The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Developing oncology compounds is a constantly evolving process, and with the dramatic rise in costs, and competitive trials, making every step count is now more critical than ever. At the clinical trial stage conducting oncology clinical research in Canada is an option that provides real opportunity for U.S. biotechs.
The most important thing to do?
When considering a trial expansion to Canada the most important thing to do is to include Canada early in your drug development planning!
Why is this the most important ?
Including Canada early on in the drug development process helps ensure things fall into place more effectively for your oncology clinical trial because it results in higher Site engagement and performance.
How does this make a difference?
Building relationships with key Sites early on will contribute to the success of your program.
Being part of a compound’s development from the start will allow oncologists and their research teams to develop an in-depth understanding of the study design, procedures, and drug safety profile.
Study participant screening strategies and practices will be identified early on, and attracting the targeted patient population will be facilitated.
Oncologists will also provide valuable insight specific to the Canadian study participant population and competing therapies, so as to develop an optimal commercialization plan for the region.
Scimega is a specialized CRO skilled in collaborative vendor teaming with 20 years unparalleled Canadian oncology experience, 100+ successful oncology clinical trials – never rescued by another CRO.
Our clients develop cutting-edge oncology therapies and trust our results: overall SDV of 84.5% across all enrolling sites; 93% on-time delivery of site reports throughout 2018; and site start-up 50% quicker than the industry average.
Are you considering expanding to another region? Our business model effectively supports US biotechs making this move. In record time, our proven feasibility assessment approach connects Sponsors with our extensive network of top performing Canadian oncology Investigators.
Contributed by: Julie Martin, Director, Clinical Operations