0 BSIC inittowinit

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Working Notes and Easter Eggs

**Value Proposition(s) ** TK to be moved to Main Readme @ launch

1. Potential to obtain a CPIM with the FDA

2. Alternative or combination option of COA tool pathway.COA info .

3. Position Blockchain-based Technology in a position to make a substantial positive impact at the December 18, 2017, meeting "Patient focused drug development" Meeting Information

4. Success of one or more of the 3 above items is a major step towards opening the funding flood gates for project above and beyond the scope of TrialPhi. Page 13 here for example

And a few more channels:

• Small Innovation Research Program
• Small Business Technology Program
• Grants & Funding Opportunities at NIH

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From page 2 of 6 FDA CPIM INFO DOC. Potential outcomes of CPIMs include efforts leading to:

• Regulatory submissions of clinical trials with new designs and methods
• Proposals for the use of emerging technologies
• Proposals for biomarker qualification or the use of biomarkers in regulatory submissions
• Natural history studies
• Public workshops and future collaboration of FDA with external parties
• Development of new guidance
• Formation of new consortia and public-private partnerships to advance regulatory science efforts

MVP Functions: Tracking of De-identified Patient Data for 2 Key Metrics. 1 is a MAJOR pain point to all parties involved and the other is patient reported outcomes via Quality of Life Survey.

Concomitant Medications (Con-Meds) - Medications taken by the patient before during and after study going back sometimes 5 to 10 years.

• Data fields for interface: ID, Name, Description, Dosage, Frequency, Start Date, Stop Date, Notes.
• QOL Survey - ID, Date, Time, Note, Field 1, Field 2, ...., Field 5. -as simple as it seems .

Lots of refinement still to happen in the next 18 hours but wanted to get this pushed out there for digestion and any and all feedback.

Tear it apart

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