IMPACT Clinical Trial Accelerator Program
IMPACT is a program for new ventures and startups in the life sciences or biomedical industries ready to do clinical trials
IMPACT: Integrated Management Platform to Accelerate Clinical Trials
IMPACT is a program for new ventures in the life sciences or biomedical industries who seek to commercialize their health-related inventions, conduct clinical trials, and secure regulatory approval.
The IMPACT Venture Navigators work with the venture to design, support, execute, and report on their clinical trials, including connecting the venture with a Principal Investigator.
Located at the Life Sciences Innovation Hub, IMPACT is supported by Innovate Calgary and offers unparalleled access to research space (office, wet and dry labs, prototype maker space), entrepreneurial and business development programming, mentorship, and connections to local experts, facilities and resources.
Impact is the recognized clinical trial vendor for the Creative Destruction Lab.
Work with the IMPACT Team to get your product to market
Housed within the Life Sciences Innovation Hub at the University of Calgary, in collaboration with Creative Destruction Lab - Rockies, and activated by Innovate Calgary, IMPACT facilitates the process of navigating the local research environment to ensure timely and smooth start-up, execution, and completion of clinical trials required to license and sell new medical devices, software, or pharmaceuticals in various domestic and international markets. Partnering with our team will result in a much faster and simplified research experience on the challenging path to commercialization of a medical device, drug, or other life science-based product.
Here’s what you can expect when you partner with the IMPACT Team to conduct your research:
- An initial consultation meeting to assess your company’s needs, expectations, and to map out a unique research plan
- A Navigator assigned to your project to act as a liaison between your company and the University and other important stakeholders
- Access to University and other local resources and connections
- Consistent guidance through all required processes and steps of start-up, execution, management, and close out of a clinical trial
TRACR: Enhanced Innovative Pre-market Regulatory Support
TRACR is the proprietary electronic regulatory document and application management system for IMPACT. It facilitates the process of compiling and submitting clinical trial approval requests for all classifications of drugs and devices to Health Canada or the FDA. The system links directly to clinical trial databases to facilitate automated adverse event and protocol deviation reporting to regulatory authorities and ethics boards while your clinical trial is conducted. IMPACT clients have access to TRACR as a complimentary service, or if needed, offered as a standalone tool for an annual fee.
Dr. Derek Exner, MD, MPH, FRCPC, FHRS
Medical Director, IMPACT
Canada Research Chair (Tier 1), Cardiovascular Clinical Trials
Professor and Associate Dean (Clinical Trials), Cumming School of Medicine
Dr. Exner is Canada Research Chair in Cardiovascular Clinical Trials, a Professor and an Associate Dean at the University of Calgary. Derek founded the IMPACT clinical trials program for medical ventures. He is a practicing cardiologist, heart rhythm specialist, and clinical trials expert. His clinical work and research focus on Cardiac Implantable Electrical Device (CIED) therapy. He has authored or co-authored over 300 articles, book chapters, and abstracts and has chaired and participated on multiple Guidelines Committees. Derek is actively engaged in several medical technology ventures, serving as the Chief Medical Officer of HelpWear Inc. and acting as an advisor to several other companies.
Karen Cowan, RN
Karen received her RN from Foothills Hospital School of Nursing and started her career working on a cardiology medical floor. She then worked in coronary intensive care for 10 years. During this time she also worked in the cardiac cath lab and cardiovascular intensive care unit. She then moved to the cardiac device clinic where she worked as a nurse clinician and research coordinator/manager with Dr. Exner for the last 20 years. Karen has extensive knowledge and expertise in clinical trials involving medical devices, including regulatory requirements and study coordination with new start-ups to large, experienced companies.
Michelle Nelson, PhD, CAPM
IMPACT Venture Navigator
Michelle received her Bachelor in Science (Human Kinetics) from the University of Guelph in 2010 and a PhD in Medical Science from the University of Calgary in 2015, specializing in translational research and clinical trials in nephrology. She is also formally certified in project management. Michelle is highly skilled in scientific writing, project management, and managing local clinical trials.
Caitlin Lambe, CCRP, BSc
As a Venture Navigator, Caitlin helps guide companies through the processes required to start, execute, and complete a clinical trial within the UCalgary environment. This includes linking ventures with clinical experts and opinion leaders, assisting with the development of a product and regulatory pathway, protocol development, and more. Caitlin brings over 10 years of operational and clinical trial project management experience to the team.
TRACR is the proprietary electronic regulatory document and application management system that facilitates the process of compiling and submitting clinical trial approval requests for all classifications of drugs and devices to Health Canada or the FDA. The system links directly to clinical trial databases to facilitate automated adverse event and protocol deviation reporting to regulatory authorities and ethics boards while your clinical trial is conducted.
TRACR provides a collective space to store and manage all documentation unique to each study.
IMPACT clients have access to TRACR as a complimentary service, or if needed, offered as a standalone tool for an annual fee.
Life Sciences Innovation Hub
3655 36 St NW
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