Product
This is a very unique value proposition for both our ePRO ad EDC.
What is our EDC and ePRO integrate with one another?
This is a branch of pharmacology concerned with the movement of drugs within the body.
What is pharmacokinetics (PK)?
EU regulation on data protection and privacy
What is GDPR?
If you are looking to sell ePRO, don't even bother with this therapeutic area.
What is asthma or respiratory?
The overly-complex EDC industry leader
What is Medidata?
This feature of our eCRF build enables the answer to one question to determine whether or not a subsequent question is displayed.
What is skip logic?
A study that assesses preexisting data to look for different outcomes.
What is a retrospective study?
This law relates the device in question to a device previously approved for market.
What is 510(k)?
This is a type of eCOA that is from the perspective of a parent, spouse, non-clinical caregiver.
What is observer-reported outcome (ObsRO)?
As we close out the 2010s decade, we must acknowledge that THIS QUEEN had 9 Billboard Hot 100 #1s this decade, most of any artist, and founded three revolutionary companies (a makeup brand, a lingerie brand and a high fashion brand). Hint: not Taylor Swift
Who is Rihanna?
eConsent utilizes multimedia and quiz to maximize patient comprehension and reduce THIS.
What is patient attrition?
A device study in unhealthy humans that is the last step before approval.
What is a pivotal study?
Under the new EU MDR, many Class 1 devices that are currently on the market are now classified as THIS.
What are Class 2A devices?
These 3 value props explain why it is advantageous to utilize Medrio ePRO. (100 points each)
What are EDC/ePRO integration, click-to-configure interface, easy to create localized screenshots, 7-week ePRO-build timeline, data accuracy, or real-time review of data?
A data-recording system that is deceptively cheap, contains no edit checks, no reporting, and comes with storage costs and transportation costs.
What is paper?
Medrio DDC significantly reduces THIS by directly inputting query-approved data into the EDC.
What is source data verification?
A study that is initiated at a site or university by a principle investigator with permission of a sponsor to test for a different indication.
What is an investigator initiated study?
The U.S. requirement that sponsors, CROs and other FDA-regulated industries implement controls, including audits, system validations, audit trails, and electronic signatures.
What is Title 21 CFR Part 11?
These 2 therapeutic areas are low effort / high impact opportunities for ePRO. (200 points each)
What are vaccine studies, oncology, medical device, post-marketing studies, and gastrointestinal?
This EDC company focuses on early phase studies but has two-year contracts to accommodate for its rumored year-long study build.
What is Omnicomm?
This is Medrio's most recent module!
What is Local Labs?
Before pre-clinical testing, this testing happens in petri dishes.
What is In Vitro Testing?
If affected by MDR, a company should first take this step.
What is update technical documentation (including QMS, clinical evaulation, post-market surveilence)?
THIS is how many ePRO customers Medrio has and THIS is how many ePRO studies Medrio has done. (250 each)
What is 65 customers and 300 studies?
Cheap, open-source EDC that lacks compliance and effective reporting
What is Openclinica?