect eTMF from set-up to document upload, to QC, to audit preparedness with accuracy and speed.
Register for this webinar to learn more about how to:
- Understand the ‘lean team’ approach for a smaller organization to implement eTMF
- Maximize the eTMF utility within the context of a lean clinical team
- Identify background processes needed to start-up eTMFs and train users
- Maintain the eTMF as audit-ready through intelligent use of available QC processes
Bonus Offer: Register now and receive immediate access to the white paper Expert Guidance to Key Advantages of Canadian Regulatory Landscape.
Speaker
Patrick Smith, MSc, Clinical Trial Leader, Scimega Research
As a Clinical Trial Leader at Scimega, Patrick leads the eTMF initiative with a ‘lean team’ approach. In addition, his leadership ensures that his operations team of oncology clinical research professionals provides 50 percent quicker site start-up times for these cutting-edge oncology trials in Canada. With 15 years of clinical research experience — including his work with the Canadian Cancer Trials Group (CCG) and with some large CROs — Patrick’s focus areas are lung cancers, GI and brain tumor types as well as hematological malignancies. He received his Master of Science in Pathology and Molecular Medicine from Queen’s University, where he studied synthetic modifications to OC medications in osteoarthritis for the regeneration of cartilage. Patrick is a member of the American Society of Clinical Oncology (ASCO).
Message PresenterWho Should Attend?
Clinical operations team leaders from small to mid-size biotech and biopharma companies managing complex oncology clinical studies. Relevant job titles include:
- Manager/Associate/Assistant Director
- Director/Head/Vice President Operations
- CEO
- CMO
What You Will Learn
Attendees will gain insights into:
- A lean team approach to electronic Trial Master File (eTMF) implementation
- How to maximize eTMF utility with a small team
- Background processes needed to start-up eTMFs and train users
- eTMF audit-ready QC processes
Xtalks Partner
Scimega
Scimega is a niche Canadian oncology CRO acting in Canada for the conduct of global cutting-edge oncology trials sponsored by small to mid-size biotechs.
In the face of an ever-changing clinical trial landscape our robust operations design guarantees sponsors the quickest global site start-up and fastest patient recruitment with assured premium quality data.
Skilled in collaborative vendor teaming, our oncology experts work with your team to devise innovative solutions specific to the unique challenges of your oncology clinical trial.
25 years of unparalleled Canadian oncology experience means our operational KPIs consistently surpass global industry norms.
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