MINNAL Clinical data standard solution
Minnal is a platform to Standardize Clinical data(CDISC SDTM) and to prepare (Define.xml, Validator and reviewers guide) clinical data for regulatory agency submission. It has functionalities such as CRF Annotation, generate database specification ,SDTM mapping & produce SDTM datasets, validate SDTM data with FDA/PDMA rules, produce define.xml & reviewers guide.
Minnal leverages Machine Learning & Natural language processing techniques.
Minnal brings efficiency to clinical data life Cycle.
The Minnal suite has 4 modules
- CRF Annotation
- SDTM Mapping (SDTM mapping or raw (source)data from EDC to standard data)
- Define XML generation
- CDISC SDTM validation
CRF Annotation is manual and time consuming – SMART aCRF reduces the manual effort in CRF Annotation with Automation. Annotation efforts are not either customized and repeated. SMART Annotation Repository – A growing body of keywords and annotations pairs (learns, stores and facilitates Re-Use of annotations). Keyword, Annotations and Annotation attributes with Location can be added or modified with ease and saved for Re-Use. Smart learning within the application and repeat usage augment the repository as the application is used. Comes preloaded with CDISC/Sponsor defined Metadata, the recommended Text and Annotation attributes.
CDISC SDTM Mapping
SDTM mapper uses CRF Annotation to CDISC variables. The result output of Smart CRF module is an annotated CRF and SDTM metadata (Target Metadata) for a study. SDTM mapper prepares target SDTM data model for each Domain in the study by adding “Assigned Variables” (e.g. STUDYID), “Calculated variables” (e.g. AGE) and looks all permissible variables to generate target metadata based on the version selected. Source metadata from EDC is compared against target metadata (SDTM) for each variable, Label etc. and create the mapping specification.
- 60-80% Reduction in typical manual annotation timeline
- Convert studies from raw data model to target SDTM
- Auto generates mapping specification for raw data to SDTM Transformation
- Provide input to SAS Program for Regeneration of dataset for target model
- Integrated ML/NLP solution for keyword detection and prediction
Pre-loaded with the CDISC Metadata and Control Terminologies. Supports single user and multi user environments with connectivity to a variety of databases Create Study/Upload XPT’s & Annotated CRF/Process/View as Define XML – in minutes. Reverse Engineer Define XML from related studies for conversion into Study Metadata. Progressively Add XPT’s/Edit Study Metadata/Edit Exception Report and view in Define XML specification format. View and Edit all Exceptions in place in UI View/Edit all levels of the Study Metadata – Domain, Variable, Value, Where Clause, Code list, External Code list, Computation Methods and Reference Docs in place Export the Study Metadata as Excel and Re-Import with changes/corrections Configurable to User requirements.
- Pre-defined or Customized template for your Study or Submission data
- Accurate justifications – noted from Data Issues items
- Auto adjustment for linking and formatting in a final document.
The Validator module of the product: SDTM data compliance and Accelerate review with FDA/PMDA. Two levels check the first is Data Aptness in which data will be performed, before submission process begins. To avoid the major deviations at last-minute. The next level compliance confirmation Checks to ensure the Standards Compliance to make the data as “Ready for Review “Data Review rules – Rules to safeguard the quality of the data (in addition to regular standard compliance checks) cross domain checks rules to streamlines the quality of the data across the domain. The rules are customized.
SERVICES WE OFFER
IT Services using ML/NLP & Data Science:
Building innovative products using ML/NLP for customers. We can rapidly put together a team of Data Scientists, and ML/NLP specialists. We build innovative products/solutions for customers using Machine learning and natural language processing in any industries. We can rapidly put together a team from our existing pool of ML/NLP experts and data Scientists.
Typical engagement structure:
- Ratilan will source suitable personnel ahead of requirements with a good understanding of engagement timelines.
- All resources will be clearly tagged for function.
- Customer will directly engage Ratilan resources for any development in the Platform Build Track and perform the Project Management activity.
- Resources can be engaged in the USA and India
- The following are the resources available for an engagement. Solution Architect, Program Manager, Project Manager, Data Scientist, Developer, Test Lead, release manager, build manager and support engineer
We are a technology firm with multiple years of experience in the Pharmaceutical IT industry building products using ML/NLP techniques. Our products are backed by inputs from the industry experts and our In-House SME’s and over two decades of experience in the area of clinical data standards/analysis and regulatory submission.
Our primary goal is to bring Technology to Life Sciences SMEs and Life Sciences to Technology Experts and automate Customer needs to the highest Satisfaction.
Thank you for your interest in our Resources. Our White papers and other resources are currently being updated. Please contact us for more info.
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