Medable Decentralized Clinical Trial (DCT) Platform
A Medable Decentralized Clinical Trial (DCT) Platform is a DCT SaaS that is provided by Medable Incorporated.
- Context:
- Website: https://www.medable.com/products/dct-overview
- It based on a global multi-tenant cloud infrastructure.
- It provides high data availability, redundancy, recoverability.
- It designed for 24/7 performance, security monitoring, global privacy, and security compliance.
- It can include sub-systems, such as:
- …
- Example(s):
- Medable Digital & DCT Screening Platform,
- Medable SaMD Platform - it integrates device to enhance clinical patients' health and treatment decisions,
- Medable eConsent,
- Medable eCOA,
- Medable TeleVisit,
- Medable Remote Patient Monitoring System,
- Medable BioStat & Data Science Platform,
- …
- 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).