Synchrogenix

Certara’s Synchrogenix launches AI transparency solution

Monday, March 28, 2016

Certara, a global biosimulation technology-enabled drug development company, has announced that its regulatory and medical consultancy, Synchrogenix, has introduced an artificial intelligence- (AI-) enabled solution to meet the data transparency requirements of the clinical and drug development market. Those detailed requirements were published by the EMA on March 2 as Policy 70.

[Read More]

Determining the best way to redact sensitive material prior to disclosure

Friday, May 15, 2015

Transparency and disclosure of clinical trial information has been growing in importance. Providing previously confidential clinical study results for public consumption is a key step toward increasing trust between the public and the industry and encouraging information sharing that could lead to new products or therapeutic approaches.

[Read More]

Synchrogenix partners with CISCRP on transparency, developing lay language trial summaries for participants

Monday, May 4, 2015

Synchrogenix, a unit of Certara, has partnered with the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) in an effort to expand lay language summaries for patients who participate in clinical trials. The two will provide more plain language accounts of a clinical trial’s design, objective and findings, also meeting sponsors’ clinical data transparency requirements.

[Read More]

Certara’s Synchrogenix acquires ClinGenuity

Wednesday, January 7, 2015

Synchrogenix, the regulatory and medical consultancy of Certara, a Princeton, N.J.-based global biosimulation technology-enabled drug development and drug safety consulting company, has acquired ClinGenuity, a Cincinnati-based artificial intelligence-assisted medical writing service. Their combined team now will include more than 200 regulatory and medical writers with experience in document development for the FDAEMA and other global regulatory organizations.

[Read More]