Informed Consent Form of an IND Submission with AgileWriter™

A small biotech needed an informed consent form (ICF) for an IND submission, with limited lead time following agency feedback. The challenge was compounded by a lack of prior materials and an untested template.

Synterex’s Solution:
AgileWriter™ was pretrained using draft sources and updated incrementally as new protocol information became available. The model’s output was so robust it was also leveraged to produce a pregnant partner ICF for the same study.

Clinical Study Report and Narratives Initial Draft in Record Time with AgileWriter™

A medium-sized biotech faced a tight deadline: a comprehensive Clinical Study Report (CSR) shell and first draft were needed in just two weeks, compared to the industry norm of six or more. The project was further complicated by complex oncology study design and data in less-than-ideal formats.

Synterex’s Solution:
Leveraging AgileWriter™, Synterex trained an AI model in real time, mapping planned content to a CSR template and SDTM datasets. As new information arrived, the model was incrementally refined, with a medical writer overseeing the process to ensure quality and compliance.

(White Paper) This One’s for the Children: Progress in Pediatric Drug Development in the United States

Prior to the FD&C Act, pharmaceutical companies were not required to provide proof of drug safety or a disclosure of all active ingredients. Since then, all new drugs undergo an intensive review process by the Food and Drug Administration (FDA), and ever-evolving guidance and regulations ensure that both new drugs and those with updated characteristics, such as dosing, delivery, and expanded indications, are safe and effective for the intended populations. A gap remains, however, for drug investigations including and targeted for children of varying ages.

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(White Paper) The Road to Representation in Clinical Research

Innovative development of human drugs, biologics, and medical devices (medical products) and their quick advancement through the United States Food and Drug Administration (FDA) approval pipeline is necessary to improve the lives of patients. It is also imperative for sponsors to consider diversity when enrolling study participants throughout the clinical development pipeline to adequately represent the population of patients who have a disease or condition.

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