Automatically align with CDISC standards, with our off-the-shelf MDR.
Formedix makes it really easy to manage your clinical metadata. Rather than searching for standards and study content in different files and spreadsheets, easily find everything in your clinical metadata repository. All your standards are in 1 place, for all your teams to see. It’s like having a really clever library!
Need to update your standards over time? Make changes with full traceability in Formedix. Track amends and see how your study differs from your standards – in 1 place, with 1 click! And because your standards go through quality approvals in Formedix, you know that you’re consistently using approved content.
Probably your biggest benefit is time saved. Because everything is in 1 place. It’s easy to find, use, and reuse. There’s no need to redesign CRFs, edit checks, terminologies, and mappings for example every time. Design once and reuse content across your studies and standards – even across different EDCs.
Do you work with any of these standards or systems? Formedix integrates with all of these, and can look at others if that’s what you need:
CDISC ODM, Define-XML, Analysis Results Metadata and Dataset-XML file format standards
CDISC SDTM, ADaM, SEND content standards
SAS Transport v5 (XPT)
EDCs including Medidata Rave, Oracle InForm, OmniComm TrialMaster, XClinical Marvin, OpenClinica, PAREXEL DataLabs and Mi-Co Mi-Forms
You can quickly and easily build a study from a set of standards. First, create and approve your organizational standards in line with your internal processes.
Select your forms and related datasets from your standards. All related metadata, such as edit checks and mappings, is brought in automatically with your standards. Add any relevant protocol information – such as the visit schedule, custom edit checks, or custom mappings.
Then use our visualization tool to see what your CRFs look like in your chosen EDC system.
Once you’re done, you can carry out validation checks to make sure your study doesn’t have any errors, or is missing any metadata.
You can export it to your chosen EDC system, confident that it will work – you know the study is exactly as you designed! You can also create your source Define.xml and ensure that it meets the various regulatory requirements to help you achieve hassle free submission. Mappings are part of the study design, so you can generate initial downstream datasets. That means you don’t need to program the data conversion for your study!
A standard is simply a group of related assets such as a forms, edit checks, datasets, mappings and terminologies. Your company can decide how best to group assets, for example, a standard could contain a Medical History form and a Medical History dataset or, it could contain multiple forms or multiple datasets.
You can design and refine standards according to your company’s governance process. Once approved, it becomes an organizational standard. If assets are standardized across the clinical lifecycle, you can be certain that data collection is consistent and valid, right through to submission.
Your approved standards can be reused. That means you only need to create them once! Study setup time is dramatically reduced by importing standard metadata from one location to another. So your process is very efficient as the content has already been tested and validated. Mapping to downstream systems is consistent, and there’s now a much smaller chance of mistakes happening.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities. ...
We love what we do, love our community, and seeing the difference we make for people in the industry.
We’re always adding new stuff – mostly from your feedback. And our product road map promises lots more features to come.
You need us to be honest and clear, and that’s exactly how we are. We do what we say, and if we can’t do something, we’ll tell you.
We genuinely care about you succeeding, and we’re on your side – think of us as an extension of your team.
We get on with things and get them done, no messing. And we’re fast, so you get more done, faster, and get a quick ROI.
Formedix has developed standards management libraries for leading life science organizations. And not just regular standards libraries or repositories. We’re talking about standards libraries specifically optimized for clinical trials – to help deliver clinical trials as quickly and efficiently as possible.
You can define and validate your clinical metadata upfront in a standards library. This means you can control your metadata right from the outset. And in the end you’ll be able to improve consistency and data quality.
Formedix supports the latest industry standards such as CDISC SDTM, ADaM and Define-XML. So you can relax knowing that your studies meet the requirements of regulators such as the FDA, PMDA and EMA.
Formedix lets you import content from standards or existing studies, and make use of eCRF designs in Medidata Rave and Oracle InForm for example. Just move content from one location to another as you like.
You can see EDC specific CRF designs, and instantly make EDC build files for many different EDCs. All you do is switch on a plugin! You can also create detailed specifications and generate annotated CRFs in 1 click.
You can reuse study designs again and again. So once they’re designed that’s it! With standardized study designs you can build studies fast, knowing they’re consistent and correct. Data quality is increased as there’s less chance of collecting the wrong data, or collecting too much data.
You can evaluate the impact of any changes you want to make. Formedix shows you all the associated standards and standard assets that may also need to be updated. Read more about impact analysis.
Formedix has a user friendly interface with a search function that lets you search across all your standards quickly and easily. There is no longer any need to trawl through different documents, stored in different locations.
Traceability is becoming increasingly important during the lifecycle process allowing transparency between team members. Formedix allows you to easily see a full and detailed history of a standard – a single version of truth! If any questions come up about a particular standard, they can be quickly and easily answered!
You can set up a lifecycle for your standards to transition through according to your company’s governance process. By promoting good practice you can increase the quality and consistency of the data you gather. Read about the metadata lifecycle.
Governance and change is key to the evolution of your organizational standards to make them more robust which leads to safer, more effective clinical trials.