“I highly recommend the TRAQS program to any healthcare company that needs regulatory support. Students in the TRAQS program get to see the different activities that pharmaceutical companies do before finalizing a specific drug for further research and they get to apply what they have learned in the real world, solving regulatory problems for C-level executives. Students went above and beyond in their preparation for our projects, consistently asked insightful questions, participated in active discussions, and sought out additional resources to achieve goals.”
TRAQS projects are cooperative ventures with industry sponsors, designed to permit a small team of interdisciplinary students to work on projects defined by specific needs and objectives in collaboration with a corporate sponsor.
Why consider being a TRAQS partner or student?
The value proposition for sponsor companies reaches beyond enlisting quality talent to support company needs. For students, working with corporate sponsors provides a unique experiential opportunity to be involved with day-to-day projects, helping sponsors meet their goals.
- Presents the opportunity to expand operating bandwidth without investing in an additional permanent headcount.
- Students get the opportunity to work with a corporate liaison in a teamwork environment.
- Gives companies the ability to address a specific business opportunity or problem that may otherwise be relegated to a lower priority due to limited resources.
- Provides students and sponsors with skills as an emerging leader in managing a project and team.
- Working with enterprising graduate students in a semester-long project – and assessing them for possible future employment.
TRAQs projects consist of four to six graduate students who contribute approximately 1,000 hours to the effort over a single academic semester (a 15-week period). Upon project completion, students produce a project plan, confidential written final report, and confidential final presentation delivered at the sponsor site.
Projects can be structured around opportunities such as regulatory pathways, competitive intelligence, background information for clinical trial design, agency communication, marketing strategies, quality systems, and more.
Past Projects and Industry Sponsors
Accordion Content
- Competitive research and analysis for specified product development area (U.S. and international)
- Research/coordinate research for U.S. and global regulatory requirements
- Develop standardized processes, workflows and tools for data collection, entry and validation with the aim of developing an efficient repeatable process
- Research Health Authority websites for requirements and guidance
- Research and assessment of clinical trial requirements for new products and/or new indications (U.S. and International)
- Create Target Product Profile for new drug and/or biologic products
Assist with the assessment of existing documents and create templates for key documents using elements of best practice:
- Target Product Profile
- Gap Analysis
- Clinical Development Plan
- Regulatory Strategy
Participate in working sessions with Regulatory and Development Consulting experts
Work alongside sponsor team members to compile content for FDA and International submissions
- Assist with development of white papers
- Assist with development of slides for webinars
- Research and analyze pricing and reimbursement for new or modified drugs/biologics/medical devices