Clinical

OneClinicalTrial Platform

The OneClinicalTrial Platform is an Integrated Digital Clinical Trial Platform which enables Sponsors, CROs, and Research Sites work collaboratively and manage all aspects of clinical trials effectively in one place.

Apart from Improving the Clinical Trial Performance, this system enables Sponsors, CROs and Research sites to manage their Regulatory & Quality processes including Safety Reporting, Documentation management, Training management, CAPA, Change controls, Deviations and Audits electronically.

This One-Stop Solution eliminates the need for endless emailing between different teams related to clinical trials by integrating them into a single platform. Clinevotech One allows users to access multiple studies in one place with the convenience of managing the tasks assigned across all these tests simultaneously.

ONE CLINICAL TRIAL SYSTEM

One interactive platform to manage all clinical trial aspects including clinical trial operations, clinical data management, inventory, finance, documents, training etc

INTEGRATED QMS

Clinevo OneClinicalTrial is integrated with Clinevo Quality Management System to manage CAPA, Change, Deviations, Audits, Compliance documents , Training etc of a Clinical Trial.

DYNAMIC WORKFLOWS

Clinevo OneClinicalTrial Platform provides easily configurable workflows to meet the Sponsor SOPs and every needs of clinical trials

FASTER USER ADOPTION

Business team, CROs, and others can be trained on the Clinevo OneClinicalTrial Platform within few hours.

REGULATORY INSPECTION READY

Clinevo OneClinicalTrial Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo OneClinicalTrial is the best User-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers

COMPLIANCE ALERTS

Clinevo OneClinicalTrial Platform provides the best end user alerts for Regulatory documents, Discrepancies, Milestones, Site and Subject visits, Tasks / action items, Trainings of the clinical trials

COST EFFECTIVE & HIGH PERFORMING

Clinevo OneClinicalTrial is a cost-effective system comes with the best transparent optimized pricing. Clinevo OneClinicalTrial is built on a Committed Infrastructure, hosting, training, business process and 24/7 Application support.

INBUILT METADATA (MDR) AND MASTER DATA MGMT. (MDM)

Clinevo OneClinicalTrial ships with inbuilt Metadata and Master data management module to manage Study Global libraries, Sites, Investigators, Products and other master data in a centralized repository and provides a higher level of reusability of the information in different clinical trials.

REAL TIME MONITORING, DASHBOARDS AND REPORTING

Clinevo OneClinicalTrial provides powerful and actionable dashboards and reports for real time monitoring and tracking of study and site statues

Clinical Trial Management System (CTMS)

Clinevo Clinical Trial Management System (CTMS) is a cloud based, highly configurable, "end-to-end platform which" helps manage all aspects of clinical trials including :

Site Monitoring Visits

Milestones - Planning and Tracking

Activities - Tasks  & Deviations

Payments - Site & Investigator

Investigational Product (IP) Tracking &  Inventory (IWRS)

Patient Recruitment & Randomization (IWRS)

Patient Visits - Scheduling and Tracking

Site Selection, Site Initiation, Investigator Selection

Master Data Management (Sites, Investigators)

Regulatory documents & Compliance Tracking

Study Budgets & Training Management

Adverse Event Tracking and many more.

Clinevo Clinical Trial Management System (CTMS) meets the regulatory guidelines including security, access control, change controls, audit trails, and the best system validation.

A Clinical Trial Management System (CTMS) is a software application that supports the Clinical trial processes. It provides infrastructure, consisting of three components: Clinical Data Management System (CDMS), Site Management System (SMS), and a Patient Recruitment Database or a Clinical Trial Web Portal that enable a site to plan, implement, monitor, analyze and report on clinical research activities to maximize the probability of delivering high-quality data within time and budget constraints.

 ONE CLINICAL TRIAL SYSTEM

An end-to-end Clinical Trial Management System (CTMS) system with integration to eTMF and Training Management Systems

COMPLIANCE ALERTS

Clinevo CTMS is one of the best Clinical Trial Management System (CTMS) provides end user alerts for regulatory documents, milestones, site and subject visits, tasks / action items, trainings of the clinical trials

DYNAMIC WORKFLOWS

Clinevo Clinical Trial Management System (CTMS) provides easily configurable workflows to meet the Sponsor SOPs and every requirement of clinical trials

INTEGRATED MASTER DATA MANAGEMENT

Clinevo Clinical Trial Management System (CTMS) is the best CTMS that ships with an inbuilt Master Data Management module to manage Sites, Investigators, Products and other master data in a centralized repository provides a higher level of reusability of the information in different clinical trials.

FEATURE-RICH AND FLEXIBLE

Clinevo Clinical Trial Management System (CTMS) consists of documents, activities, contacts, schedules, payments, milestones and more.

REGULATORY INSPECTION READY

Clinevo Clinical Trial Management System (CTMS) complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

REAL TIME MONITORING AND REPORTING

Clinevo Clinical Trial Management System (CTMS) provides powerful and the best actionable dashboards and reports for real time monitoring and tracking of study and site statuses

COST EFFECTIVE & HIGH PERFORMING

Clinevo Clinical Trial Management System (CTMS) is the best CTMS that comes with transparent optimized pricing.Clinevo CTMS is the best Clinical Trial Management System (CTMS) which is built on a committed infrastructure, hosting, training, business process and provides the best 24/7 application support.

FASTER USER ADOPTION

Business team, CROs, and others can be trained on the Clinevo Clinical Trial Management System (CTMS) within few hours.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo Clinical Trial Management System (CTMS) is user-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers.

Master Data Management (MDM)

Clinevo Master data management (MDM) is a cloud-based Master Data Management software to manage SITES, INVESTIGATORS and other clinical trial information in a centralized means to ensure the uniformity, accuracy, semantic consistency and reusability across Clinical Trials.

Clinical Trial Manager is a powerful and intuitive platform to manage clinical trials. It helps you map your trial's protocols, randomization schedules, site contracts, budgets, and enrolling strategies in a clear and concise platform with customizable Dashboards to track progress at a glance. Connects seamlessly with our Cloud Master Data Management solution - Clinevo Master data management (MDM)

CTMS AND OTHER SYSTEM INTEGRATIONS

Clinevo Master Data Management (MDM) provides interfaces to CTMS, EDC and other Clinical and non-clinical systems.

FASTER USER ADOPTION

Business team, CROs, and others can be trained on the Clinevo Master Data Management (MDM) within few hours.

IMPROVED EFFICIENCY

Clinevo Master Data Management (MDM) builds a single data source that eliminates duplication of data and thus increases the efficiency of the business processes.

IMPROVED GOVERNANCE

By consolidating your data in one place, all stakeholders have access to the most up to date data with Clinevo Master Data Management (MDM).

COMPLETE INFORMATION MANAGEMENT

Clinevo Master Data Management (MDM) provides the best features to manage detailed information about every Site or Personal/Investigator

REGULATORY INSPECTION READY

Clinevo Master Data Management (MDM) Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo Master Data Management (MDM) is the best User-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers

SINGLE VERSION OF THE TRUTH

Clinevo Master Data Management (MDM) ensures that an organization does not use multiple (potentially inconsistent) versions of the same master data in different parts of its Clinical Trials / Operations

COST EFFECTIVE & HIGH PERFORMING

Clinevo Master Data Management (MDM) is a cost-effective system comes with transparent optimized pricing. Clinevo Master Data Management (MDM) is built on a Committed Infrastructure, hosting, training, business process and provides the best 24/7 Application support.

DYNAMIC WORKFLOWS

Clinevo OneClinicalTrial Platform provides easily configurable workflows to meet the Sponsor SOPs and every needs of clinical trials

Electronic Trial Master File (eTMF)

Clinevo electronic Trial Master File (eTMF) is an easy to use electronic Trial Master File in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials. Clinevo electronic Trial Master File (eTMF) has inbuilt DIA reference model and meets regulatory guidelines including: Digital Content Archiving, Security and Access Control, Change Controls, Audit Trails andSystem Validation

Inbuilt & Configurable DIA TMF Structure 

Clinevo electronic Trial Master File (eTMF) software comes with a prebuilt DIA reference model & also allows organizations to define their own / Sponsor specific TMF structure

File Planning & Milestones Setup

Clinevo electronic Trial Master File (eTMF) software allows companies to create a File /Study Plan along with milestones at the study level, country level, and site level.​

Live Tracking of Missing Documents

Based on the file plan, Clinevo electronic trial master file (eTMF) system tracks the status of the documents & monitors the TMF compliance at every level.

Document Lifecycle and Version Control

Clinevo electronic Trial Master File (eTMF) is one of the best eTMF software which has a robust document lifecycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality

Advanced Analytics

Clinevo electronic Trial Master File (eTMF) System is the best eTMF that provides advanced analytics to track Completeness, Quality, Timeliness and TMF compliance of a study.

Bulk / Quick upload with Dynamic Indexing

Clinevo electronic Trial Master File (eTMF) System allows users to upload hundreds of documents in one go using a simple drag and drop & provides dynamic indexing options for documents

External Systems Integration

Clinevo electronic Trial Master File (eTMF) software is the best eTMF that can be Integrated with CDMS/ CTMS systems to get the study, site, patient and other information and dynamically create Directory structure.

Sharing and Collaboration

Clinevo electronic Trial Master File (eTMF) System allows users to invite external parties to upload and work collaboratively on documents in a controlled method

Faster User Adoption

Business TeamS, CROs, Site personnel, External Vendors and others can be trained on the Clinevo electronic Trial Master File (eTMF) System within few hours

Anytime, Anywhere & Any device

Clinevo electronic Trial Master File (eTMF) System is the best user friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers.

Regulatory Inspection Ready

Clinevo electronic Trial Master File (eTMF) System complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines.

Extendable Document Management System

Clinevo electronic Trial Master File (eTMF) System is the best eTMF that can be used as a focused eTMF or as a general document management system for the clinical trials.

Electronic Investigator Site File (eISF)

Clinevo electronic Investigator Site File (eISF) is a cloud based, easy-to-use and highly secured electronic document management platform for investigator sites involved in the clinical trial for full control over their investigator site files (ISF).

Clinevo electronic Investigator Site File (eISF) meets regulatory guidelines including:

Digital content archiving,

Security and access control, 

Change controls, 

Audit trails, and 

System validation. 

CONFIGURABLE ISF STRUCTURE 

Clinevo electronic Investigator Site File (eISF) system comes with a pre-built eISF reference model & also allows organizations to define their own / Study / Site specific ISF structure

FILE PLANNING & MILESTONES SETUP

The Clinevo electronic Investigator Site File (eISF) system allows companies to create a File Plan along with milestones at the study / site level

LIVE TRACKING OF MISSING DOCUMENTS

Based on the file plan, Clinevo electronic Investigator Site File (eISF) system tracks the status of the documents & monitors the ISF compliance at every level.

DOCUMENT LIFECYCLE AND VERSION CONTROL

Clinevo electronic Investigator Site File (eISF) is one of the best eISF software which has a robust document lifecycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality

ADVANCED ANALYTICS

Clinevo electronic Investigator Site File (eISF) System is the best eISF that provides advanced analytics to track Completeness, Quality, Timeliness and TMF compliance of a study.

BULK / QUICK UPLOAD

Clinevo electronic Investigator Site File (eISF) System allows users to upload hundreds of documents in one go using a simple drag and drop & provides dynamic indexing options for documents

INTEGRATION WITH ETMF

Clinevo electronic Investigator Site File (eISF) software can be integrated with the eTMF systems to automatically file selected documents into eTMF

SHARING AND COLLABORATION

Clinevo electronic Investigator Site File (eISF) software allows a user to invite external parties to upload and work collaboratively on documents in a controlled manner

FASTER USER ADOPTION

Site personnel, investigators and others can be trained on Clinevo electronic Investigator Site File (eISF) system within few hours.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo electronic Investigator Site File (eISF) System is the best user friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers

REGULATORY INSPECTION READY

Clinevo electronic Investigator Site File (eISF) system complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines.

Remote Monitoring | rSDV​

Clinevo Clinical Trial Remote Monitoring Systems(RMS) is a web based & easy-to-use software which enables companies to perform remote Source Data Verification (rSDV) / remote Source Data Review (rSDR) without having monitors travelling to the sites.

Clinevo Remote Monitoring System for Clinical trials - meets regulatory guidelines including :

Redacting personal / sensitive information,

Version control,

Security and access control, 

Change controls,  

Digital content archiving,  

Audit trails, and 

System validation. 

Remote Clinical Monitoring is a web-based and easy-to-use software that enables sites and CROs to perform remote SDV/RSDV easily and securely.

It was developed by Clinevo – a leading enterprise GRC SaaS company with extensive analytics domain expertise. This solution allows clients to monitor data from all types of clinical trials such as multi-center, multi-country, Phase II-IV (in any geography), or single-center (if required). Our clientele comprises large Biotechs (>100), Pharma (>300), and CROs (~350). We have successfully handled FDA inspections for multiple prestigious

LIVE TRACKING & STATUSES

Based on the file plan, the Clinevo Clinical Trial Remote monitoring software tracks the remote Source Data Verification (rSDV) status at every level of a clinical trial

CONFIGURABLE SOURCE DATA VERIFICATION

Clinevo Remote Monitoring System for Clinical Trials (RMS) is the best rSDV that ships with a pre-built reference model & also allows organizations to define their own / Study / Site/ Patient specific references for remote Source Data Verification (rSDV)

FILE PLANNING & MILESTONES SETUP

The Clinevo Remote Monitoring System for Clinical Trials allows companies to create File Plan , milestones and placeholders at the Study / Site / Patient / Visit level for remote Source Data Verification (rSDV)

DOCUMENT LIFECYCLE AND VERSION CONTROL

Clinevo Clinical Trial Remote Monitoring Software (RMS) is one of the best rSDV software which has a robust document lifecycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality for managing remote Source Data Verification (rSDV) and remote Source Data Review processes

ADVANCED ANALYTICS

Clinevo Remote Monitoring System for Clinical Trials (RMS) provides advanced analytics to track Completeness, Quality, Timeliness and Source Data Verification (SDV) compliance of a clinical trial.

BULK / QUICK UPLOAD

Clinevo Clinical Trial Remote Monitoring software allows users to upload hundreds of documents in one go using a simple drag and drop & provides dynamic indexing options for documents

REDACTION OF INFORMATION

System provides options to redact sensitive information from the site / patient / visit documents.

SHARING AND COLLABORATION

Clinevo Clinical Trial Remote Monitoring Software is the best rSDV allows users to invite external parties to upload and work collaboratively on documents in a controlled method

FASTER USER ADOPTION

Site personnel, Monitors and others can be trained on Clinevo Remote Monitoring System for Clinical Trials within few hours for remote Source Data Verification (rSDV) / remote Source Data Review

ANYTIME, ANYWHERE & ANY DEVICE

User-friendly and the best rSDV web application can be accessed with internet / intranet using IE, Chrome and Firefox browsers and on any device which enables real-time site collaboration and document exchange

REGULATORY INSPECTION READY

Clinevo Clinical Trial Remote Monitoring Software complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines for enabling remote Source Data Verification (rSDV) / remote Source Data Review

EXTENDABLE DOCUMENT MANAGEMENT

System can be used as a focused clinical trial Remote Monitoring software for remote Source Data Verification (rSDV) or as general document management system for a clinical trial.

Electronic Data Capture (EDC) / eCRF

Clinevo EDC/eCRF is a cloud based, easy to use, regulatory Compliant, end to end Electronic Data Capture (EDC) / eCRF system.

ONE CLINICAL DATA MANAGEMENT SYSTEM

Clinevo Electronic Data Capture (EDC) / eCRF is an One interactive platform to manage all clinical data management aspects including Study Planning, Study build, Study Conduct, Discrepancy / Queries management, Medical Coding, Data Extract, etc.

INTEGRATED QMS

Clinevo Electronic Data Capture (EDC) / eCRF is integrated with Clinevo Quality Management System to manage CAPA, Change, Deviations, Audits, Compliance documents , Training etc of a Clinical Trial.

INTEGRATED MEDICAL CODING

Clinevo Electronic Data Capture (EDC) / eCRF provides inbuilt medical coding feature to setup Meddra and WHODD dictionaries and code the clinical data using these dictionaries seamlessly

REGULATORY INSPECTION READY

Clinevo Electronic Data Capture (EDC) / eCRF is the best EDC that Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

FASTER USER ADOPTION

Business team, CROs, and others can be trained on the Clinevo Electronic Data Capture (EDC) / eCRF within few hours.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo Electronic Data Capture (EDC) / eCRF is the best EDC application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers

REAL TIME MONITORING, DASHBOARDS AND REPORTING

Clinevo Electronic Data Capture (EDC) / eCRF provides powerful and actionable dashboards and reports for real time monitoring and tracking of study and site data and discrepancy / queries

INBUILT METADATA (MDR) AND MASTER DATA MGMT. (MDM)

Clinevo Electronic Data Capture (EDC) / eCRF is the best EDC that ships with inbuilt Metadata and Master data management modules to manage Study Global libraries, Sites, Investigators, Products and other master data in a centralized repository and provides a higher level of reusability of the information in different clinical trials.

COST EFFECTIVE & HIGH PERFORMING

Clinevo Electronic Data Capture (EDC) / eCRF is the best EDC system that comes with transparent optimized pricing. Clinevo Electronic Data Capture (EDC) / eCRF is built on a Committed Infrastructure, hosting, training, business process and provides the best 24/7 Application support.

Metadata Repository (MDR)

Clinevo Metadata Repository (MDR) is a cloud based, regulatory compliant MDR which enables enterprise metadata management to facilitate the desired level of standards maintenance across the organization.

ONE STANDARD ACROSS ORGANIZATION

Clinevo Metadata Repository (MDR) facilitates enterprise metadata management to facilitate the desired level of standards maintenance across the organization.

IMPROVED GOVERNANCE

Clinevo Metadata Repository (MDR) helps organizations to helps securing and governing the Data Standards from multiple sources and to multiple downstream systems.

EFFICIENT STANDARDS MANAGEMENT

Clinevo Metadata Repository (MDR) helps organizations to build a centralized metadata repository where every Metadata Standards (ex: CDASH, SDTM, ADAM, Other Organizations metadata and Standards etc.) can be maintained and found in one place.

REUSABILITY OF STANDARDS

Clinevo Metadata Repository (MDR) Standards can be reused in different studies and in different standardization programs with one click copy which increases the reusability and saves a lot of time creating standards.

DYNAMIC WORKFLOWS

Clinevo Metadata Repository (MDR) provides easily configurable workflows to meet the Sponsor SOPs and every needs of clinical trials

FASTER USER ADOPTION

Business team, CROs, and others can be trained on the Clinevo Metadata Repository (MDR) within few hours.

REGULATORY INSPECTION READY

Clinevo Metadata Repository (MDR) Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

ANYTIME, ANYWHERE & ANY DEVICE

Clinevo Metadata Repository (MDR) is the best User-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers