Written and maintained by CASRAI Editorial Board
Last updated
Disclaimer: This guide is prepared for informational, research administration, and trial operational purposes only and does not constitute medical advice or clinical care instructions.
Short answer
Medable is a modular, cloud-based eClinical software platform engineered for decentralized clinical trials (DCTs) and hybrid clinical studies. It digitizes protocol workflows—including electronic informed consent (eConsent), electronic clinical outcome assessments (eCOA/ePRO), and remote video visits—while enforcing U.S. Food and Drug Administration (FDA) 21 CFR Part 11 compliance and Good Clinical Practice (GCP) data integrity standards.
Definition and scope
Medable is an enterprise Software-as-a-Service (SaaS) platform built to operationalize decentralized, hybrid, and digitally enabled clinical research. In traditional trial models, protocol execution is strictly site-centric: participants visit physical clinics for screening, paper consent signing, drug dispensation, symptom recording, and monitoring. Medable decentralizes these workflows through mobile apps, web portals, and connected device interfaces that capture regulatory-grade data remotely.
The operational scope covers four core user groups across the research enterprise:
- Sponsors and CROs: Teams at pharmaceutical sponsors and contract research organizations (CROs) deploy Medable to configure digital protocols, manage participant cohorts, and aggregate trial data.
- Site Investigators and Coordinators: Clinical research coordinators (CRCs) and investigators access dashboards to track milestones, conduct telemedicine evaluations, and countersign consents.
- Study Participants: Patients and caregivers use unified apps to review protocol materials, sign consent forms, log daily outcomes, and attend visits.
- Local Healthcare Providers: Community clinics and phlebotomy labs coordinate localized testing without full investigator site infrastructure.
This model aligns with the FDA Guidance for Industry, Conducting Clinical Trials With Decentralized Elements (published September 2024, Docket No. FDA-2022-D-2870). The FDA confirmed that decentralized elements exist on a spectrum, requiring identical GCP standards and participant protections across all settings.
How it works or how it is used in practice
Medable functions as an integrated eClinical architecture connecting participants, trial sites, and sponsors to a validated cloud repository governed by automated audit logging.
1. Electronic Informed Consent (eConsent)
Medable eConsent replaces standard paper forms with multimedia-guided onboarding. Participants review protocol summaries supported by educational videos and glossary tooltips. The platform embeds mandatory comprehension checks before signature capture. Identity verification confirms participant identity, after which participants and investigators execute digital signatures conforming to FDA 21 CFR Part 11 Subpart C (§ 11.50 and § 11.70). For protocol amendments, Medable automates version tracking and prompts participants for re-consent.
2. Electronic Clinical Outcome Assessments (eCOA+) and ePRO
The eCOA+ engine captures Patient-Reported Outcomes (ePRO), Observer-Reported Outcomes (ObsRO), and Clinician-Reported Outcomes (ClinRO). To prevent retrospective backfilling—where patients complete paper diary entries from memory before site visits—Medable enforces time-locked entry windows. Data entries receive automated UTC timestamps, upholding ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, and Accurate).
3. TeleVisits and Digital Health Technologies
For remote clinician check-ins, Medable provides integrated, HIPAA-compliant video consultations within the study record. The platform also ingests continuous digital biomarker data from validated medical devices and digital health technologies (DHTs)—such as spirometers, glucose monitors, and wearable sensors.
4. System Interoperability
Medable connects with clinical research infrastructure via secure REST APIs and webhooks, transferring data bidirectionally between Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT/RTSM), and electronic Trial Master Files such as Veeva Vault.
Types or related concepts
The following table contrasts Medable modular decentralized trial workflows with traditional site-centric execution, sourced to FDA 21 CFR Part 11, the FDA September 2024 Decentralized Elements Guidance, and Medable platform specifications.
| Trial Domain | Traditional Site Model | Medable Modular DCT Model | Regulatory Basis |
|---|---|---|---|
| Consent | In-person paper signing; physical binder storage; manual re-consent tracking. | Multimedia eConsent; interactive comprehension checks; 21 CFR Part 11 digital signatures. | 21 CFR 50.20, 21 CFR 56.109, and 21 CFR Part 11 Subpart C. |
| Outcome Assessments | Paper diaries; high risk of retrospective backfilling; manual transcription into EDC. | Native mobile eCOA/ePRO; time-locked entry windows; direct cloud data ingestion. | ALCOA+ data integrity; FDA September 2024 Guidance § V. |
| Monitoring | Mandatory in-person clinic visits; participant travel burdens and geographic limits. | HIPAA-compliant TeleVisits paired with scheduled site visits; remote DHT sensor capture. | FDA September 2024 Guidance § III.B; ICH GCP E6(R2) § 5.18. |
| Audit Trails | Paper correction lines with date/initials; fragmented clinic database logs. | Automated, time-stamped audit trails recording entry, edit, user ID, and reason (§ 11.10(e)). | 21 CFR 11.10(e); FDA Data Integrity Guidance (2018). |
| Oversight | Direct physical clinic observation; localized paper delegation logs. | Centralized digital dashboard; automated protocol deviation flags; real-time adherence analytics. | 21 CFR 312.60; FDA September 2024 Guidance § IV. |
Where it matters for labs, clinics or supply decisions
Deploying Medable directly impacts operational logistics for laboratory managers, clinical coordinators, and supply chain teams:
- Direct-to-Participant Supply Logistics: Decentralized studies ship investigational medicinal products (IMPs) and collection kits directly to participant homes. Medable tracks delivery confirmations, participant receipts, and temperature indicators, coordinating with IRT systems.
- Local Laboratory Specimen Workflows: Rather than requiring travel to central research sites, decentralized trials leverage community phlebotomy labs. Medable supports requisition tracking and chain-of-custody logging to map local specimen collection back to the protocol.
- Site Administrative Workflows: While participant travel decreases, site staff manage digital queries, monitor sensor connectivity, and review compliance alerts. Direct API integrations between Medable and EDC databases eliminate redundant dual-entry transcription.
- Routine Local Healthcare Providers: The FDA September 2024 Guidance clarified that licensed community healthcare providers performing routine services within standard medical practice do not require detailed task logs or Form FDA 1572 filings.
Common misunderstandings
Common misconceptions about Medable and decentralized trial platforms include:
- Decentralized trials eliminate research sites entirely: Most trials follow hybrid models. Physical sites remain essential for complex diagnostic procedures, imaging, and primary infusions, while Medable handles routine follow-ups and ePRO capture. Principal investigators maintain regulatory accountability.
- Regulatory standards are relaxed for remote trials: Regulatory expectations for data integrity and participant safety remain identical to traditional studies. Remote eClinical systems must satisfy 21 CFR Part 11 validation (§ 11.10(a)) and audit trail requirements (§ 11.10(e)).
- eConsent is merely an electronic PDF scan: Compliant eConsent requires an interactive digital workflow featuring verified identity checks, comprehension evaluation tools, dynamic version management, and legally binding digital signatures.
- Standard consumer apps meet trial requirements: Consumer software lacks GxP validation. Enterprise DCT platforms operate under audited SOC 2 Type II controls, AES-256 encryption at rest, TLS 1.2+ encryption in transit, and HIPAA/GDPR privacy protections.
Frequently asked questions
What is Medable used for in clinical research?
Medable is used by sponsors, CROs, and sites to execute decentralized and hybrid clinical trials. Its modular software suite supports electronic informed consent (eConsent), electronic clinical outcome assessments (eCOA/ePRO), telehealth consultations, and connected sensor data ingestion.
How does Medable ensure compliance with FDA 21 CFR Part 11?
Medable satisfies 21 CFR Part 11 through computer system validation (§ 11.10(a)), automated time-stamped audit trails recording all entries and edits (§ 11.10(e)), role-based authority checks (§ 11.10(d)), and secure electronic signatures permanently linked to records (§ 11.50 and § 11.70).
What is the difference between ePRO and eCOA on the Medable platform?
Patient-Reported Outcomes (ePRO) are a subset of Clinical Outcome Assessments (eCOA). ePRO captures data reported directly by participants without clinical interpretation, whereas eCOA also encompasses Clinician-Reported Outcomes (ClinRO) and Observer-Reported Outcomes (ObsRO).
Does Medable integrate with existing Electronic Data Capture (EDC) systems?
Yes. Medable offers validated REST APIs and webhooks that enable bidirectional data exchange with leading Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and electronic Trial Master Files like Veeva Vault.
What are investigator oversight duties in decentralized trials?
Under 21 CFR 312.60 and the FDA September 2024 Guidance, the principal investigator retains ultimate responsibility for trial conduct, participant safety, and data integrity, regardless of whether assessments occur on-site or through decentralized platforms.
Sources
- U.S. Food and Drug Administration (FDA). Guidance for Industry: Conducting Clinical Trials With Decentralized Elements (Docket No. FDA-2022-D-2870, 89 FR 76470, published September 2024). Accessed November 8, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements
- Medable Inc. Platform Architecture and Product Specifications (eConsent, eCOA+, TeleVisit, Studio). Accessed November 8, 2026. https://www.medable.com/platform
- U.S. Code of Federal Regulations. Title 21, Part 11: Electronic Records; Electronic Signatures (21 CFR Part 11). Accessed November 8, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
- American Institute of Certified Public Accountants (AICPA). SOC 2 — SOC for Service Organizations: Trust Services Criteria. Accessed November 8, 2026. https://www.aicpa-cima.com/topic/audit-assurance/audit-and-assurance-greater-than-soc-2
- International Council for Harmonisation (ICH). Guideline for Good Clinical Practice E6(R2) / E6(R3). Accessed November 8, 2026. https://www.ich.org/page/efficacy-guidelines
