Technology that powers operational efficiencies

According to analysis by the Tufts Center for the Study of Drug Development, the average cost to develop and gain marketing approval for a new drug is $2.55 billion. A quarter of this cost is in content creation and meeting regulatory requirements.

Certara has developed leading technologies that save time and resources during the regulatory preparation and submission process, so you can get your therapeutics and medical devices to market faster.

As key opinion leaders, our regulatory technology specialists speak regularly at major industry events, including transparency and disclosure conferences, DIA meetings, PHUSE, and RAPS Regulatory Convergence.

Maximize your Data Fitness Score with Pinnacle 21

Pinnacle 21 offers a broad suite of solutions for your data needs: speccing, mapping, cleaning, checking, comparing, transforming, converting.

Validation: Analyze your data quality, see issues that affect FDA/PMDA review, and get insights into fixes with our leading engine.

Issue management: Delegate, fix, or explain issues across decentralized teams and sites.

Define.xml: Create 100% compliant Define.xml files with our intuitive, automated designer.

Reviewer’s guide:  Advocate for your data and share their full context in our xDRG creator.

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Maximize your Data Fitness Score with Pinnacle 21
GlobalSubmit eCTD Submissions Management Software

GlobalSubmit eCTD Submissions Management Software

Efficiently publish, validate and review electronic submissions.

  • GlobalSubmit PUBLISH for more efficient document and submission level publishing and QC
  • GlobalSubmit VALIDATE helps to ensure the technical validity of your submissions for the region to which you are submitting
  • GlobalSubmit WebReview for streamlined submission review, anytime and anywhere

GlobalSubmit CROSSCHECK to efficiently QC your bookmarks and hyperlinks to not only make sure they are technically sound, but also directing reviewers to the correct locations in your submissions

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Synchrogenix eCTD Authoring Template Suite

We’ve paired our technical experts with our team of leading regulatory professionals to create a comprehensive eCTD authoring template suite.  Based on our thirty plus years of planning, writing and publishing hundreds of global submissions, our template suite simplifies document creation and review and establishes a standardized approach to document development across different disciplines to ensure efficiencies.

  • Instructional text with current agency guidance maintained by regulatory experts
  • Specialized toolbar containing standardized shortcuts and symbols
  • Access to expert advice and technical support at all steps along the way

With toolbar features such as automatic formatting and easy table creation/conversion, our users spend approximately 50% less time on document formatting.

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Synchrogenix eCTD Authoring Template Suite
Synchrogenix Writer

Synchrogenix Writer

Power your safety reporting by applying our experts and technology-enabled service delivery.

Reduce time to completion of large narrative projects while providing consistency.

  • Use Synchrogenix Writer’s narrative builder features to efficiently manage thousands of narratives to full completion, including review, in a fraction of the time
  • Templates can be developed/tested with pre-Database Lock data with no additional work required using post-Database Lock data
  • Gain speed, quality, and consistency across your narrative set
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Engage with Patients via PODIUM

As a complement to our commitment to enhance engagement of patients, caregivers, clinicians, and patient advocates in drug development, we’ve created PODIUM. Using our secure PODIUM platform, sponsors can receive valuable responses throughout the clinical trial process from patient groups within specified therapeutic areas.

  • Inform protocol feasibility by engaging with patients in the study planning/development stage
  • Provide feedback on documents intended for patient use, including informed consent forms and patient summaries of EU Risk Management Plan

Allow patient groups an opportunity to provide comments and assess readability of the plain language summary

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Engage with Patients via PODIUM
Optimize your Medical Communications with BaseCase

Optimize your Medical Communications with BaseCase

Visualize your complex data, optimize medical communications, and create intuitive interactive apps – all without programming. Using Certara’s BaseCase platform, you can develop a range of content that presents key messages and outcomes in a clear and easy-to-understand way.

  • Engage your audience at congress’ & symposiums with dynamic and interactive versions of presentations and publications to maintain audience attention.
  • Educate your customers with relevant and tailored product information such as, clinical trial & plain language summaries, treatment pathways, and epidemiological research.
  • Communicate product value to key opinion leaders and stakeholders to ensure your product gets the right exposure, and to facilitate clear value-based discussions during meetings.
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Justin Savesky
Justin Savesky Sr. Director, Regulatory Science Technology

Justin has been immersed in the technology field for regulatory science for over eight years.  He leads Synchrogenix technology commercialization efforts, including product strategy and management.

Gabriella Mangino
Gabriella Mangino Product Manager, Synchrogenix

Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.

Nirpal Virdee
Nirpal Singh Virdee Global Head of Transparency & Disclosure

Nirpal comes with over 18 years of Life Sciences experience. He is a subject matter expert in the Clinical Development, Regulatory Landscape, Transparency and Disclosure space. He is considered an industry thought leader, having globally presented at conferences. He has sat on industry advisory panels. At Synchrogenix , Nirpal is accountable for business development, client management and consulting for technology enabled services.

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