B3/C3 Format Approved Software Systems
The following software systems are all approved within the WHODrug Vendor Programme for handling B3/C3 format data. This is applicable for the version of the software that was approved and for future versions of the approved software that maintain the core specifications as the initial approved version. The software systems are listed in alphabetical order.
The software descriptions in this page have been directly provided by the approved software vendors and UMC accepts no liability for accuracy, spelling mistakes or omissions.
Software name and version: agEncoder, v. 7.4.1 and v. 7.4.2
Company: ArisGlobal Software Pvt. Ltd.
Date of initial approval: December 16, 2011
Description: agEncoder medical coding solution provides standard APIs and webservices, it receives verbatim terms from any compatible source system and performs auto-coding against specified medical dictionaries using advanced coding algorithms and defined synonyms. The coded terms are then sent back to the source. System supports adverse event term dictionaries (MedDRA) and product dictionaries (WHODrug, Japanese Drug Dictionary) and delivers upgrade/impact analysis and recoding. Coding specialists can instantly resolve multiple records that use the same term, perform advanced searching, and manually code newly encountered verbatim terms.
Software name and version: AuroraPrime v.1.0.13
Company: Shanghai Yaocheng Health Science & Technlogy C0.
Date of initial approval: December 21, 2021
Description: AuroraPrime Collect is a modern, cloud-based electronic data capture (EDC) solution that puts clinical trials on fast track. Designed by clinical research experts with a user-centered approach, AuroraPrime Collect ensures efficient and accurate data collection, cleansing, management, and reporting throughout Phase I–IV studies, streamlining the clinical trial process and accelerating time-to-market. AuroraPrime Collect provides a unified data platform for all parties—trial sites, pharma companies, CROs—to effectively collaborate and gain early visibility to reliable data, enabling study teams to quickly make sound, confident decisions. AuroraPrime’s highly scalable and configurable software-as-a-service (SaaS) architecture provides a cost-effective and flexible solution for clinical trials of any size or complexity, whether you need to run a study of several patients or a multi-site global project recruiting thousands of patients spanning multiple regions.
Software name and version: Bioknow Medcoding v 3.2
Company: Beijing Bioknow Information Technology Co., Ltd.
Date of initial approval: April 18, 2023
Bioknow MedCoding is an intelligent medical coding system that offers the following features: 1. Supports two medical-related dictionaries: MedDRA and WHODrug.
2. Enables batch import and automatic coding.
3. Offers multiple search methods and supports manual coding and auditing.
4. Facilitates the maintenance of synonym and questioning word libraries and generates queries automatically.
5. Implements version upgrade management.
6. Supports multiple projects on a single platform.
Information technology systems can eliminate the problems of tedious manual coding processes and inconsistencies before and after coding. This can prevent errors that may occur during manual coding, significantly improving the efficiency and quality of coding work.
Software name and version: Captivate v.3.2
Company: ClinCapture Inc.
Date of initial approval: December 23, 2019
Description: Captivate EDC offers privacy and performance to conduct studies of different complexities and budgets. Modules can be added to any package, such as the Captivate Coder for Medical Coding.
Software name and version: Central Coding 6.3.1
Company: Oracle America Inc.
Date of initial approval: May 28, 2010
Description: Central Coding will streamline the coding process. Provides customizable, multilingual, web-based coding and dictionary management software that alleviates the challenge of coding medical terms across clinical trial studies, regions, and languages.
Software name and version: CISYS WebCode, v. 4.0
Company: CISYS LifeSciences, Inc.
Date of initial approval: April 11, 2013
Description: Features and benefits:
• Browser agnostic Web-based platform
• API and web services based integration with external EDC platforms
• Extensive Dictionary Library with all historic and current versions of WHODDE and MedDRA Auto-Coding
• Robust customizable synonym list/thesaurus for both WHODDE and MedDRA coding
• Concurrent support of B2 and B3 formats
• Version Impact Analysis Tools that simplify version migration
• Can be integrated with most EDCs or used as a stand-alone coding solution
• Customized coding review and approval workflows
• Extensive query management system that supports manual, system, and up-version queries
• Ability to apply a code to all matching terms when coding a specific term
• Powerful dictionary search engine. Search by drug name, drug code, ingredient, ATC, preferred, generic, or trade
• Multilevel ATC coding
• Real-time access to coded data and coding metrics
• Point-and-click ease of use, user friendly GUI
• Highly configurable, standards based
Software name and version: Coder2, v. 2.0
Company: XClinical GmbH
Date of initial approval: October 4, 2017
Description: XClinical’s auto-coding Software for WHODrug, Coder2 is a web-based tool to classify health-related data such as adverse events or concomitant medications. It includes standard WHODrug dictionaries to automatically and manually encode verbatim terms by use of powerful search mechanisms. The Coder2 provides an interface for seamless integration with EDC system such as XClinical’s EDC system Marvin via a web service API, eliminating the import/export efforts for data managers. Coder2 includes a review workflow with 21CFR11-compliant signatures. Coded information can be transferred back to the EDC system to allow reporting and queries.
Coder2 key features:
• Web-based system, working on all modern standard browsers
• Versatile search engine for all elements of WHODrug like indication, dosage, ATC
• UMC-certified support for WHODrug B3 and C3 standards
• Automatic and manual coding including sponsor- or study specific set-ups
• Stand-alone web application – can be used independently of any EDC system
• Online participation of sponsor staff for review of difficult cases and validation
• Full audit trail documentation
• Project-based coding (multiple studies can use the same coding instance)
Software name and version: CRIO, v. 1.0
Company: CRIO Inc.
Date of initial approval: October 7, 2021
Description: CRIO's EDC module leverages CRIO's installed base of nearly 1,000 research sites worldwide utilizing its direct-data capture eSource system. CRIO's integrated approach ensures one point of data capture, immediate access to data for sponsors and CRO's, and no need for redundant and burdensome source data verification.
Software name and version: CsafeR v. 1.0
Company: C&R Research
Date of initial approval: May 31, 2022
Description: Individual Case Safety Report submission system which complies with the MFDS Business Rule based on the ICH E2B(R2/R3) Implementation Guide. Support for real-time ICSR transmission and bulk reporting via XML format.
Software name and version: cubeCDMS, v. 1.0
Company: CRScube Inc.
Date of initial approval: July 8, 2016
Description: cubeCDMS® is a cutting-edge solution that comes fully equipped with powerful medical coding tools. Collect, store, and analyze clinical data through our cloud to enhance remote based site services. CRScube solutions are compliant with all relevant national regulations, and as a CDISC ODM certified member is devoted to improving e-data standards worldwide. With cubeCDMS® our sophisticated data representation software lets you view critical data naturally so that your study can take the steps needed to flourish.
• eCRF can be created and deftly managed across all browsers
• Instant verification of data, and pre-packaged reports starts your analysis off the right way
• Improved monitoring functionality
• Workflow and Query generation
• Diverse coding dictionaries options
• WHODrug in the newly updated C3 format
Software name and version: cubeSAFETY, v.1.0
Company: CRScube Inc.
Date of initial approval: February 24, 2021
Description: cubeSafety® is a cloud-based system that streamlines the pharmacological reporting process; all the while being compliant with the regulations of regulatory agencies such as the EMA, PMDA, MFDS, CDE and FDA.
Dacima Clinical Suite
Software name and version: Dacima Clinical Suite, v. 3.3.10 and v. 3.3.11
Company: Dacima Software Inc.
Date of initial approval: November 17, 2017
Description: Dacima Clinical Suite is an off-the-shelf, fully featured electronic data capture (EDC) software that can be used for Randomized Clinical Trials, observational study designs, patient registries, web survey, electronic Patient Reported Outomes (ePRO), and patient diaries. The software includes modules for interactive web randomization, emergency unblinding, drug allocation and inventory management, MedDRA and WHO Drug Dictionary coding.
Software name and version: DATATRAK ONE, v. 14.2.2
Company: DATATRAK International
Date of initial approval: November 24, 2015
Description: The Medical Coding module within our EDC application provides easy online access to targeted medical coding dictionaries. The medical coding module is a single solution for dictionary management, searching, browsing, and batch or interactive coding, as well as generate user-defined synonyms for existing codes.
DBMS Consulting Loading Scripts for Oracle TMS and Custom Query Tool
Software name and version: TMS v5.1.x and CQT
Company: DBMS Consulting, Inc.
Date of initial approval: September 28, 2011
Description: DBMS Consulting’s Custom Query Tool (CQT) serves as a centralized system that will enables companies to create, maintain, and version their own Custom Query lists that are standard within their company as well as their own Custom Query lists specific to their medical products, customized to their safety analysis and regulatory reporting requirements.
Software name and version: DDworks21/EDC plus, v. 01
Company: Fujitsu Limited
Date of initial approval: October 18, 2016
Description: tsClinical DDworks21/EDC plus is viewed as one of the industry’s best EDC. We offer EDC plus and services not only to Japan customers but also global customers. EDC plus can help Monitor/DM/IT to improve data management efficiency while maintaining a high quality and low risk.
• EDC plus can implement master data centralized management with our industry-standard CTMS named tsClinical DDworks21/ASP
•EDC plus can implements data integration with our CDISC metadata management system (named tsClinical Metadata), risk-based monitoring approach visualization system (named Clinical Information) and EMR(Electronic Medical Record) system
Software name and version: eCaseLink, v. 8.x
Company: DSG, Inc
Date of initial approval: February 14, 2013
Description: eCaseLink™ EDC has been in continuous use by sites in 93 countries since 1999. It includes an automatic and interactive encoder, enabling credentialed users to perform all medical coding tasks within one fully integrated platform using the UMC dictionary versions for which they hold licenses.
Software name and version: eClinical MedCoder, v. 3
Company: Shanghai University of Traditional Chinese Medicine
Date of initial approval: December 28, 2020
Description: eClinical MedCoder is an auto-coding Software. It supports automatically and manually coding with WHODrug and MedDRA dictionaries by use of powerful search mechanisms.
• Stand-alone web application – can be used independently of any EDC systems.
• Automatic and manual coding including sponsor or study specific setups.
• Synonym list management for both WHODrug and MedDRA coding.
• Customized coding review and approval workflows.
• Dictionary Up-versioning.
• Full audit trail documentation.
• Friendly tool to Chinese users with intelligent recommendation for Chinese version.
Software name and version: Eclipse Coding, Q3 2016 or later
Company: Eclipse Enterprise Solutions, LLC.
Date of initial approval: February 28, 2011
Description: Eclipse Coding is a web-based, centralized coding solution that can integrate with leading EDC and Safety applications for the conduct of medical and drug coding in clinical trials. Eclipse Coding's configurable workflow streamlines the coding process and improves coding turnaround time.
• Manage and code with multiple dictionaries, versions and formats
• Code all studies at once or one at a time
• Multi-center connectivity in our world-class SaaS environment provides high performance for global coding teams
• Robust synonym management & Impact Analysis
• Advanced search functions for increased hit rates
Software name and version: eCollect v5.10
Company: Zhejiang Taimei Medical Technology Co., LTD
Date of initial approval: November 7, 2016
Description: eCollect (Electronic Data Capture System) is a software system developed for pharmaceutical industries to effectively manage clinical data. Both Chinese and English versions of the software are available to meet regulatory requirements. Coding system including WHODrug and MedDRA are inbuilt in the softwares.
Software name and version: EDCON v3.5.3
Company: Shanghai Shanhu Health Technology
Date of initial approval: May 25, 2022
Description: EDCON is flexible and user friendly electronic data capture system designed for global clinical trials by Shanhu Health. The concept of low-code is well built in EDCON product from the very beginning to make complex simple especially for the edit checks. And the batch test for edit checks and eCRF online review modules ensure what you get is what you see in CRF design and built in EDC. By doing this, Shanhu Health can accelerate drug development with data intelligence during clinical trial startup phase.
Software name and version: eSafety (eVigi) v4.8
Company: Zhejiang Taimei Medical Technology Co., LTD
Date of initial approval: June 27, 2019
Description: eSafety(eVigi) is a professional information system that can be applied to the field of pharmacovigilance in China and worldwide. eSafety(eVigi) integrates clinical research and post-marketing product safety data and is committed to building a database of product safety information for the enterprise, safeguarding the company's products, effectively managing risks, and achieving the goal of ensuring patients' drug safety.
Gooclin Pharmacovigilance System
Software name and version: Gooclin Pharmacovigilance System v 1.0
Company: Guilin Gooclin Technology Co., Ltd.
Date of initial approval: January 12, 2022
Description: Gooclin Pharmacovigilance System (Gooclin-PV) is a SaaS cloud-based pharmacovigilance information management system focused on providing a one-stop and complete solution for managing drug and drug-related safety information. This system covers the whole life cycle of drug pharmacovigilance work process, including data collection, evaluation, submission and follow-up of drug information, signal detection, data analysis and safety report export. It aims to help pharmaceutical enterprises to manage drug safety information and achieve safety risk management.
Software name and version: HALOPV 2.3
Company: Insife ApS
Date of initial approval: May 6, 2021
Description: HALOPV is a comprehensive drug safety system, capable of case intake, processing, submission as well as providing capabilities for aggregate reporting, regulatory intelligence, signal and risk management, PSMF, SDEA, literature monitoring etc. HALOPV is built on modern APIs and artificial intelligence for automation.
Software name and version: Haversac 1.6.0
Company: Mediant Health, Inc.
Date of initial approval: September 21, 2017
Description: Haversac Coding can work in tandem with Haversac EDC to ease query management, or as a stand-alone coding solution for imported records. Verbatim language is automatically loaded on record selection and search type and filters are single instant result choices. Coded records are segregated by a completed filter for easier workflow management, and coding time is automatically calculated to ease expense tracking.
Software name and version: HoloX@ClinSafety v 1.0
Company: Beijing Holox Network
Date of initial approval: March 1, 2023
Description: The clinical pharmacovigilance system is mainly used for the processing, coding and submission of AE reports generated during drug research and development.
Software name and version: iMedNet,v. 1.172.2
Company: MedNet Solutions, Inc.
Date of initial approval: July 3, 2014
Description: iMedNet EDC is MedNet Solutions’ latest EDC/eClinical technology platform. It provides nontechnicalclinical research personnel with a fast, intuitive and cost-effective solution for building and managing clinical studies.
Software name and version: iTrial Genies v.3.1
Company: Shanghai Renxun Technology
Date of initial approval: Sept 8, 2022
Description: iTrial Genies is a One-Stop Platform for CROs,Pharma which integrates EDC, CTMS, VMS, MDA,eTMF,PVS systems. Users can capture and handle clinical data in this platform efficiently and accurately through new IT technologies such as AI, Machine Learnings.
Software name and version: Jazz Safety v 1.0.23095.1
Company: ANOVA S.R.L.
Date of initial approval: April 10, 2023
Description: Jazz Safety is a comprehensive, fully-validated, E2B (R3) compliant and web-based pharmacovigilance software which enables end-to-end management of safety reports associated with drugs, medical devices, biologic products and/or cosmetics during the whole product lifecycle. It also provides capabilities for signal detection, storage of Pharmacovigilance Dept. documentation and regulatory management for individual and aggregate safety reports. Supported languages: Spanish, Portuguese and English.
Software name and version: MainEDC 4.0
Company: Data Management 365, LLC
Date of initial approval: December 20, 2019
Description: MainEDC system contains 3 components: EDC, IWRS and automated drug supply. One of the EDC component functionalities is a built-in medical coding tool, compatible and currently used with MedDRA, ATC and ICD-10 dictionaries. Our system’s target users are Sponsor/CROs conducting clinical trials.
Software name and version: Maven CDMS v.1.0
Company: JNPMEDI Inc.
Date of initial approval: November 19, 2021
Description: Maven CDMS is a solution created for the purpose of contributing to the advancement of the medical data platform. A cloud-based application that has strengths in business flexibility, ease of use, and operational excellence by adopting a responsive UI and has the capability to play a leading role in the global market.
• Easy to collect and manage data in response to various clinical types
• Various types of medical coding dictionaries such as WHODrug B3 / C3 and MedDRA are provided
• User-oriented detailed query logic setting
• Electronic case report (eCRF) development, subject visit management logic freely setting
• Randomization and Investigational Drug (IP) supply management support
Software name and version: MedCodr, v. 1.0
Company: Prudentia Group LLC
Date of initial approval: October 30, 2017
Description: MedCodr is a web-based solution for coding medical verbatim terms and products to standard dictionaries including MedDRA and WHODrug or custom dictionaries. MedCodr provides a powerful, efficient and accurate auto-coding to verbatim to improve quality and consistency. It integrates with leading safety, clinical data management and EDC systems or in-house databases. Some of the features of MedCodr are:
• Supports multi-lingual dictionaries
• Configurable and efficient auto-coding
• Support for SDG, SMQ, and custom concepts
• Synonym management workflow with up-versioning
• Systematic impact assessment and coded data up-versioning
• Organize and share project/studies across users/groups
• Verbatim intake via manual, file, web method or database integration route
• Easy and intuitive user interface
• Supports multiple web browsers
• Metrics on quality/consistency of coding
• Audit log of all activities
• Hosted or on premise installation
Software name and version: Medrio, v. 39.3
Company: Medrio, Inc.
Date of initial approval: April 25, 2012
Description: Medrio EDC – Fast and flexible electronic data capture in your clinical trials, with you in charge. Handle database build, mid-study changes, and more with no reliance on programmers or external parties, unlocking essential speed and efficiency.
Software name and version: Medsignal 1.6
Company: Caparna AG
Date of initial approval: November 2, 2023
Description: Medsignal is a vanguard complete pharmacovigilance system throughout life cycle of drugs, vaccines, and devices with state of the art capabilities in signal detection, signal management, risk mitigation, seamless Vigibase and WHO-Drug integration making the system first in its class and first tool to be designed by safety scientists. It allows for the integration of any safety or clinical database system and powerful for private industry and government entities.
Software name and version: Oracle Arugs Safety 8.2.2
Company: Nextrove, LLC
Date of initial approval: October 9, 2020
Description: Nextrove responsibilities - We will be hosting the Argus Safety Database on our cloud platform and provide access to Sponsors and CROs who will do case processing and submission. Nextrove will be responsible for managing Argus database, uploading the WHODrug dictionary files whenever a new version is provided by UMC. Our key area of expertise is around Safety Database Management. We will also ensure that both CROs and well as Sponsor continue to have a current version of WHODrug by doing their annual audits and providing a copy to UMC for record keeping.
Software name and version: Nukleus EDC v. 2
Company: nuvoteQ (Pty) Ltd
Date of initial approval: August 11, 2022
Description: Nukleus is our Electronic Data Capture (EDC) platform built for the emerging market, making use of first world technologies. Our EDC platform is a web-based computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials and can be accessed using any device. Nukleus EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. Our solution allows the customer to configure their study entirely through the front-end. The configuration includes role-based access, edit-check validators, skip/add logic, derived field calculations and more. The structure of the platform follows the idea of a Participant file, where each file contains several different folders (which can represent a Participant visit) with a number of different forms/procedures within that folder. Each of the forms/procedures contains one or more questions/data-points which is captured against a specific Participant.
Software name and version: Octalsoft EDC 4.0
Company: Glorant India
Date of initial approval: May 25, 2021
Description: Octalsoft EDC is a comprehensive cloud-based software with a responsive layout that provides a simple user interface to capture trial subject data with ease. With integrated online edit checks and query management features, users can capture quality data with speed and accuracy. The system’s powerful reporting capabilities help study teams visualize and analyze study data in real-time. By leveraging open standards, it allows for easy integration of clinical and non-clinical data from multiple sources.
Oracle Argus Safety Enterprise Edition
Software name and version: Oracle Argus Safety Enterprise Edition, v. 8.1.1-8.1.3, 8.2, 8.2.1
Company: Oracle America Inc.
Date of initial approval: September 8, 2017
Description: Argus Safety will help in achieving Compliance, Quality, and Efficiency in Safety Operations. Provides a comprehensive pharmacovigilance platform enabling manufacturers to make faster and better safety decisions, optimize global compliance, and integrate risk management into key processes.
Oracle Thesaurus Management System
Software name and version: Thesaurus Management System, v. 5.1.2/5.2.1
Company: Oracle America Inc.
Date of initial approval: July 25, 2017
Description: Oracle Thesaurus Management System (TMS) addresses the complexities associated with managing global thesauri. Designed to manage and classify free text captured during the drug development process, TMS meets the needs of multinational pharmaceutical, biotechnical, and medical device companies, contract research organizations, academic institutions, and regulatory authorities by providing a worldwide, scalable terminology repository.
• Global centralized terminology management
• TMS classification engine supports mapping verbatim terminologies to standard terminologies
• Supports outsourcing verbatim term classification tasks
• Supports custom or vendor supplied dictionaries
• Supports dictionary versioning and access to previous versions
• HTML browser provides enterprise-wide repository searching
• API-driven interface enables custom application integration
• Role-based security allows both data- and function related access
• Workflow implementation facilitates control and reporting of user activities
Software name and version: PACE, v. 3.3
Company: Clearight Information Systems, LLC
Date of initial approval: October 1, 2013
Description: PACE is a web-based, advanced, multi-dictionary coding and management system that is designed to provide accurate and consistent coding output with increased productivity and quality. PACE’s intelligent and self-learning synonym list automatically adapts itself to the coding conventions to ensure high auto-coding hit rate and the inbuilt scoring algorithm with suggestions helps to code and review terms more consistently and accurately with increased efficiency.
PACE can be integrated with any existing safety and clinical system. PACE can be used as central coding system to batch code both ongoing and legacy data (recoding). PACE supports multi version MedDRA & WHODrug along with any legacy or custom dictionaries. The in-built dictionary management tool helps manage loading and maintenance of dictionary versions with ease.
• Simultaneous multiple dictionary versions including MedDRA & WHODrug.
• In-built scoring algorithm with suggestion for accurate and consistent coding
• Integrate with any safety and clinical database
• Role based security and access with audit trail
• Rapid batch recoding
• E2B import / export for data exchange with external systems
PV-Works / PV-247
Software name and version: PV-Works (Saas solution branded as PV-247), v. 3
Company: Ennov PV
Date of initial approval: March 23, 2018
Description: PV-247 is a comprehensive solution designed to meet all current regulations, including electronic reporting and safety surveillance, in a cost-effective package that is ready-to-go via the internet.
Rave Coder with ML
Software name and version: Rave Coder with ML, v. 2017.2.0
Company: Medidata Solutions, Inc.
Date of initial approval: June 18, 2018
Description: Rave Coder with ML is a cloud application that streamlines and centralizes medical coding. It works seamlessly with Medidata Rave and also integrates with any non-Rave EDC system.
Software name and version: REDCap Cloud 1.4 and 1.5
Company: nPhase, Inc.
Date of initial approval: March 30, 2017
Description: REDCap Cloud's Unified Data Management platform empowers organizations to collect, integrate, analyze and share health data in a standards-based way to make the right decisions at the right time. REDCap Cloud EDC is fully integrated in the platform and streamlines coding with WHODrug C and C3 format dictionaries.
Riehen Electronic Data Capture System
Software name and version: Riehen Electronic Data Capture System v. 2.1.1614
Company: Xi’an Riehen Life Science Technology Co.Ltd
Date of initial approval: Febuary 16, 2023
Description: Riehen EDC system is a new generation of EDC system with high availibilty and capacity, pass the ISO9001,ISO27001 and a series international standard.
Software name and version: Safetybase v. 2
Company: nuvoteQ (Pty) Ltd
Date of initial approval: August 11, 2022
Description: Safetybase, our electronic Pharmacovigilance (ePhV) platform is a web-based platform designed to collect in-trial safety related data and replaces the traditional paper-based data collection methodology to streamline data collection and ensure real-time safety event reporting. Reporting of safety events can be linked to a notification platform which in turn alerts the respective safety teams of new events coming in. Safetybase can also be used to facilitate post-market safety surveillance whereby users can capture any Adverse Drug Reactions, Product Complaints or Medical Information Requests for an already registered product. Our solution allows the customer to configure their safety database entirely through the front-end. The configuration includes role-based access, edit-check validators, skip/add logic, derived field calculations and more. The structure of the platform follows the idea of an Event file, where each file contains several different folders with a number of different forms/sections within that folder (replicating your standard paper-based safety reporting format). Each of the forms/sections contains one or more questions/data-points which is captured against a specific Event
Software name and version: ShareCRF 2022.01
Company: Inetsys S.L
Date of initial approval: September 14, 2022
Description: ShareCRF is a modern EDC cloud platform designed to be intuitive and easy to use and help Monitors/DM/IT in their daily work. It allows the clinical trial to be designed quickly and without programming skills, using a visual interface that allows great flexibility and can be tailored to multiple types of trials. Perform mid-study changes in minutes securely avoiding impacting the database in a negative way or disrupting users. Keep data from multiple sources unified in one place, ready to analyze data when you need it. It has a wide range of options and tools that helps facilitate clinical research: ePRO, Randomization (RTSM), Trial Supply Management, Field Encryption, Real-Time Advanced edit checks, Medical Coding, DICOM support, Automatic Annotated CRF, Automatic PDF Certified Copy, Electronic Signature, Data Verification, Query Workflow, Automatic Queries, Configurable notifications, Dynamic Conditional Forms and Fields, Automatic Data Cleaning, Export Data on multiple formats, Complete Audit Trail, Reports and more.
Software name and version: Solution EDC System v.4
Company: Solution (Shanghai) Information Technology Co., Ltd.
Date of initial approval: July 22, 2022
Description: Solution EDC system is an innovative EDC system. We integrated ePRO, CTMS, CRS system into one platform. We use technology to make clinical trials more efficient. At present, it has served more than 300 hospitals or pharmaceutical companies.
SyMetric Clinical Trial Platform
Software name and version: SyMetric Clinical Trial Platform v.5
Company: Achiral Systems Pvt. Ltd.
Date of initial approval: January 5, 2023
Description: Integrated Cloud Solution for IRT, EDC and Medical Coding. Built with a vision to support end-to-end processes in Clinical Trials, the Cloud-Based Platform is fully modularized, allowing you customers choose the right solutions to meet the needs of various Study designs. The Platform provides the agility needed for modern trial designs, together with smart cloud solutions and a flexible pricing model for all types of research and academia including Pharmaceutical companies, CRO's and Independent Research Institutions. Global Industry and Regulatory Compliance to 21 CFR Part 11, ICH-GCP, ISO 27001 & ISO 9001.
Software name and version: TARA PV, v. 1.4.2
Company: MedGenesis Ltd
Date of initial approval: December 17, 2012
Description: TARA (Tools for Adverse Reaction Assessment) is a secure, powerful, and cost-effective web-based pharmacovigilance safety database, incorporating WHODrug and MedDRA dictionaries enabling accurate and efficient searching for coding of verbatim terms to improve data quality and analysis.
• Workflow and Role based security allows both data and function related access
• E2B import / export for regulatory reporting and data exchange with external systems
• Full system auditing capabilities
• Secure Tier 4 Cloud solution is provided on dedicated servers, managed and hosted by iDash Ltd.
Software name and version: TransformPV v2.1 / Mar 2021
Company: Vitrana Inc.
Date of initial approval: September 27, 2021
Description: TransformPV would provide capability to automate the mapping of WHO UMC codes to MFDS. Additionally a UI based browser selection would be available to search MFDS codes and also review the mappings to WHO UMC.
Software name and version: TrialKit Coder v. 4.6
Company: Crucial Data Solutions
Date of initial approval: August 22, 2016
Description: Designed to generate results at an unparalleled speed, TrialKit Coder is a highly configurable, accurate medical coding solution that is available on any web browser or mobile device.
Trial Data EDC
Software name and version: Trial Data EDC, v.6
Company: Trial Data Pharmaceutical Technology (Shanghai) Co., Ltd.
Date of initial approval: March 29, 2019
Description: Medical coding module within Trial Data EDC is a web based, centralized solution for coding medical verbatim terms and products to standard dictionaries including WHODrug and MedDRA with features as below:
• Support multi-dictionary version
• Automatic coding
• Intelligent recommendation of search results
• Batch coding
• Maintenance of Synonym
• Batch export of coding results for offline review or archiving
• Terms can link directly to the corresponding CRF for data cleaning and query maintenance
Trial Data also contains: IWRS for randomization and drug management; ERM system for trial risk management; EasyFu system for patient follow-up management etc.
Software name and version: Trial Online, v. 4.16
Company: Replior AB
Date of initial approval: March 24, 2017
Description: Trial Online is a secure, powerful, and cost-effective EDC service fully compliant with 21 CFR Part 11 and GCP. The solution is provided as Software As A Service solution on a dedicated server managed and hosted by Replior AB.
UltraVig - Pharmacovigilance System
Software name and version: UltraVig v.5.6
Company: Ultréia Consultoria Em Informatica Ltda
Date of initial approval: February 15, 2023
Description: The Ultreia’s UltraVig – Pharmacovigilance System is a tool that aims to help Healthcare Companies to adhere to Regulatory Authorities demands, through efficient and effective monitoring of their products safety, through monitoring the Adverse Events suspicions associated with the use of such products, and also supporting on the identification of a causality relationship between the use of the product and the reported Adverse Event. The UltraVig System supports E2B R3.
Software name and version: Vault Safety 19R2
Company: Veeva Systems, Inc.
Date of initial approval: August 1, 2019
Description: Veeva Vault Safety Suite is a comprehensive pharmacovigilance cloud-based solution for managing the end-to-end drug safety lifecycle, enabling more efficient case intake and adverse event processing to authoring and seamless submissions. With a modern approach, it provides a scalable solution with superior user experience and greater visibility into safety cases and process status.
Veeva Vault Coder
Software name and version: Veeva Vault Coder, v. 18R1+
Company: Veeva Systems, Inc.
Date of initial approval: July 16, 2018
Description: A modern, user-centric, and 100% cloud-based application, Veeva Vault Coder is the first true innovation in clinical coding in years. It provides an incredibly intuitive user interface, yielding fast, efficient, and correct coding for any type of clinical trial. Built on the Vault Unified Clinical Platform and seamlessly integrated with Veeva Vault EDC, it supports coding eCRFs with all versions of the WHODrug B3, WHODrug C3, and MedDRA dictionaries.
• Batch Coding
• Synonym Lists
• Dictionary Search
• Verbatim Search
• Queries with in-product discussion threads
• Dictionary Up-versioning
• Metrics on Progress and Prioritization
• Role-Based Security
• Audit Trail
Software name and version: VIEDOC, v. 4.38
Company: Viedoc Technologies AB
Date of initial approval: October 18, 2017
Description: Viedoc is the most modern EDC platform that can be found on the market and contains EDC, ePRO, randomization as well as medical and drug coding modules. The system is provided as a SaaS and allows customers to handle everything from study design and setup to study maintenance and lock completely on their own. Empower your clinical trial, contact us today.
Software name and version: Vision™ v. 10
Company: Prelude Dynamics, LLC
Date of initial approval: November 15, 2021
Description: Prelude Dynamics is a global provider of eClinical Solutions and Services. We partner with researchers and clinicians in both human and animal health, and specialize in supporting complex studies and registries.