It’s off-the-shelf, you can start right away!
Imagine if all your study content – standards, forms, datasets, mappings… were in 1 place. And they were all interconnected. Everything from eCRFs to submission deliverables. No matter where they were, your teams could manage standards and studies, share and reuse content – even across different EDCs and e-clinical systems. That’s Formedix. The all-in-1 fully integrated clinical metadata repository. And you can start now. It’s ready out-the-box – no long and complex implementation.
Creating clinical study builds from scratch is far quicker and easier with our clinical metadata management software. You’ve got pre-approved, consistent content in your clinical metadata repository. And this can be reused forevermore across your studies and standards. Instead of starting out with nothing, you’ve got an entire library of content ready to go!
Because your content is in 1 place, you don’t need to go hunting for it. Everything held in your studies and standards is right there for all to see. Different teams can get at the metadata they need, and easily share and approve content. Plus, you save acres of time reusing study metadata. There’s no need to retype file contents every single time!
Increase the quality of studies by reusing content from your standards library in our clinical metadata repository. You’re not constantly retyping stuff, so there’s no manual errors. And because you’re using standardized content, you know it’s already been approved internally.
By managing standards and building study libraries in our MDR platform, you really cut study build costs. You get started so much faster because most of your content is already there in your clinical metadata repository. And if the data you want isn’t there, just import it into your Formedix library from your EDC, e-clinical or internal systems!
The Formedix MDR platform incorporates a clinical metadata repository (MDR), or a cloud MDR! Think of it as a central library where all your clinical metadata is held and managed. All of your content is fully connected, from eCRFs through to submission deliverables. You can easily find, review, reuse, and share content – including across different EDC and other external systems.
1 home for your metadata
Different departments can access studies and organizational standards in one place for your MDR clinical trials. You can assign work to specific individuals, and allow parallel review by multiple specified users. This gives greater transparency and enables better communication amongst your team. Global search functionality makes it quick and easy to find studies, standards, and assets in your clinical metadata repository.
Easily manage changes
With our MDR automation platform, you can easily manage changes and consider impacts. You benefit from a structured process that adheres to regulatory compliance. And this, in turn, reduces associated risk. Find out more about change management in Formedix.
How our metadata management tools make things easier
You can create and manage your organizational standards in your clinical metadata repository. This includes importing content from your EDC, e-clinical database, or other external systems. This helps to increase your data quality and decreases downstream costs. By creating consistent forms and datasets, building studies from scratch is now quick and easy!
For studies and standards, you can include any related links. For example, you can link to a CDISC Therapeutic Area User Guide with instructions for how to use a CRF or dataset. You can also add any related files, such as the protocol or statistical analysis plan.
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 for your MDR clinical trials.
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.
You can quickly and easily build a study from a set of standards. First, create and approve your standards within a company defined governance workflow. You have complete control over your study designs.
Choose your forms and related datasets from your standards. All related metadata, such as edit checks and mappings, is brought in automatically with your standards, so you know they’re correct.
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 does not contain 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 generate your source Define.xml and ensure it meets the various regulatory requirements to help you achieve a hassle free submission. Mappings are part of the study design so you can generate initial downstream datasets – you don’t need to program the data conversion for your study!
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
We’re using the Formedix platform to design CDASH example CRFs for the CDISC CDASH-IG standards package. We can create, visualize, edit and approve eCRFs in the platform, then export them in ODM-XML to use in the CDISC Library and standards packages. Formedix is one of CDISC’s longest standing members. CDISC is keen to work with technology partners that help pharmaceutical organizations to adopt and keep pace with emerging CDISC standards.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities.
The pharmaceutical industry has been changing over the last 10 to 20 years. Things are moving from paper based clinical trials, to electronic data capture based clinical trials. There’s also a larger number of sponsors, trials and data than ever before to deal with. Industry standards have become an absolute necessity for governing and managing clinical trials. These are now required as part of the submission to regulatory bodies, such as the FDA.
As a result, clinical trials are facing increasing challenges, and spiralling costs. Clinical data repository software helps to address these challenges. Here’s 4 important things to think about when considering a clinical metadata repository.
Having a central web platform for managing standards and clinical metadata saves time and reduces manual labour. This ultimately helps reduce the cost of setting up and managing clinical studies. And using standards gives you plenty more benefits.
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 how the Formedix metadata lifecycle works.
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.
An off-the-shelf solution doesn’t always meet your needs. No problem. Our in-house development team has had a lot of practice at this. We can customize our clinical metadata repository and clinical trial automation software to work for you. Best to get in touch and tell us all about it.
Change during the clinical trial process is a painful, unavoidable reality. It is also essential for quality assurance. And we all know that change control that isn’t properly managed results in regulatory non-compliance.
Formedix takes away all that pain and allows you to manage changes confidently, knowing that nothing has been missed. Change request details are easy to find and review in Formedix. You can even download a summary of all change requests.
We give you complete flexibility. You can customize your own change request templates – each with their own workflow – which you can configure to suit your needs. Find out more about change requests.
Impact analysis tools in Formedix help you clearly see the impact of any proposed changes. You can also identify any associated assets that may need to be updated. Read more about impact analysis.
You can run reports that show the differences between your studies and organizational standards. And you can compare a study to your standards, or other studies, or previous versions. That way you have complete control over change.
Everyone knows that people achieve more working together in teams than they do alone. Our clinical metadata repository gives you total transparency throughout the end to end process. And this helps to improve the overall quality of your clinical trial data.
Formedix lets you set up role-based access to standards and studies. Standards can be available to all, or locked down to specific teams. Studies can be open to all, or restricted to a smaller study team. Plus, individual teams can have different access rights. For example, data managers may be able to edit forms and view datasets. Biostatisticians may be able to view forms and edit datasets and mappings. It’s really up to you how you want it to work!
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.
It’s the ability to update, manage and see all your clinical trial metadata and data standards. Formedix gives you the ability to stay compliant at all times. Processes are simplified and speeded up.
Clinical metadata refers to all the metadata you use in your clinical trials. Examples are datasets, controlled terminologies, forms, annotations and edit checks.
Yes. Using the Formedix clinical metadata repository means you have standardized content ready to use again and again across your studies and standards. It’s quick and easy to make updates. Once your happy, it’s a click of a button to create your clinical study build.
It’s a clinical web based management system where you can manage your organizations standardized content. You can also share and reuse clinical trial metadata.
To allow you to create and manage change requests, measure the impact of changes and have governance built in. They should also allow collaboration among teams and be able to integrate with other systems.
To be CDISC complaint, stay up to date with new standards and support older versions of standards. They should also allow reuse, have versioning, built in traceability and allow you to find metadata quickly and easily.