Pinnacle 21 – Clinical Metadata Repository
Leverage our Clinical Metadata Repository to build studies with greater speed & quality
Define, reuse & govern standards in our Clinical MDR
It all starts with standardization. Get your standards in place, and you’ve paved the way for getting higher quality clinical trial data, faster. Study builds and review cycles take days, not weeks. As a result, patient enrolment can start far earlier.
The Pinnacle 21 (P21) clinical metadata repository (CMDR) provides a central cloud platform to author, share, reuse and govern standards. And with our clinical MDR as your foundation, you can drive EDC and SDTM automation downstream, to optimize trials even further.
We’ve seen organizations reduce study setup from 15 days to just 2!
Why implement a Clinical MDR?
Faster study build
Having re-useable, validated standards in a CMDR saves time on study setup. Now it’s possible to have study build wrapped up in under 6 weeks!
Improved governance
Gain visibility and control over study content development by defining a governance workflow in your CMDR.
Greater quality
Having a library of approved, validated standards ensures quality and consistency when you’re using content across future studies and standards.
Effortless CDISC
向上
A CMDR provides the assurance of CDISC compliance, with built-in compliant templates for designing new content, and error prompts along the way.
Make informed decisions with impact visibility
Understand how potential changes will affect related standards and studies in your MDR, so you can make more informed decisions.
Ensure data integrity with full traceability
Gain complete visibility of access and updates to standards and studies across a trial’s lifecycle – with a full audit trail for full transparency.
Build studies up to 85% faster with Pinnacle 21’s Clinical MDR
How you’re better off with P21’s Clinical Metadata Repository
Start trials earlier & speed drugs to market
With faster study setup and EDC automation triggered from the clinical MDR, patient enrollment can start far earlier. Some organizations have reduced study build from 15 days to just 2! And we’ve seen review cycles cut in half, from 8 days to 4. So trials get underway quicker, and lifesaving drugs can be brought to market far sooner.
Cut costs & increase productivity
Since you’re largely reusing validated standards to build studies, less manual work and fewer resources are required. Skilled resources can be deployed elsewhere, meaning more cost-effective study setup.
薬事申請書類の却下リスク低下
With validated, high quality standards in your clinical metadata repository, you know that the content you’ll reuse already complies with CDISC and other regulatory regulations. So that’s your road to submission approval sorted!
Clinical study build made easy
With the clinical MDR underpinning our platform, you can automatically build your EDC from standards in Pinnacle 21.
1.
Develop and gain approval for organizational standards in the CMDR with predefined or customized workflows.
2.
Select relevant content from standards in your clinical metadata repository to build a study (e.g. forms, datasets, mappings).
3.
Add any required visit schedules, custom edit checks, custom mappings etc. Visualize studies for your EDC in the clinical MDR.
4.
Validate your study against internal and regulatory standards to ensure compliance.
5.
Build your study for your chosen EDC from the Pinnacle 21 platform. Generate submission deliverables and required datasets.
お客様の声
What are the benefits of standardization, and is it worth it?
Watch this webinar to learn the efficiencies gained by implementing standards, and the before/after results you could achieve.
Pinnacle 21 とFormedixが提携しました！
サターラの統合プラットフォームは、主要な関係者間のコラボレーションとデータフローを改善し、デザインから申請まで、より迅速で質の高い臨床試験を可能にします。
Formedix製品ryzeの詳細はこちら > formedix.com
P21 Enterpriseの詳細はこちら > pinnacle21.com
コンテンツ
Clinical Metadata Repository FAQs
Clinical metadata refers to the metadata used in clinical trials. Study data is the raw patient data collected during a trial. Metadata describes or provides information about the study data. It gives context to the data and provides a deeper understanding of the data. For example, dataset metadata provides context about the properties of a dataset, such as dataset name, label, and class. Variable metadata provides information about variable properties, such as format, type and controlled terminology.
Metadata is information that describes or explains the data collected during a clinical study. Metadata is often referred to as ‘data about data’. Clinical metadata management refers to the process of collecting, seeing, updating, cleaning, and managing clinical trial metadata.
A clinical metadata repository (also known as a clinical MDR) is a cloud based software tool to help data management professionals locate documents and data related to a clinical study. It’s a library for storing, sharing, managing and reusing standardized metadata assets, such as forms, datasets, terminologies and mappings. A clinical metadata repository is often referred to as a ‘single source of truth’ since it provides a centralized location for all relevant clinical trial metadata.
A clinical metadata repository is designed to provide a central location for stakeholders to find documents and data related to clinical studies. A clinical metadata repository – also known as a clinical MDR – is intended to improve the management of clinical metadata. Expected outcomes include increased data quality, greater consistency, faster data analysis, and earlier launch of new medicines to market.
