Decentralized Clinical Trial Solutions

Patient Recruitment

Cloudbyz DCT solution facilitates end-to-end virtual patient recruitment globally. We deliver capability in study listing, patient portal, pre-screening, participant interest form templates, appointment scheduling, campaign management, etc.

Recruitment Campaign

Cloudbyz facilitates virtual recruitment campaigns with pre-screening, patient education, referral management, mass email and SMS capabilities, customized and pre-built templates, etc. Analytical features support campaign metric calculations for rational decision making.

Pre-Screen

Cloudbyz product features are designed to support pre-screening for patient recruitment includes questionnaires and information for volunteership eligibility and are customizable as per study. It also supports digital/virtual patient recruitment.

Investigator Recruitment

Cloudbyz investigator recruitment, a pioneer in this functionality, enables investigators to gain easy access to feasibility study of any existing/potential site with regards to clinical trials. We facilitate mass email distribution (using the investigator database) targeted to different investigators with accessible site feasibility links.

Study Website & Documents

Cloudbyz study website enables centralized creation of a new study website with specific web pages, landing pages, self-assessment tools and patient registration. It also does not require additional hosting.

eConsent

Cloudbyz eConsent solution enables real-time document management of informed patient consent and e-signature with multi-gadget configurability. It includes template-based and interactive multimedia approaches to expand the scope of eligibility testing.

Study, Site & Project Management in CTMS

Cloudbyz enables comprehensive study, site and end-to-end project management of the clinical trials through its different CTMS modules. It delivers complete off-site and hybrid-based process streamlining including site feasibility study, report monitoring, study management, IRB approval tracking, training, real-time performance tracking, among others.

Virtual Visit / Telemedicine

Cloudbyz supports virtual visits for investigators/CRO and patients by generating visit appointments as per the schedules and maintaining schedule calendar. Telemedicine functionality is used for routine follow-ups to identify adverse events. It also helps in setting up procedures, subject visits and payment policies depending upon the budgets and study protocols.

Study Budget & Payments

Cloudbyz DCT budget solutions enable a hawk-eye budget estimation, planning, payments management across clinical trials. Cloudbyz delivers defined budget templates, real-time tracking of investigator grants, procedures and visit payments along with budget projections and variance between planned and realized expenses.

ePRO / eDiary

Cloudbyz ePRO delivers multi-media enabled and template-driven patient reported outcomes on mobile devices. These reports are patient-centric and API-enabled with real-time data visibility through interactive dashboards and data visualization reports.

Patient Health Data

Cloudbyz decentralized clinical trial solution enables capturing patient data electronically both from wearables and manually entered information by investigators. Patient health data (like heart beat, SpO2,etc) from multiple gadgets, on a real-time basis are extracted through integrations. Also other data like medical history can be updated and rolled-up post manual feed on the participant portal.

Mobile and Health Device Data Capture

Cloudbyz decentralized clinical trial solutions enable extraction of mobile and health device data through integration with these third party applications and devices through APIs.

eTMF / eRegulatory

Cloudbyz eTMF software delivers 21 CFR Part 11 compliant digitized trial master files with a centralised site level and study level folder structure and defined folder approval process. It also enables zip folder TMF downloads for easy submissions during FDA approvals.

Investigational Products & Study Supply Management

The Cloudbyz DCT module ‘IP accountability’ enables real-time tracking of investigational products throughout the supply chain i.e. starting from sponsor/CRO to the site and vice-versa.

EDC / eSource

Cloudbyz solution offers electronic data capture (EDC), with product features for source data validation (SDV), questionnaire templates, queries and eSignature and transcribes them into systems. It facilitates faster data processing and centralized maintenance of clinical patient data.

Remote Monitoring & SDV

Cloudbyz products facilitate remote monitoring and remote source data verifications along with query management, action item tracking, follow-up letter generation and tracking, automatic report roll-up to eTMF, etc.

Protocol Deviation & Adverse Events

Cloudbyz solution offers adverse events (AE) and assessment management software under its safety and pharmacovigilance solution. We also focus on protocol deviations through real-time tracking, work-flow alert raises and analysis of any study trials.