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Certara Announces Strategic Initiatives to Bolster Clinical Trial Transparency and Disclosure Services

Certara strengthens transparency and disclosure leadership with launch of new Podium™ platform for patient engagement and appointment of industry veteran

PRINCETON, N.J.—十月 27, 2020. Certara, a global leader in biosimulation, today announced that its regulatory science division, Synchrogenix, continues to build on its clinical trial transparency and disclosure position by introducing a new technology platform for patient engagement and recruiting key talent.

“Global regulatory changes like EMA Policy 70 and Health Canada’s PRCI initiative have mandated the transparency and disclosure of clinical trial data,” said Justin Edge, president of Regulatory and Access at Certara. “We have been a leading provider of technology-enabled solutions to sponsors for more than six years with our ClinGenuity platform.  It is now time to further step up our investment in talent and technology to enable patient engagement.”

Certara recently launched its Podium™ platform, an online patient engagement portal that enables direct feedback from patients on clinical trials. It has partnered with patient panel companies to ensure that representative groups of patients suffering from specific conditions can provide comments and assess readability of plain-language summaries of clinical trial results for those same conditions.

Certara continues to deploy its ClinGenuity redaction technology alongside a global team of in-house statisticians and experts to help clients comply with the evolving regulatory requirements for quantitative risk and advanced anonymization of trial data.

Certara is also strengthening its transparency and disclosure team with its recent hire of Mari Welke as director of safety and innovation at Synchrogenix. Ms. Welke brings nearly 25 years of industry experience, from both sponsor and service-provider perspectives, spanning clinical development, medical writing, safety analysis, and clinical trial disclosure.

“At Certara, we are committed to putting patients first and believe that, through the application of innovative technology, we can further advance our patient mission,” said Welke. “By innovating regulatory technology solutions, we can engage with patients and save time and resources to accelerate the development and delivery of crucial medicines.”

To learn more, please visit https://www.certara.com/regulatory-science/transparency-disclosure/.

About Certara

Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.


Media Contact:

Elizabeth Tang, Ph.D. 212-715-1579
Finn Partners
elizabeth.tang@finnpartners.com

Media Contact:

Jieun W. Choe, Chief Strategy and Marketing Officer. jieun.choe@certara.com
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