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Clinical trial disclosure is a key activity that shapes the public’s view of your company’s clinical practices. Our focused knowledge and rigorous techniques will maximize the impact that your disclosure work has on your company’s profile.

Our highly-trained and experienced team ensures accurate disclosure of your trial protocol and results in the global transparency forum. We are expert writers who understand the science, the systems, and the laws behind clinical trial disclosure. We specialize in extracting key information from your source documents then drafting clear and concise information to meet local registry requirements. We strive for excellence in both quality and timeliness.

Whether your organization is planning a Policy 0070 submission to the EMA, responding to an external request for clinical information, or preparing documents for upload to a registry, Xogene provides anonymization and redaction support for the full scope of clinical documents.

As a technology-oriented company with expertise in artificial intelligence, we leverage machine learning and pattern recognition to deliver high quality and cost-effective work. Services range from the full suite of support for Policy 0070 to a la carte redaction of specific documents.

Global Transparency Regulations in the European Union will soon require summarized trial results in a plain language format that is easy to read and accessible to a wide audience.

This requirement connects transparency initiatives with the people who benefit from them the most: patients, caregivers, friends, and family. Essentially, all of us.

For companies taking the important steps toward implementation of the lay summary initiatives, Xogene provides the critical skills to bridge the gap between clinical trial information and the patients who participate in them. Our transparency specialists extract key scientific data, translate medical texts into plain language, and package the summary in a visually appealing format. Our specialists and lay writers ensure that the trial information is summarized simply, fluidly and accurately without being promotional.