The Formedix Clinical Metadata Repository (MDR) is a centralised, all-in-one, fully integrated clinical metadata repository. You can get started straight away. It is off-the-shelf, so there is no need for complex implementation.
Formedix offers a Cloud-based, off-the-shelf clinical metadata repository and clinical trial automation software platform, which enables the prompt design, build and submission of clinical trials.
The company’s software facilitates time-consuming, expensive manual tasks, ranging from study set-up through to submission cutting costs of running trials, improving efficiency, compliance and data quality.
Clinical metadata repository
Formedix’s clinical metadata repository provides a central home to govern organisational standards, which users can manage, update, approve, and share in one place. This includes the importation of existing content such as standards, studies, forms, and datasets from electronic data capture (EDC) and e-clinical studies.
Through building standards libraries in a central clinical metadata repository, clients can easily reuse standardised content across all studies and standards, saving time and resources.
Formedix’s clinical metadata repository includes all features required for impact analysis, change request management, and governance, ensuring a company’s workforce can work together seamlessly and collaboratively.
For help in automating study design and build, Formedix’s clinical trial automation tools use content in companies’ existing clinical metadata repository to create studies promptly.
Clinical trial automation
For the development of electronic case report forms (eCRFs), the building of EDCs, the design or conversion of datasets or creating define files, Formedix aids in these processes in a little amount of time.
With the software, users can quickly make study CRF designs and EDC designs from standardised content. The company’s visualisation tool enables users to see what forms will look like and how they work during the design process.
Users can make annotated compliant study data tabulation model (SDTM) datasets and analysis dataset model (ADaM) datasets using Formedix’s templates. The company keeps up-to-date with the latest Clinical Data Interchange Standards Consortium (CDISC) standards, but users can also work with older versions.
Operators can receive submissions using Formedix’s visual define.xml editor, as well as generate define.xml files from statistical analysis software (SAS) Xport transport (XPT) files or old legacy datasets.
Formedix fully integrates with Rave. Users can integrate with seven leading EDCs, as well as personal internal systems using the company’s application programming interface (API), enabling the set-up of automated processes to push data into Formedix and trigger a conversation, pulling datasets back onto the system.
The company complies with regulatory requirements; operators can use Formedix’s validation tools to check CRF and EDC designs, as well as built-in CDISC validations.
CDISC standards compliance
Built on CDISC standards, Formedix’s platform is routinely updated in-line with the relevant standards, and both current and previous versions of CDISC are supported.
The company is on the CDISC Extensible Markup Language (XML) team, involved in creating CDISC operational data model (ODM) and Define models, working with CDISC for more than two decades.
Services and training
As experts in the end-to-end system, Formedix’s professional services team is available to support all clients, offering day-to-day support and helping clients to achieve company objectives.
Formedix also offers training tailored to suit each individual, providing sessions on-site, as well as remotely via webinars, depending on what satisfies each organisation best.
Annotating CRFs (Case Report Forms) is an important but almighty task. You need to manually create annotations for every single form, then convert your forms into PDF, which is a lot of time and resources.
Formedix provides a Cloud-based, off-the-shelf clinical metadata repository and clinical trial automation software platform for the prompt design, build and submission of clinical trials.
Clinical trial software is used by CROs, biotechnology, and pharmaceutical companies to facilitate clinical trials from conception to finish. For example protocol management, CRF design, metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities.
The Clinical Data Interchange Standards Consortium is an organisation dedicated to helping to improve medical research by driving communication through data standardisation.
Many companies in the life sciences industry are slow to adopt new technologies due to complex regulatory requirements. However, there’s been a lot of advancement in new and emerging technologies in recent years. The US FDA has recognised the benefits and is supportive of their use.
As you know, clinical trials are complex! Industry standards are now required for clinical trial submission. And that means even greater complexity, costs, resources, time and effort.
When it comes to clinical trial submission, one of the most significant standards is the Analysis Data Model (ADaM), as it describes how to build analysis datasets and associated metadata.
Most individuals’ first introduction to CDISC is typically through the use of Study Data Tabulation Model (SDTM).
Metadata comes from multiple sources and can be stored in different places, systems and networks. It’s hard to track it down. When files are updated, new versions are created. So how do you know if you’ve got the latest version? How do you know if the quality is good enough?
Define.xml is the metadata that describes the content and formatting of submission datasets and the case report tabulation data. It’s needed to help reviewers understand the data they are reviewing.
Annotated CRFs document the location in a database of the data collected for each question on a form. It is a mapping between each item on a form to its corresponding variable contained within the corresponding dataset.
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