Enhancing Regulatory Submissions with Pinnacle 21 for Faster Results
Transforming Clinical Data Management with Pinnacle 21 Enterprise Plus
Certara, Inc. (Nasdaq: CERT), a leader in the field of biosimulation, has recently introduced a groundbreaking solution known as Pinnacle 21 Enterprise Plus. This innovative platform is designed to greatly enhance the process of preparing and managing necessary data specifications for clinical studies. With a strong emphasis on efficiency, Pinnacle 21 Enterprise Plus is set to revolutionize how clinical and statistical programmers approach dataset creation for regulatory submissions.
Streamlining Data Specification Management
For years, the industry has relied heavily on traditional methods such as spreadsheets for managing data specifications. Unfortunately, these practices are often fraught with challenges, including a high potential for errors, difficulties with version control, and limited collaboration capabilities. Certara's Pinnacle 21 Enterprise Plus directly resolves these issues by providing a unified workspace where teams can collaborate seamlessly, ensuring faster progress from raw data to ready-for-submission datasets.
Key Features of Pinnacle 21 Enterprise Plus
The newly launched Pinnacle 21 Enterprise Plus boasts an intuitive no-code interface aimed at significantly reducing the time needed for drafting mapping specifications. Internal assessments have shown that users can expect up to a 50% decrease in this task, leading to more efficient workflows and timely submissions.
Collaboration Made Easy
One of the standout features of Pinnacle 21 Enterprise Plus is its compatibility with both industry standards like CDISC as well as proprietary requirements tailored to specific organizations. This flexibility ensures that users can easily adapt the platform to meet varying regulatory guidelines, fulfilling both public and private sector demands.
Accelerating the Submission Process
In the context of biopharmaceutical development, time is often of the essence. Slow submission cycles can create significant delays that ultimately hinder patient access to new therapies. Pinnacle 21 Enterprise Plus aims to expedite this process by facilitating earlier and more efficient creation of SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) mapping specifications. By streamlining these essential tasks, companies can mitigate end-of-study delays and enhance their agile response to regulatory requirements.
Building Towards a Future-Proof Platform
William F Feehery, CEO of Certara, articulated the company’s commitment to advancing the field of data sciences through these innovative updates. “By expanding Pinnacle 21, we are investing in the future of data sciences,” he stated, highlighting the importance of these tools in accelerating the regulatory submission process for new treatments.
Endorsements from Global Leaders
Pinnacle 21 Enterprise Plus is already being utilized by over 130 organizations around the globe. Notably, it has gained the trust of leading biopharmaceutical firms and regulatory authorities, including the US FDA and Japan's PMDA. This widespread adoption solidifies Certara’s reputation as an industry pioneer in clinical data standardization and validation.
Certara’s Commitment to Innovation
In a statement reflecting on the evolution of the Pinnacle 21 product suite, Martin Snyder, President of Certara Data Sciences, emphasized the company's goal of creating a comprehensive platform. “We are building a future-proof platform that delivers end-to-end data standardization and validation,” he remarked. The continued enhancements demonstrate Certara's dedication to staying ahead of the curve in this dynamic field.
About Certara
Certara is dedicated to speeding up the development of new medicines through advanced biosimulation software and related services. With a diverse client base encompassing more than 2,400 biopharmaceutical companies, regulatory bodies, and academic institutions across 70 countries, Certara stands at the forefront of innovation in drug discovery and development processes. To learn more about how Pinnacle 21 Enterprise Plus and other solutions can advance your regulatory submissions, visit Certara’s official website.
Frequently Asked Questions
What is Pinnacle 21 Enterprise Plus?
Pinnacle 21 Enterprise Plus is a software solution designed to enhance the management of clinical data specifications, facilitating faster and more accurate regulatory submissions.
How does it improve data specification management?
The platform offers a collaborative workspace and a no-code interface that significantly reduces the time needed to draft mapping specifications, improving efficiency and accuracy.
What benefits does Pinnacle 21 provide?
It ensures compliance with industry standards, facilitates integrations with programming tools, and enables faster submission cycles for regulatory approval.
Who can use Pinnacle 21 Enterprise Plus?
This platform is tailored for clinical and statistical programmers, making it essential for teams involved in data validation and submission processes.
What makes Certara a leader in the industry?
Certara's commitment to innovation, combined with its vast global client base and trusted solutions, positions the company as a leader in clinical data management and biosimulation.
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