Better Decisions. Faster To Market.
It's All About The Data...

IDENTIFICA is dedicated to the accuracy and reliability of data, and cohesive processes between industry and regulators globally.

You can create, edit, process documents with the highest degree of confidence with minimal to zero disruption to your current business processes and procedures.

About Us

We are IDENTIFICA powered by Pragmatic Data, passionate about transforming your data into business results. IDENTIFICA is dedicated to the creation, versioning, validation, and overall management of data. From point of creation to systems of record, ID offers a comprehensive and non-invasive approach for fit for purpose data utility for efficient and effective decision making across the value chain.

Our services are meant to solve a practical problem and when the problem is addressed, our clients and we are happy (all too often big software systems get in the way of the data.) Secondly, our name means pragmatics-oriented, that is, pertaining to the purpose of your data for your business processes.

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Pragmatics is the study of the purpose of information, i.e., meaning in the world of action. It is the 4th and highest level of the study of the form and meaning of information:

  • Lexical level - pertaining to the basic symbols, words and their forms.
  • Syntax - pertaining to the structure (e.g., sentences) in which words occur.
  • Semantics - pertaining to the meaning of the structures of words.
  • Pragmatics - pertaining to the purpose of meaningful structures of words.

Thus, we understand data on all 4 levels. For example, we understand terminologies and ontologies and we can find words in texts or translate between vocabularies. We also understand parsers and we can extract information from natural language or manipulate formal language. We can process higher level meaning based on ontologies and data structures. But ultimately we understand that terminology, form, meaning of data is there for a purpose, data is communicated and stored to facilitate workflow, to make something good happen in the real world. Pragmatics is the ultimate benchmark for all data management tasks. Our focus on pragmatics means that we get the task at hand done more expediently because we keep the purpose in mind.

Our Mission

We are experts and thought leaders in health informatics and international data standards for medicinal products. Our data management solutions have supported the world’s most high quality drug knowledge base managed cooperatively by industry and regulator (USA). We believe that data from authoritative sources are more reliable and up to date when properly managed with technology than even the most sophisticated secondary clean up efforts can accomplish.

We have enabled visionary senior executives and leaders in making significant impacts on data integrity and quality for both, manufacturing, regulatory, clinical, and distribution chain processes. If you are a visionary leader of your organization, we can propel you toward your business goals through better data. Our ID LIfecycle software is a nimble document and system-oriented platform that brings to life semantic content though terminology and semantic NLP, and structured authoring techniques. The scope and depth of data structuring is pragmatically oriented to your business process realities.

Data remains tied to the source through the chain of transformations, submissions, and down-stream use. With 30 years deep experience in biomedical data management we have seen many "magic bullets" that failed to deliver as represented. The pragmatic difference is that we have the vision and domain expertise to deliver; we want to get you to executing your visionary goals, one pragmatic and successful step at a time.

Services

Strategy, Intelligence, And Optimization Services

We ​provide thorough data management assessments, intelligence, and solutions to optimize your data and process strategies for improved business efficiency and more effective decision making from concept to execution.

Data Standards/Data Governance
  • Is having Command and Control of your data important to you?
  • Do you care if your data is validated, versioned, and reliable?
  • Not sure where to find your data?

We provide validation and life-cycle management services, ensuring quality and integrity of your data.

Health-Level-7 (HL7)

Dr. Schadow, has been chiefly designing the Health-Level-7 (HL7) standard Reference Information Model, an object-model that addresses of hundreds of complex use cases of biomedical data and workflow management.

  • The HL7 Reference Information model was constructed as a high-level generic UML object model representing physical Entities (people, places, things) which can play different Roles with respect to different scopes (e.g., person – patient of a hospital, person – subject of a trial, chemical – ingredient in a drug, anatomical part – structure, compound – moiety, etc.)See figure.
  • What makes the HL7 RIM relevant for ontology design is that, in addition to expressions over particular instances, the RIM also allows writing expressions over universals (Figure 2). One can describe Acts in general, mention preconditions, risks and outcomes in general, and speak of Entity universals (determiner = KIND)See figure.
Subject Matter Areas Of Experience

IDENTIFICA’s team of Subject Matter Experts provides in-depth knowledge sharing of Health Authority (HA) requirements. This information is derived from the ongoing interactions with global HA’s, experience from both regulatory and industry activities, and ongoing thought-leadership within the Life Sciences communities.

  • ​Identification of Medicinal Products (IDMP) Intelligence
  • HL7 Structured Product Labeling (SPL)
  • Drug Supply Chain Initiatives
    • Falsified Medicines
    • Lot Distribution/Serialization​
    • Product to Organization Identification​
  • Individual Case Safety Reports (ICSR)​
  • Unique Device Identification (UDI)
    • Combination Products​
  • Structured Document Format (SDF)​
  • Medicinal Product Data Dictionary
    • World Health Organisation (WHO) Data Dictionary Management
  • Quality and Manufacturing Data Integrity (CMC)
Software Development

We can deliver even larger software projects on short notice. We have strategic partnerships with software development firms which allows us to scale up developer quickly as needed while never loosing our unique focus on your data its purpose for your business.

Sometimes many hands are needed to deliver custom software to our clients. Identifica can deliver software solutions on short notice thanks to our strategic partnerships with software developers both locally and overseas.

While we can deliver these solutions and we are ready for the phases of the project where large scale custom development is required, we continue to keep our data-centric orientation. This is why our products are more intelligent and light weight than what others deliver who take a software-program focus.

We believe in data and business functions (pragmatics again) with the minimum necessary architectural complexity, the minimum number of lines of code. For our clients this means less baggage to maintain and often more flexibility.

Technology

IDENTIFICA is purposefully built for validation, versioning, and management of all types of data and formats (i.e., structured and unstructured) utilizing robust internal business rules and regulatory requirements

Machine Learning

The ID Lifecycle™ Direct Editor is (i.e., Structured Content Authoring) allows for freestyle editing and coding of SDF files on fully configurable stylesheets to identified terminology sets automatically.

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Design

ID-LifeCycle™ Powered by Pragmatic Data is a robust G-PLDM™ (Global Product Lifecycle Data Management) Solution.

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Data Integrity

SPL file will be checked both against the W3C XML Schema and against the extensive validation rules.

Blockchain Principles

The system supports data traceability to show how data is referred from one file to another. It is achieved using unique document IDs that are given to each document that are uploaded in the system

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Value Proportion

Dramatically reduce the costs of adding support for future requirements and interfaces.

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Request for Information/Proposal (RFI/RFP) Submission Portal

The RFI/RFP Submission Portal will support every file type (e.g., pdf, doc, docx, png, jpg, jpeg, gif, csv, xls, zip, mp3).