Certara - Pinnacle 21

AKT Health Analytics has partnered with Certara. We are the sole promoters and distributors of Certara's products in India, Bangladesh, Nepal and Sri lanka. We already serve over 100 Pharma companies and CROs with regards to Certaras products.

About Certara

Certara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.

About Pinnacle 21
Pinnacle 21 is a global leader in software for preparing clinical trial data for regulatory submission. Our platform validates data quality and compliance with CDISC standards, enabling a clean data pipeline from worldwide sponsors to health authorities, including the FDA, PMDA and NMPA. Streamlined approvals bring life-saving medicines to patients faster.

Datasets against  rejection criteria to fix issues in advance, mitigate risk, and accelerate the review process.

• Use the dashboard and scoring algorithm to monitor progress toward submission readiness. 
• Track changes between validation runs with clear before and after views. 
• Dig deeper into your data composition with our pre-built reports to surface patterns and inconsistencies.

Pinnacle 21 Enterprise validates data quality and compliance with Clinical Data Interchange Standards Consortium (CDISC) standards, enabling a clean data pipeline from worldwide sponsors to health authorities.  Pinnacle 21 Enterprise customers include 22 of the top 25 biopharmaceutical companies by R&D spend, as well as the US FDA and Japan’s Pharmaceutical and Medical Devices Agency.

Pinnacle 21 Enterprise 5.1.0 includes new and advanced capabilities, such as:

• Support for recently released Define-XML 2.1 standard
• New analytics module for portfolio-wide summary statistics and insights, highlighting performance by asset or therapeutic area and identifying frequent unresolved validation issues
• Automation and intuitive capabilities with auto set-up of latest dictionaries, alignment of upload sources over time, simplified roles and assignments, and bulk-actions for user management and company-specific settings.

About AKT Health Analytics

AKT Health is a Healthcare & Life Science Strategy Consulting firm. AKT Health partners with life science companies and health systems to develop a market-leading strategy for long-term top performance, engagement, growth, and sustainability.

Our consultants evaluate data, apply analytical models, study systems, and dissect workflows to unlock opportunities to improve performance through technology enablement and engagement planning. We collaborate with healthcare providers to implement improved processes and create efficiencies that can withstand changes within the industry.

For more information, write to us at info@akthealth.com or call +91 7997776410