Tools and Technologies used in eCTD submission

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Common Technical Document is defined as a set of specifications which is used for making any application for registration of medicines. This system is used across US,EU and Japan Australia etc. CTD is maintained by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The main purpose of this Document set is to combine all safety, efficacy and quality data which are required for regulatory review process by Authorities ultimately for approval of drug registration.

            As we are in 2020, The hard copy of documents are not practical in majority countries. All the submissions to the Regulatory Authority shall be done through various eCTD software's online. The harmonized CTD specifications are given by ICH guidelines ( Multidisciplinary guidelines M4).

                   The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, life cycle management and archiving of the electronic submission.The eCTD specification lists the criteria that will make an electronic submission technically valid. One can view an eCTD submission with a Web browser as it is Web ready. 

  Various tools used are as follows:-

TOOLS

DESCRIPTION

BENEFITS OF REVIEW TOOLS

JMP

Statistical software program that allows the reviewers to easily open data files (e.g.,. xpt,xls), view data, perform analyses, and generate graphs

 

#) Can ingest and analyze non- standardized and standardized data

#)Easy to share analyses with others if they have an account

 

JMP Clinical

Desktop application that offers data discovery, analysis and reporting for pre-clinical, clinical and post-market data

 

#)Can combine data-sets across the application to gives a more integrated view of the submission data

#)Reviewers like the graphic patient profiles to view data across all domains on a timeline

 

JReview

 

Web-based review tool that allows users to tabulate, visualize, and analyse safety and efficacy data

 

#)Can ingest and analyse no standardized and standardized data

#)Can share analyses with other users that have accounts

#)Reviewers like the graphic patient profiles to view data across all domains on a timeline

#)Standard analysis catalog for clinical review continues to expand

 

MedDRA-Based Adverse Events Diagnostics (MAED)

 

Performs a series of exploratory adverse event analyses on data from clinical trials.

 

#) Can use standardized and no standardized data

#)Provides the ability to perform custom queries

 

Statistical Analysis Software (SAS), including SAS Analysis Panels

 

SAS - software suite developed by the SAS Institute for advanced analytics

SAS Analysis Panels – scripts developed to perform standard analyses for clinical reviewers.

 

MedDRA at a Glance output provides a look at the MedDRA hierarchy in a way that no other tool can currently

 

Janus Non-clinical

 

Enables visualization and analytics for the toxicology studies (e.g., general toxicology and carcinogenicity studies)

 

Provides visual representation of the non-clinical study reports.

 

Some of the software's which are employed in eCTD submissions are:

1.Lorenz
2. eCTDoffice
3.MasterControl
4. PharmaREADY
5. Extedo (USA) IABG LSS 
6. Dataform Image Solutions
7. MedXView
8. TAKE Solutions
9. Thomson Liquent


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