MedDRA is the language of communication among pharmaceutical manufactures, regulators and CROs. Therefore, new tools and skills are required. It is strongly recommended to implement a coding tool which answers the internal coding and dictionaries related needs. The coding tool should provide functionalities enabled to:
• Manage MedDRA dictionary updates and all other dictionaries.
• Browse the MedDRA content.
• Code data with the latest updated version of MedDRA dictionary using same synonyms, same stopwords and same algorithm
• Quantify the impact analysis on data before implementing a new version of dictionary
• Edit listings and help improving the synonym table if available
• Provide large capabilities of search at all levels of the dictionary (beginning, containing, ending, and, or, searching for two keywords …)
• Provide patients and sites information
• Audit History
Listed below is a selection of various coding tools available in the market:
1. ID-code
2. DS Navigator
3. Lingway
4. Central Coding 2.1 SP1
5. eClipse Coding (2011)
6. ATOMS, V1.01.01
7. Oracle TMS WHO Drug Dictionary Loading Scripts agEncoder 2.1
8. eClinical, Version 7.0
9. ClinPlus Coding 3.1 (SR-1)
10. TARA
11. eCaseLink v 8
12. Sequence WebCode
Certified Software Packages:
The following Software Packages are currently Certified in the UMC Software
Company: Phase Forward
Software Package Name
Version: Central Coding 2.1 SP1
Date of Certification:
May 28th, 2010
Link: www.phaseforward.com
Description:
Central Coding is a customizable, multilingual, Web-based coding and dictionary management application designed to automate the coding process and minimize the manual effort required to code verbatim terms. Optimized to work with the InForm Global Trial Management (GTM) solution and the ClinTrial data management system, Central Coding streamlines the coding process, increases coding consistency and potentially drives down costs by allowing cross trial coding and effectively managing multiple dictionaries and dictionary versions.
Company: Cerner Corporation
Software Package
Name Version: dsNavigator 2010.01xx
dsNavigator brochure: http://www.cerner.com/uploadedFiles/fl03_697_10_v2_dsNavigator_hr.pdf
Date of Certification: November 23, 2010
Link: http://www.cerner.com/solutions/Research/Drug_Safety_Solutions_and_Services/
Description:
dsNavigator is Cerner Galt's flagship coding and dictionary management solution. This market-leading solution combines functionality for searching, navigating, auto-encoding, and dictionary management in a single application. dsNavigator supports multiple dictionaries and synonym lists and is perfectly suited for pharmaceutical companies, biotechnology and medical device manufacturers, government agencies, and CROs. dsNavigator can be easily integrated with existing safety and clinical systems and is being utilized by companies worldwide.
Company: eClipse Enterprise Solutions, LLC.
Software Package Name Version: eClipse Coding (2011)
Link: http://www.eclipsesol.com/?PID=63
Date of Certification: 28 February, 2011
Description:
eClipse Coding is a web-based coding solution that integrates with leading EDC and CDMS applications for the conduct of medical and drug coding in clinical trials. eClipse Coding workflow streamlines the coding process and improves coding efficiencies. Manage and code with multiple dictionaries, versions and formats. Code all studies at once or one at a time.
Company: Database Integrations
Software Package Name Version: ATOMS, V1.01.01
Date of Certification: September 28, 2011
Link: www.dbintegrations.com
Description:
ATOMS is a web based fully integrated EDC/CTMS/IWRS/TMF system with ever expanding easy to use 100% customizable functionality. Combine ATOMS with our superb knowledge of Clinical Trials and you get the perfect clinical systems solution.
Company: DBMS Consulting, Inc.
Software
Package Name Version: Oracle TMS WHO Drug Dictionary Loading Scripts
Date of Certification: September 28, 2011
Link: http://clinicalserver.com/
Description:
DBMS Consulting has created customized dictionary loading scripts for the WHO Drug Dictionary customers for almost a decade. This script package allows you to load WHO Drug B Format into Oracle's Thesaurus Management System (TMS).
Company: Aris Global LLC
Software Package Name Version: agEncoder 2.1
Date of Certification: December 16, 2011
Link: http://www.arisglobal.com/products/agencoder.php
Description:
agEncoder is a Web-based, centralized coding and dictionary management system, which codes verbatim terms (VTs) from different systems and maintains dictionaries at a central location. agEncoder automates the coding process and minimizes any manual coding effort involved. Integration with ARISg™ and ARISj™, Aris Global’s industry leading pharmacovigilance solutions, enable companies to improve the consistency of trial safety reporting and reduce the efforts to reconcile serious adverse events.
agEncoder supports:
Company: Medrio
Software Package Name Version: eClinical, Version 7.0
Date of Certification: April 25, 2012
Link: http://www.medrio.com
Description:
Medrio provides a fully integrated eClinical software as a service (SaaS) suite including EDC, ePRO, randomization, and coding modules which are all configured through a browser and require no custom programming. Medrio’s SaaS model allows customers to configure studies online in days or weeks rather than months without reliance on Medrio staff. This easy to use, true SaaS offering eliminates the need for programmers and IT infrastructure, resulting in:
• Lower cost
• Shorter setup time
• More control
• Greater flexibility
• Increased visibility
Company: DZS Software Solutions, Inc.
Software Package Name Version: ClinPlus Coding 3.1 (SR-1)
Date of Certification: June 8th, 2012
Link: www.clinplus.com
Description:
ClinPlus Coding from DZS Software Solutions, Inc. uses advanced algorithms that take advantage of custom thesauruses and previous coding tasks to produce the highest auto-coding hit rates. Many flexible searching features are available to simplify manual coding. The system “learns” from manual coding choices to continually improve auto-coding hit rates as the project progresses. Engineered for optimal performance with WHO DDE and MedDRA, ClinPlus Coding also performs very well with custom and legacy dictionaries. Because ClinPlus can code SAS, SQL Server and Oracle data sources, integration efforts with EDC, Safety and other systems are minimized. Since 1997, ClinPlus Coding has been producing consistent, accurate results in a quick and cost-effective manner.
Company: Medgenesis Ltd.
Software Package
Name Version: TARA
Date of Certification:
December 17th, 2012
Link: www.tarapv.com
Description:
Tools for Adverse Reaction Assessment (TARA) is a pharmacovigilance software tool, which provides companies with the facility to monitor products and devices, providing early identifications of risks and safety trends. The solution is being used in clinical safety management for both clinical trials and marketed products. The core design of TARA is consistently
simple, intuitive and most importantly user friendly. TARA’s features have allowed dramatic improvements to the quality and speed of case processing, whilst ensuring data integrity. TARA has been designed from the outset by pharmacovigilance professionals, supported by a team of software developers drawn from both academia and the Information Technology Industry.
Company: DSG, Inc.
Software Package Name
Version: eCaseLink v 8
Date of Certification:
March 14th, 2013
Link: www.dsg-us.com
Description:
DSG, Inc. supports clinical trial data collection and management with innovative and fully integrated technology solutions, including Electronic Data Capture with specialized Clinical Data Management services, IWRS, Clinical Trial Management
Systems, Safety Tracking, and Protocol Violations software. Within eCaseLink™ edc is a fully integrated encoder supporting all versions of WHO drug and MedDRA dictionaries for Adverse Events, ConMeds, and Medical Histories, with all coding work conducted within one screen without need for additional system navigation. This allows real-time exporting of encoded data into SAS datasets and transport files as needed.
Company: Cisys LifeSciences
Software Package
Name Version: Sequence WebCode
Date of Certification: April 11, 2013
Link:www.cisys.com
Description:
Sequence WebCode is a web-based multi-dictionary medical coding system that features a robust search engine with auto-coding capabilities. Integrating Sequence WebCode with the Sequence WebEDC Platform provides a turnkey solution that offers superior value in support of your clinical trials. Highly configurable and standards based, Sequence WebCode can also be easily integrated with other EDC systems.
Features:
• Intuitive user-friendly interface
• WHO DDE and MedDRA Coding
• Dictionary management system with version migration
• Auto-Coding capabilities with intuitive approval workflow
• Customizable Synonym Lists with extensive integration features for both auto-coding and manual coding
• Multilevel ATC coding
• Search by drug name, drug code, ingredient, ATC, preferred, generic, or trade
• Highly configurable, standards based
• API and web services based integration with external EDC platforms
• Browser agnostic
• Manage MedDRA dictionary updates and all other dictionaries.
• Browse the MedDRA content.
• Code data with the latest updated version of MedDRA dictionary using same synonyms, same stopwords and same algorithm
• Quantify the impact analysis on data before implementing a new version of dictionary
• Edit listings and help improving the synonym table if available
• Provide large capabilities of search at all levels of the dictionary (beginning, containing, ending, and, or, searching for two keywords …)
• Provide patients and sites information
• Audit History
Listed below is a selection of various coding tools available in the market:
1. ID-code
2. DS Navigator
3. Lingway
4. Central Coding 2.1 SP1
5. eClipse Coding (2011)
6. ATOMS, V1.01.01
7. Oracle TMS WHO Drug Dictionary Loading Scripts agEncoder 2.1
8. eClinical, Version 7.0
9. ClinPlus Coding 3.1 (SR-1)
10. TARA
11. eCaseLink v 8
12. Sequence WebCode
Certified Software Packages:
The following Software Packages are currently Certified in the UMC Software
Company: Phase Forward
Software Package Name
Version: Central Coding 2.1 SP1
Date of Certification:
May 28th, 2010
Link: www.phaseforward.com
Description:
Central Coding is a customizable, multilingual, Web-based coding and dictionary management application designed to automate the coding process and minimize the manual effort required to code verbatim terms. Optimized to work with the InForm Global Trial Management (GTM) solution and the ClinTrial data management system, Central Coding streamlines the coding process, increases coding consistency and potentially drives down costs by allowing cross trial coding and effectively managing multiple dictionaries and dictionary versions.
Company: Cerner Corporation
Software Package
Name Version: dsNavigator 2010.01xx
dsNavigator brochure: http://www.cerner.com/uploadedFiles/fl03_697_10_v2_dsNavigator_hr.pdf
Date of Certification: November 23, 2010
Link: http://www.cerner.com/solutions/Research/Drug_Safety_Solutions_and_Services/
Description:
dsNavigator is Cerner Galt's flagship coding and dictionary management solution. This market-leading solution combines functionality for searching, navigating, auto-encoding, and dictionary management in a single application. dsNavigator supports multiple dictionaries and synonym lists and is perfectly suited for pharmaceutical companies, biotechnology and medical device manufacturers, government agencies, and CROs. dsNavigator can be easily integrated with existing safety and clinical systems and is being utilized by companies worldwide.
Company: eClipse Enterprise Solutions, LLC.
Software Package Name Version: eClipse Coding (2011)
Link: http://www.eclipsesol.com/?PID=63
Date of Certification: 28 February, 2011
Description:
eClipse Coding is a web-based coding solution that integrates with leading EDC and CDMS applications for the conduct of medical and drug coding in clinical trials. eClipse Coding workflow streamlines the coding process and improves coding efficiencies. Manage and code with multiple dictionaries, versions and formats. Code all studies at once or one at a time.
Company: Database Integrations
Software Package Name Version: ATOMS, V1.01.01
Date of Certification: September 28, 2011
Link: www.dbintegrations.com
Description:
ATOMS is a web based fully integrated EDC/CTMS/IWRS/TMF system with ever expanding easy to use 100% customizable functionality. Combine ATOMS with our superb knowledge of Clinical Trials and you get the perfect clinical systems solution.
Company: DBMS Consulting, Inc.
Software
Package Name Version: Oracle TMS WHO Drug Dictionary Loading Scripts
Date of Certification: September 28, 2011
Link: http://clinicalserver.com/
Description:
DBMS Consulting has created customized dictionary loading scripts for the WHO Drug Dictionary customers for almost a decade. This script package allows you to load WHO Drug B Format into Oracle's Thesaurus Management System (TMS).
Company: Aris Global LLC
Software Package Name Version: agEncoder 2.1
Date of Certification: December 16, 2011
Link: http://www.arisglobal.com/products/agencoder.php
Description:
agEncoder is a Web-based, centralized coding and dictionary management system, which codes verbatim terms (VTs) from different systems and maintains dictionaries at a central location. agEncoder automates the coding process and minimizes any manual coding effort involved. Integration with ARISg™ and ARISj™, Aris Global’s industry leading pharmacovigilance solutions, enable companies to improve the consistency of trial safety reporting and reduce the efforts to reconcile serious adverse events.
agEncoder supports:
- Centralized and Advanced coding
- Triage and prioritization of Coding requests
- Flexible and configurable workflow to support the coding and review process
- Innovative Dictionary and Version management including Impact analysis
- Seamless Integration with ARISg™ and ARISj™
- External system file integration
- WHO Drug Dictionary, MedDRA (English/Japanese) and Japanese Drug Dictionary
- Standard MedDRA Queries (SMQs) and Custom MedDRA Queries (CMQs)
- Precise ATC Coding
Company: Medrio
Software Package Name Version: eClinical, Version 7.0
Date of Certification: April 25, 2012
Link: http://www.medrio.com
Description:
Medrio provides a fully integrated eClinical software as a service (SaaS) suite including EDC, ePRO, randomization, and coding modules which are all configured through a browser and require no custom programming. Medrio’s SaaS model allows customers to configure studies online in days or weeks rather than months without reliance on Medrio staff. This easy to use, true SaaS offering eliminates the need for programmers and IT infrastructure, resulting in:
• Lower cost
• Shorter setup time
• More control
• Greater flexibility
• Increased visibility
Company: DZS Software Solutions, Inc.
Software Package Name Version: ClinPlus Coding 3.1 (SR-1)
Date of Certification: June 8th, 2012
Link: www.clinplus.com
Description:
ClinPlus Coding from DZS Software Solutions, Inc. uses advanced algorithms that take advantage of custom thesauruses and previous coding tasks to produce the highest auto-coding hit rates. Many flexible searching features are available to simplify manual coding. The system “learns” from manual coding choices to continually improve auto-coding hit rates as the project progresses. Engineered for optimal performance with WHO DDE and MedDRA, ClinPlus Coding also performs very well with custom and legacy dictionaries. Because ClinPlus can code SAS, SQL Server and Oracle data sources, integration efforts with EDC, Safety and other systems are minimized. Since 1997, ClinPlus Coding has been producing consistent, accurate results in a quick and cost-effective manner.
Company: Medgenesis Ltd.
Software Package
Name Version: TARA
Date of Certification:
December 17th, 2012
Link: www.tarapv.com
Description:
Tools for Adverse Reaction Assessment (TARA) is a pharmacovigilance software tool, which provides companies with the facility to monitor products and devices, providing early identifications of risks and safety trends. The solution is being used in clinical safety management for both clinical trials and marketed products. The core design of TARA is consistently
simple, intuitive and most importantly user friendly. TARA’s features have allowed dramatic improvements to the quality and speed of case processing, whilst ensuring data integrity. TARA has been designed from the outset by pharmacovigilance professionals, supported by a team of software developers drawn from both academia and the Information Technology Industry.
Company: DSG, Inc.
Software Package Name
Version: eCaseLink v 8
Date of Certification:
March 14th, 2013
Link: www.dsg-us.com
Description:
DSG, Inc. supports clinical trial data collection and management with innovative and fully integrated technology solutions, including Electronic Data Capture with specialized Clinical Data Management services, IWRS, Clinical Trial Management
Systems, Safety Tracking, and Protocol Violations software. Within eCaseLink™ edc is a fully integrated encoder supporting all versions of WHO drug and MedDRA dictionaries for Adverse Events, ConMeds, and Medical Histories, with all coding work conducted within one screen without need for additional system navigation. This allows real-time exporting of encoded data into SAS datasets and transport files as needed.
Company: Cisys LifeSciences
Software Package
Name Version: Sequence WebCode
Date of Certification: April 11, 2013
Link:www.cisys.com
Description:
Sequence WebCode is a web-based multi-dictionary medical coding system that features a robust search engine with auto-coding capabilities. Integrating Sequence WebCode with the Sequence WebEDC Platform provides a turnkey solution that offers superior value in support of your clinical trials. Highly configurable and standards based, Sequence WebCode can also be easily integrated with other EDC systems.
Features:
• Intuitive user-friendly interface
• WHO DDE and MedDRA Coding
• Dictionary management system with version migration
• Auto-Coding capabilities with intuitive approval workflow
• Customizable Synonym Lists with extensive integration features for both auto-coding and manual coding
• Multilevel ATC coding
• Search by drug name, drug code, ingredient, ATC, preferred, generic, or trade
• Highly configurable, standards based
• API and web services based integration with external EDC platforms
• Browser agnostic