As you know, clinical trials are complex! Industry standards are now required for clinical trial...
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.
Running clinical trials costs a lot of money! Despite that, there’s no guarantee of success. Many clinical trials fail and there are many reasons why. For example, badly designed forms can result in incomplete data being collected. There’s a huge amount of complex data to deal with. The list goes on.
The time it takes to get a product to the market is critical for companies. Each extra day amounts to much greater costs and a loss of competitive advantage. Automation can mean the difference between failure and success!
What is meant by automating clinical trials?
Automation is used to simplify and streamline processes and to improve the accuracy of results in the clinical trial process, from study setup through to submission. It also makes it easier to comply with the standards required by regulatory authorities, such as the FDA.
Five benefits of automating clinical trials
Five main benefits of automating clinical trials are:
- Faster clinical trials from start-up to completion.
- Save time, resources, and costs.
- Better quality data means better quality medicines.
- Results can be compiled and analysed faster.
- Better productivity throughout the clinical trial lifecycle.
Areas helped by automated processes in clinical trials
This refers to data gathered during clinical trials by way of case report forms (CRFs) or electronic case report forms (eCRFs). The process of developing forms can be automated. Validation is built-in so that forms are completed correctly and to ensure they meet regulatory requirements.
Software that automates CRF design and eCRF design results in better data quality, a faster data collection process and saved costs during the lifetime of a clinical trial.
Clinical metadata management
Clinical metadata management refers to centralised systems that allow companies to store and manage their metadata assets, such as forms, datasets and edit checks. They have governance built-in and standardised metadata can be reused across many studies.
The main benefits are reuse, regulatory compliance, increased data quality and process efficiency.
Dataset conversion processes
During various phases of a clinical trial, data must be submitted and resubmitted in the correct CDISC format to the FDA many times for review. Converting clinical trial data can be time-consuming and expensive.
By automating the dataset conversion process, there’s no need for complex programming. It’s much easier to meet regulatory requirements and it takes a lot less time to get clinical products to the market.
Why automation in clinical trials is essential
The costs and complexities of running clinical trials have never been greater. Without automation, getting high-quality clinical products to the market today would be almost impossible.
Fortunately, there are various technological solutions that automate processes for faster, more effective and more efficient clinical trials.
The Formedix clinical metadata repository and clinical automation platform is one such system that incorporates automation into various areas of the end-to-end clinical trial process.
You can import, store, manage and update your standardised metadata content in the Formedix clinical metadata repository.
It’s quick and easy to do your eCRF designs. You can create different metadata formats. You can see how your CRFs will look and how they’ll work in your electronic data capture (EDC) system before you build it. And you can preview your metadata in different formats.
Design your studies in a choice of seven EDCs. You can see what your forms look like and how they’ll work in your chosen EDC as you design them. Then, it’s one click to build your EDC database.
Quickly and easily add annotations to your CRFs. Once your CRFs are standardized, you can reuse your annotations. When your CRF design is complete, it’s 1 click to generate your submission ready annotated CRFs.
Generate study data tabulation model (STDM) datasets from source data in your EDC system. Simply define your mappings between source data to SDTM, then once you start collecting data, you can generate your SDTM datasets.
Generate SDTM define.xml in one click after you’ve built your study and defined your datasets. And one click to generate your ADaM define.xml. You can also generate define.xml from legacy datasets and SAS XPT files.
Formedix supports all versions of CDISC standards. You can be safe in the knowledge that your study designs and datasets are regulation-compliant.
When it comes to clinical trial submission, one of the most significant standards is the...
Most individuals’ first introduction to CDISC is typically through the use of Study Data Tabulation...
Metadata comes from multiple sources and can be stored in different places, systems and networks....