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Medical Writing

 

 

CRITICAL COMMUNICATION IN MEDICAL WRITING

Effectively communicating the data package for investigational products and devices to regulatory authorities and investigators is a daunting task. Our medical writing services alleviate this challenge by offering proficiency and expertise at every stage of clinical development.

Crafting documents for regulatory submissions and investigators requires gathering information from various teams, ensuring appropriate detail for each audience and weaving disparate pieces into a cohesive narrative. This task is particularly crucial for complex treatment modalities and novel therapeutic targets, where clarity is paramount in regulatory submissions.

Our medical writing offers experience in diverse indications, treatment modalities, and document submissions. Leveraging a wealth of regulatory, clinical development, and quality and compliance knowledge, we ensure your documents are clear, concise, and compliant.

We offer a comprehensive suite of medical writing services tailored to your needs. Whether you require us to author all Module 2 summaries, protocols, and investigator brochures for your IND submission, or need support in specific areas, we provide flexible solutions.

Our consultants lead or support the authoring of various documents, including:

  • IND Module 2 summaries
  • Investigator brochures
  • Protocols
  • FDA meeting requests
  • Clinical study reports

With expertise spanning oncology, neurology, endocrinology, and diverse therapeutic approaches, they excel at distilling complex scientific information into digestible summaries.

By combining medical writing with regulatory operations services, we ensure your regulatory submissions effectively convey key messages and adhere to regulatory guidance. With Halloran, you can trust that your documents will streamline the regulatory process and support the success of your clinical development endeavors.

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Halloran has the team and the experience to help you in your lifecycle journey. Contact us today to learn more about how we can help you!