CLIRINX Electronic Data CollectionCLIRINX 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 participant 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 PortalCLIRINX Participant Portal (ePRO/EDC) is a separate website that study participants access to contribute data to the research study. It is extremely easy to use and requires no training. It allows participants 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 participants, 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.
Genetic Variant TrackerVarTracker 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.
Big DataBig 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.
External API InterfacesWe 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.
Artificial IntelligenceCLIRINX 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 academic 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 CRIDThe Clinical Research ID (aka The CRID™) is a service that enables patients and parents (and their child/children) involved in clinical research studies the opportunity to create their own unique universal patient identifier to be used in clinical research. This CRID identifier 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. Researchers can validate a CRID to make sure it's valid, and external research IT systems access features through a RESTful API interface. The main benefit is that more of your research data can be shared between researchers and data silos can be eliminated.
ProofCX 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, participant 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 participant PHI data is ever stored on the CX Proof™ server.