IMPACT Clinical Trial Accelerator Program
IMPACT disrupts traditional healthcare innovation by accelerating marketing approval via a tailored evidence collection and regulatory framework.
IMPACT: Integrated Management Platform to Accelerate Clinical Trials
IMPACT is a program for new ventures in the life sciences or biomedical industries who are seeking guidance in conducting clinical trials to secure regulatory approval for their new health-related inventions.
The IMPACT Venture Navigators work with the venture to design, support, execute, and report on their pre-market clinical trials.
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.
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. We provide the expertise in the following areas and apply it in a streamlined framework to accelerate clinical trial timelines:
- Innovative regulatory and quality management system software
- Clinical research strategy
- Regulatory strategy (Health Canada, FDA, Europe)
- Protocol development
- Methodological support & data management
- Trial set up and management
- Knowledge translation
Tailored Regulatory, Auditing, Compliance and Reporting (TRACr) Software: Enhanced Innovative Pre-market Regulatory and Quality Management Support
TRACr is IMPACT’s proprietary electronic regulatory management which also supports an integrated quality management support tool (Enzyme). 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 and also includes quality management system modules relevant to new ventures (risk management, training, etc.).
Meet the Team
Dr. Derek Exner, MD, MPH, FRCPC, FHRS
Executive Director, Professor, Associated Dean of Clinical Trials
Canada Research Chair (Tier 1) of Cardiovascular Clinical Trials, University of Calgary
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.
Michelle Nelson, PhD, CAPM
Senior Manager, Strategic Planning and Business Development
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 certified in project management (CAPM) from the Project Management Institute. Michelle is highly skilled in scientific writing, project management, and managing local clinical trials and coordinates the ongoing development of the IMPACT program as a top tier solution for new ventures experiencing roadblocks in conducting pre-market clinical trials.
Karen Cowan, RN
Karen is a registered nurse who has worked the majority of her career with cardiac patients through all steps of their hospitalization including critical care / step down areas and diagnostic/clinical areas. She has over 20 years experience of research with Industry sponsored trials (small start-ups to large corporations), Investigator initiated trials and core lab management for International trials, in both the drug and device space. She brings her knowledge of the entire life span of the clinical trial process, database design, the University Ecosystem and Alberta Health Services environment to her role as a Venture Navigator in the development and ongoing growth of IMPACT and the TRACr software program.