Electronic Data Collection (EDC) | Patient (EDC) | Genetic Variants | Big Data | AI | The CRID | Proof | Charts | ETL
CLIRINX EDC (Electronic Data Collection) provides a suite of software products to support web-based data collection on your clinical research study. It consists of a clinical trials management system (CTMS), a CRF/Form Designer for electronic data collection (EDC) and an electronic patient portal (ePRO).
The web-based CRF/Forms Designer is probably the most sophisticated forms designer available. It caters for the typical question types, and
also has novel question types, like table-based questions (combination of text/radio/dropdown/checkbox/likert field questions in multiple fixed
or dynamic rows), image mark, file upload and EEG node selection. Branching/skip rules can be implemented on individual questions,
groups of questions and fields within table-based questions. And if you need a new feature or application, we can develop it for you!
CLIRINX Patient Portal (ePRO/EDC) is a separate website that study participants (parents and patients) access to contribute data to the research study. It is extremely easy to use and requires no training. It allows parents/patients to complete data collection forms, download their own data and view newsletters and summary stats on the data collected. It also facilitates diary-based data collection (daily, weekly or monthly), such as medication usage, seizures, moods, etc.
The system supports multiple research studies and each research study can have its own specific URL website address. You can create a login account to access the website or login using an existing account.
When you select a study for the first time, you are asked to complete the Informed Consent process (using digital signatures) for a specific study. For users in the EU/EEA, an additional consent is required to support GDPR requirements.
Once the e-consent process is complete, the data collection forms are made available.
The system supports data collection at multiple timepoints and multiple patients, and the user can access their own data in reports (e.g. PDF) and structured formats (e.g. CSV, JSON). The system is also integrated with CRID™ so
that data can be shared, if desired, with other external research projects and PIs.
VarTracker is an online tool for searching multiple public genetic variant databases, displaying genetic variant
information merged from a variety of sources and alerting you when new information is available.
The end-user can search for variants of interest based on a RefSeq ID and a cDNA change, and the tool will search and extract data
from a variety of public databases, such as ClinVar, NCBI Gene,
UniProt, dbSNP, NCBI Books, PubMed, MalaCard, MyVariant, gnomAD, ExAC, Mutalyze and ENSEMBL.
The system will then re-check these variants regularly to see if any variant information has changed, and will alert you when there is new information available.
We are experts at developing and using interfaces to common health informatics databases, and these are already integrated into the CLIRINX software. Interfaces include C-CDA (EPR), dbSNP, Sequence Ontology, gnomAD/ExAC, PubMed, SNOMED-CT, ClinVar, Ensembl, CTCAE, MyGene, MyVariant, RxNorm, Human Phenome Ontology, and many more.
Big data is concerned with the data management challenges that can't be solved with traditional databases and servers. Volumes range from terabytes to petabytes of data, can be of any type
(e.g. genomics data, EEGs, MRIs, etc.), and needs to be stored, made available and processed within relatively short time-frames. CLIRINX can help your organization design and implement
a robust big data strategy to help reduce costs and gain operational efficiencies by migrating huge data and heavy workloads to Amazon AWS.
CLIRINX provides sophisticated Artificial Intelligence (AI) tools for clinical research. These include expert systems, intelligent knowledge bases, NLP and machine learning (Rubix ML).
AI tools are computer applications that combine software and specialized information to imitate expert human reasoning and advice.
Expert systems can be used to help with decision-making and solve complex problems in medical research.
The intelligent knowledge base (KB) editor allows you to define and store complex structured and unstructured information about a specific area of knowledge, called a knowledge domain.
Whereas the expert system defines knowledge in terms of if-then rules, the knowledge base editor provides a curation tool where knowledge can be defined in terms of a hierarchy, attributes and facts.
The Clinical Research ID (aka The CRID™) is a service that enables patients involved in clinical research studies the opportunity to create their own unique identifier to be used in clinical research.
This identifier (aka. The CRID) can be used across multiple clinical research studies and will allow researchers share your clinical data (not PII/PHI) with other research studies you are involved in.
Think of it like a SSN without the need to share your private information. You can see a list of studies you or your children are enrolled in, when you enrolled in the study and what your Patient ID is on each study.
Researchers can validate CRIDs to make sure they're correct, and external clinical research IT systems can use the API to search and retrieve a patient's CRID or generate a new CRID if required.
Potential benefits include:
• Allows datasets from different studies to be merged.
• The research study PI can request specific data from patients.
• The patient can share their medical data (CDE, medical records, genetics reports, etc.) securely with research studies.
• Patient has visibility into research studies they're enrolled in.
• Patients can receive alerts about new relevent studies.
• Approved research studies can interface with The CRID using secure APIs.
• Approved research studies can send the patient's research data back to the patient.
The CRID SSO™ provides a simple solution to single sign-on using RestFUL API services.
This service is primarily for patients/parents who are involved in clinical research and researchers at institutions who conduct research.
The patient can use their CRID SSO account to login to any institution's research system, eliminating the need to remember multiple login credentials.
CRID SSO is used by the CRID Unique Patient ID system. Now a patient has one ID that follows them across different research studies and one login/password to access multiple research systems. And researchers now have one login/password that allows them use research systems across institutions.
The client application will redirect the end-user to the CRID SSO Login page to allow the user input their username and password, and complete two-factor authentication, if required. After successful authentication, the user is returned to the client application. A user can also be authenticated using the RestFUL API only, without the need to use the CRID Login screen. End-users manage their own credentials using the CRID SSO website. Application providers and research institutions can register to include CRID SSO in their research applications.
CX Proof™ is a REST API web service that allows you to record simple digital signature metadata in a ledger-like database and across multiple blockchains.
It allows you to store 2 variables, for example, a Record GUID and a Document HASH key, in a secure database.
A hash key is then generated of the timestamp and the variables to ensure the record can't be altered. Some of the methods available are validate token, check service status, retrieve record(s) and save record.
Updating existing records is not possible and a full audit log is maintained. It will also store the hash key across 3 separate blockchains (Bitcoin, Ethereum and Aion).
The CLIRINX EDC system makes use of this service for storing metadata on digitally signed study documents, patient informed consents and GDPR consents. CX Proof™ provides a way of storing digital signature metadata on a server separate from the customer's CLIRINX server. No patient PHI data is ever stored on the CX Proof™ server.
CX Charts™ provides features to generate milestone charts, timelines and graphs from patient data. These can be used to provide visual feedback to patients enrolled on your study
and can be embedded in the patient portal. The milestone charts show notable medical events, such as doctor/specialist visits, hospital/ER visits, EEGs/MRIs and changes in the status of a disease.
The timeline charts can be used to illustrate patient disease phenotypes, medications and other conditions. Graphs (bar charts, line charts and pie charts) can be used to illustrate other types of quantitative data.
This tool will transform any data in CSV format into a data dictionary, SQL create table/insert scripts, CSV output file or a CLIRINX (or RedCap) data dictionary and import file. You can perform operations like
convert field values (e.g. change 'YES' to '01' is a specific field), split composite fields into separate fields, drop fields and merge fields.
CLIRINX provides core IT expertise to academic medical research studies, including custom software development, informatics strategy and data management.
We help clients achieve their goals in medical research by providing a range of informatics and support expertise to simplify the research process
and deliver client projects on time while maintaining the highest quality standards.
Expertise we provide include Project Management, Software Development, Training, Informatics Strategy, Data Migration, Neuroimaging Processing, Medical Record Processing and RedCap Consultancy.
We are PMP certified by the Project Management Institute (PMI), and have years of experience managing complex IT projects across a broad range of industries. We are experts in a variety of PM methodologies, including waterfall and agile software development (and different flavors in-between). When it comes to managing your IT projects, we're considered the "safe pair of hands" to make sure your project succeeds spectacularly.
© CLIRINX Ltd.
T: USA +1 (412) 5671172 / EU +353-86-418 6512 / Australia +61 3 9028 7373 E: email@example.com W: https://www.clirinx.com