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.

IMPACT at UCalgary

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.

Venture Navigator Service

Services Offered

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

Clients

Zenna logo
optimi logo
Pionear technologies logo
Reach logo
Nanotess Logo
TRACR

TRACr

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

Derek Exner

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

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

Karen Cowan, RN

Venture Navigator

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.

Caitlin Lambe

Caitlin Lambe, CCRP, BSc

Venture Navigator

Caitlin received her BSc (Biology) from the University of Victoria in 2008 and has been working in clinical research in Calgary ever since. She is an enthusiastic and passionate Certified Clinical Research Professional (CCRP) with over 11 years of operational and clinical trial project management experience with various groups in the Cumming School of Medicine (CSM) at UCalgary. Caitlin's experience and skills include: delivery of multiple concurrent health research projects across various technical platforms and tools; including large scale clinical trials in stroke, custom projects and REDCap research projects; healthcare research project execution; clinical trial EDC database design, implementation, & data quality management; forming and maintaining strategic collaborations; identifying challenges and solutions to ensure investigators have the support they need to succeed in the clinical trials process. She provides a deep understanding of how clinical research and technical tools are interwoven to support health research and clinical trial projects.

Consultants

John Simon, BSc, RAC , CQA, RQAP-GLP, Regulatory Consultant

Marvin Cervantes, Regulatory Consultant

Rollin Brant, Statistical and Methodological Consultant

UCalgary Campus Aerial

Moving Solution-Driven Inventions Forward

Partnerships with University of Calgary’s IMPACT Clinical Trials Accelerator move health innovations forward, from concept to marketplace.

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Creative Destruction Lab is recognized as the commercial partner for the IMPACT program.