The Pinnacle 21 Clinical Metadata Repository (CMDR) empowers organizations to standardize, reuse, and govern clinical trial metadata with precision. By centralizing metadata management, the CMDR reduces study setup time, enhances data quality, and ensures compliance with CDISC standards.
With Pinnacle 21, study builds are completed in days rather than weeks, enabling faster patient enrolment and earlier trial initiation.
The Pinnacle 21 Clinical Metadata Repository provides a centralized platform for managing clinical trial metadata, ensuring consistency, compliance, and efficiency. By leveraging reusable, validated standards, organizations can streamline study builds and improve governance.
CMDRに再利用可能なバリデーション済みの標準を導入することで、スタディのセットアップにかかる時間を短縮できます。Now it’s possible to have study build completed in under 6 weeks!
CMDRでガバナンスワークフローを定義することで、学習コンテンツ開発の可視性と管理性を向上させます。
Having a library of approved, validated standards ensures quality and consistency when you’re using content across future studies and standards.
A CMDR provides the assurance of CDISC standards compliance, with built-in compliant templates for designing new content, and error prompts along the way.
Having impact visibility means you can now understand how potential changes will affect related standards and studies in your CMDR, enabling better informed decisions.
Gain visibility of access and updates to standards and studies across a trial’s lifecycle – with a full audit trail for complete transparency.
With faster study setup and EDC automation triggered from the clinical MDR, patient enrollment can start far earlier. Some pharmaceutical organizations have reduced study build from 15 days to just 2! And we’ve seen review cycles cut by half, from 8 days to 4. As a result, trials can start sooner, and lifesaving drugs can be brought to market far sooner.
Since you’re largely reusing validated standards to build studies, less manual work and fewer resources are now required. Skilled resources can be deployed elsewhere, meaning more cost-effective study setup.
With high quality, CDISC compliant standards in your clinical metadata repository, you’re in the best possible position for complying with the regulatory requirements required for submission.
With a foundation built on years of expertise in clinical data compliance, you’ll not only benefit from our innovative technology, but our also industry-leading technical services and support.
Our team’s deep-rooted knowledge of clinical data standards, such as CDISC, positions Certara as your trusted partner for expedited submissions, streamlined processes, and regulatory compliance.
Your data is safe with Pinnacle 21 Clinical Metadata Repository. Certara is ISO-certified, ensuring the highest level of data security and compliance for your clinical study submissions.
See how much better off you could be with the Pinnacle 21 Clinical Metadata Repository.
Transform your clinical trial workflows:
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. 臨床メタデータリポジトリの詳細についてはこちら>>
臨床メタデータリポジトリは、利害関係者が臨床研究に関連する文書やデータを見つけられるよう、一元的な場所を提供することを目的として設計されています。臨床メタデータリポジトリ（臨床MDRとも呼ばれる）は、臨床メタデータの管理を改善することを目的としています。期待される成果には、データの品質向上、一貫性の強化、データ分析の迅速化、新薬の市場投入の早期化などを含みます。
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