Regulatory

Pathway

Launching a medical device product can face many market access barriers that can complicate and frustrate efforts to beat your competitors to the punch and get new solutions to patients. With IMPACT’s regulatory expertise and proprietary software, we can ease that burden.

Regulatory

Pathway

TRACCR, Tailored Regulatory, Audit, Compliance and Clinical Reporting tool (TRACCR; pronounced [trækə(r)]), is IMPACT’s proprietary software platform designed to assist ventures with the regulatory planning and requirements associated with clinical trials and market approval of their products. TRACCR keeps track of the location of all investigational products, including whether the device is in use, involved in a patient adverse event or on route to a trial site or back to the sponsor.

TRACr

TM

TRACr, the Tailored Regulatory, Audit, Compliance, and Reporting tool, is IMPACT’s proprietary software platform designed to assist ventures with the regulatory planning and requirements associated with clinical trials and market approval of their products. TRACr keeps track of the location of all investigational products, including whether the device is in use, involved in a patient adverse event or on route to a trial site or back to the sponsor.

TRACCR

Our pioneering TRACr™ market access software helps medical device and biotech companies manage their regulatory journey and negotiate market access hurdles more quickly, intelligently and effectively, so that years of planning do not end up with launches caught in limbo.

Automate Workflows

TRACr automates workflows, tracks and manages records, and satisfies the submission requirements of the US FDA and Health Canada.

Compilation of Regulatory Applications

TRACr facilitates and accelerates the process of compiling the required information, data, and documentation to submit a clinical trial application to Health Canada or the FDA for medical devices and drugs of any classification.

Tracks and Manages Records

The tool enables ventures to reduce their human capital and ensures that nothing gets missed, making it a valuable addition to the regulatory services provided by IMPACT.

Trial Master File

TRACr automates workflows, tracks and manages records, and satisfies the submission requirements of the US FDA and Health Canada.

Adverse Event Reporting

TRACr links to clinical trial databases within RedCap and facilitates the automation of adverse event reporting, ability for editing for CAPA and root cause analysis and appropriate notification for regulatory authorities in real-time.

Device Tracking Log & SOP Pack

TRACr automatically tracks the delivery of investigational devices and drug products to trial sites. We also provide startups with templated SOPs to speed up the integration phase and lower costs.

Regulatory

Pathway

Regulatory

Pathway

TRACr

TM

TRACCR

Automate Workflows

Compilation of Regulatory Applications

Tracks and Manages Records

Trial Master File

Adverse Event Reporting

Device Tracking Log & SOP Pack

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