STUDY CONDUCT SDTM Mapper DATA MANAGEMENT Analysis & Reporting System BIO-STATISTICS CSRT Builder CLINICAL STUDY REPORT SUBMISSION 1. Define XML Generator 2. Validator 3. Reviewers Guide Builder CLINICAL DEVELOPMENT R A T I L A N

PRODUCTS

    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
    Smart aCRF
    • CRF Annotation
    Smart Mapper
    • SDTM Mapping (SDTM mapping or raw (source)data from EDC to standard data)
    Define.XML
    • Define XML generation
    Validator
    • CDISC SDTM validation
Minnal

CRF Annotation

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.

Benefits:
  • 60-80% reduction in typical manual annotations timeline
  • SMART Annotation Repository- A growing body of keywords and annotations(with attributes).
  • Easy integration of customs/sponsors metadata into database.
  • Reverse engineers existing annotated CRF to machines both keywords and annotations.
  • Integrated ML/NLP solution for keyword detection and prediction.
  • Removes SAS from the process reducing costs on expensive licensing
  • Smart aCRF
    Benefits:
  • SMART aCRF – A system to Automate CRF Annotation.
  • Annotation repository – A growing body of keywords annotation pairs – learns ,stores, facilitates Re-Use of annotations
  • Keywords, annotations and annotations attributes with location can be added or modified with ease and saved for Re-Use.
  • SMART Annotation Repository and learning augment repository as the applications is used in more studies.
  • Reverse Engineer using existing study annotations to augment repository and Re-Use.
  • Preloaded with CDISC/sponsor defined metadata & CDISC recommended text and annotation attributes.
  • CDISC SDTM Mapping

    Smart Mapper

    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.

    Benefits:
    1. 60-80% Reduction in typical manual annotation timeline
    2. Convert studies from raw data model to target SDTM
    3. Auto generates mapping specification for raw data to SDTM Transformation
    4. Provide input to SAS Program for Regeneration of dataset for target model
    5. Integrated ML/NLP solution for keyword detection and prediction

    Define.xml Module

    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.

    Define R3
    Reviewers Guide:
    • 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.

    VALIDATOR

    Smart aCRF

    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

    About Ratilan

    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.

    About

    Our Team

    Ilango Ramanujam
    President & CEO

    Ilango, A Passionate Life Sciences Entrepreneur. Has over two decades of experience in Pharmaceutical, Bio-tech and CRO industry. Conceptualised and designed products to manage clinical data from collection to submission. Created and Built – Development and Services Teams – globally which delivered several regulatory critical systems in Clinical Data Sciences, with uncompromised quality to Pharmaceutical companies.

    President & CEO

    Ilango Ramanujam
    Asokumar V
    CTO

    Asok is responsible for designing and building high performance and data centric product lines at Ratilan. He has been the driving force behind Ratilan’s MINNAL product suite, an innovative cloud based clinical data standard automation platform .
    He has rich experience of over 25 years in Realtime event processing, EAI/SOA technologies, Big data analytics. He has been part of a team that developed and delivered transformational IT strategies to large corporations across North America.
    Asok holds a Computer Science Engineering degree from Institute of Road and Transport Technology, India.

    CTO

    Asokumar V
    Vasanthakumar L
    Architect

    Vasanth is a Life Sciences Expert with over 15 years of experience in building products and services. He started his career as a Statistical programmer and grew to manage Statistical Programming teams and has also designed multiple systems that manage Clinical Data. His experience includes successful NDA/sNDA submissions, proficiency in Phase I-IV Clinical Trials and therapeutic areas including Oncology.

    Architect

    Vasanthakumar L
    Senthilkumar K
    Principal SME

    Senthil, a Clinical Data Expert, adept at developing tools for Data Analysis & Reporting, Data Extraction, TLF Generation, Derived Data-set Creation, DDT Generation, Patient Profile, MedDRA Mapping, Lab std., and Submission File Generation. Has managed teams for large Pharma Companies for preparation and delivery of Submission Standards with proven excellence in managing Statistical Programming Activities for Data Summarization, Statistical Analysis and Reporting of Clinical Trials.

    Principal SME

    Senthilkumar K
    Eric Weising
    Principal SME

    Eric, With over 20 years of experience at Symbiance, is the Director of our Clinical Data Management Unit. By combining his critical thinking and problem-solving skills with his degree in Mathematics from Kean University, Eric has accumulated experience in Phases I-IV (with particular expertise in Phases II and III) and has substantial experience in such therapeutic areas as oncology, pain management, Alzeheimer’s disease, depression/anxiety, epilepsy and hypertension. Eric’s responsibilities have run the gamut from performing quality assurance of outputs (TLF) and SAS programming to clinical data management and biostatistical analysis.

    Principal SME

    Eric Weising
    Raja Vadivel
    Head of Business Development

    Raja is a Life Sciences Expert with over 20 years of experience in building products and services. He started his career as a Statistical programmer and grew to manage Statistical Programming teams and has also designed multiple systems that manage Clinical Data. His experience includes successful NDA/sNDA submissions, proficiency in Phase I-IV Clinical Trials and therapeutic areas including Oncology, Neuroscience, Respiratory, Cardiovascular, Genito-urinary, Vaccine etc. He has worked with CRO’s and multiple pharma/biotech companies like Eli Lilly, Bayer, BMS, Pfizer, ICON, RHO, Gilead, GSK and Novartis.

    Head of Business Development

    Raja Vadivel

    RESOURCES

    Thank you for your interest in our Resources. Our White papers and other resources are currently being updated. Please contact us for more info.

    Contact US

    Contact Us

    US Address

    • 51 Everett Dr, Suite B-20, Princeton Jct, NJ-08550.
    • Phone: +1 609 243 9050

     

    India Address

    • Rayala Techno Park, 2nd Floor, 144/7 Rajiv Gandhi Salai, OMR, Kottivakkam, Chennai – 600 041, INDIA
    • Phone: +91 44 4009 8500