The Certara Blog

Author: Kim Green

Ms. Green, who joined Synchrogenix in 2003, is the Director of Team Leads and a senior regulatory writer with a background in preclinical, clinical, and drug safety documents. Among her work, Ms. Green has produced and led other writers in producing a variety of regulatory documents, including clinical study reports (CSRs), periodic safety update reports (PSURs), investigator’s brochures (IBs), integrated summary documents for submission, as well as research methods, reports, and training documents. Ms. Green has also registered clinical trials protocols and posted results to the Protocol Registration System (PRS) and EudraCT, performed quality review for safety reports in multiple therapeutic areas, and has developed internal reports for new pharmaceutical product submission, including formatting to comply with client style guides and evaluating lab data.

Recent Posts

Improve Your Approach to Sharing Clinical Trial Data

Transparency and disclosure of clinical trial data has been a hot topic, growing in prominence and strategic discussions over the past few years. Disclosing clinical trial information and creating transparency around clinical trial results are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur […]

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