Medable SaMD Platform
A Medable SaMD Platform is a Software as a Medical Device that is available through the Medable DCT Platform that integrates medical devices to enhance clinical patients' health and treatment decision.
- Example(s):
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- Counter-Example(s):
- See: Clinical Trial, Decentralized Clinical Trial, Telemedicine, mHealth, eHealth, Telehealth, Health Care Service, SaaS, Direct-to-Patient Digital Trials Platform, End-to-End Clinical Research Platform, Electronic Clinical Outcome Assessment (eCOA) System, Electronic Patient-Reported outcome (ePRO) System, Cloud-based Digital Patient Recruitment and Engagement Platform, Siteless Clinical Trial.
References
2021
- (Medable, 2021) ⇒ https://www.medable.com/products/dct-overview Retrieved:2021-09-26.
- QUOTE: Compliance and Security at the Core
- Medable’s platform is secure, compliant, and scalable
- Built with the highest standards of data privacy and security
- Includes FDA 21 CFR Part 11, HIPAA, GDPR, and more.
- QUOTE: Compliance and Security at the Core
2018
- (Coravos, 2018) ⇒ Andrea Coravos (January 23, 2018). “Clinical trials are in need of a digital makeover". In: Digital Initiative - Harvard Business School.
- QUOTE: Going “fully-virtual” can be an operational challenge for biopharma. For example, if the protocol requires a participant to get regular chemo, having the infusions at home could be a risk (e.g., patient has anaphylactic shock and no medical support to treat it). As a result, many biopharma companies are taking a “direct-to-patient” approach when possible and may have some parts of the trial remain in a clinic while shifting more touch points to the home (e.g., more virtual).
There are a few business models that are starting to emerge. First are companies that are building a “Platform-as-a-Service". Medable, launched in 2013, is building a leading cloud-platform product that is designed for siteless trials and has a number of tools ready to deploy direct to patient. This model is a technology play, building products that are highly configurable and deployed across iOS, Android, and the web. Parallel6, which was recently acquired by PRA Health, is also building a software-based platform that Sponsors then license for their trials. ClinPal is building a cloud-based digital patient recruitment and engagement platform, currently focusing on “siteless” trials.
- QUOTE: Going “fully-virtual” can be an operational challenge for biopharma. For example, if the protocol requires a participant to get regular chemo, having the infusions at home could be a risk (e.g., patient has anaphylactic shock and no medical support to treat it). As a result, many biopharma companies are taking a “direct-to-patient” approach when possible and may have some parts of the trial remain in a clinic while shifting more touch points to the home (e.g., more virtual).