Dedham, MA — [ December 15, 2025 ] — Synterex, a WBENC- and DOBE-certified consulting firm specializing in AI-enabled regulatory and clinical writing, announced that AgileWriter.ai®, the flagship module of the company’s AgileSuite™ digital regulatory ecosystem, has joined the Veeva AI Partner Program.  The collaboration will integrate AgileWriter with Veeva RIM, part of the Veeva Development Cloud—the technology foundation that streamlines data and processes across clinical,

The biotech industry is buzzing with excitement following the FDA’s announcement of its Commissioner's National Priority Voucher (CNPV)...

Cancer unfolds when mitosis, or the process of cell reproduction, decides to break all the rules and go rogue. Despite significant strides in scientific understanding and cancer treatment, including use of artificial intelligence (AI) to accelerate cancer immunotherapy research, recent updates from the American Cancer Society cast a shadow on our optimistic journey.

AgileWriter™ is an AI tool designed specifically for medical writing, developed by experts in the field to meet the precise needs of clinical documentation. Importance of Subject Matter Experts: Involving subject matter experts (SMEs) in the creation of AI tools for medical writing ensures the tool is practical and meets user needs, avoiding misalignment and inefficiencies.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a third revision of its E6 Guideline, also known as ICH E6 (R3). This revision introduces new concepts and updates in the realm of clinical trial methodologies, with an emphasis on quality, flexibility, and modernization.