
Medical Writing for Global Regulatory Submissions
Red Thread Consulting provides expert clinical document development services, process consulting and project governance.

Red Thread Consulting provides expert clinical document development services, process consulting and project governance.

Our mission is to deliver expert guidance and support in the development of regulatory documents, including clinical study reports, ensuring clear and effective communication of the messages for your drug product during dossier creation and throughout the product lifecycle, particularly in the context of clinical trials and medical writing, as well as protocol writing.

Our experienced team can provide a range of services, including medical writing, protocol writing, consulting, and governance and oversight for clinical trials. We can take responsibility for a clinical study report from the start or oversee its journey until completion. Our aim is to get it right the first time and in the shortest possible time, thereby reducing the number of inquiries you receive from agencies during the drug development process.

Red Thread Consulting adopts a collaborative consulting approach to support clinical trials and drug development initiatives. We engage closely with our clients to understand their requirements for medical writing and protocol writing, crafting solutions that address their distinct challenges. Our methodology is characterized by transparency, a focus on results, and a commitment to facilitating business success.
Our expertise in regulatory submissions and agency responses spans the globe, including the regions indicated on the map, and encompasses successful submissions of clinical study reports to the World Health Organization (WHO) as well as our contributions to clinical trials and drug development through precise medical writing and protocol writing.
Katharine and her team provide exceptional support in regulatory and medical writing throughout the clinical trial documentation development processes. From protocol writing to drafting clinical study reports and detailed correspondence with regulatory authorities, Katharine consistently delivers high-quality work under tight timelines. She leads cross-functional teams with agility and efficiency, making her an invaluable asset in the drug development landscape. I highly recommend Katharine and Red Thread Consulting’s services to any organization in need of top-tier regulatory and medical writing support.
Having worked in regulatory for over 25 years, including leadership roles in industry and consulting environments, I truly value and appreciate the experience, expertise, and absolute dedication that Katharine and her team provide. Katharine has supported various aspects of drug development, including NDAs/BLAs/MAAs (with responses to questions), CTA/INDs, scientific advice, orphan applications, and other briefing books. Her contributions to clinical study reports and protocol writing are invaluable, and she always brings insights into executional strategy. Katharine is consistently professional, always on-time, and adheres to agreed budgets. I have learned a lot about clinical trials through our collaboration! I am certainly looking forward to the next decade of working together.
I have collaborated with Katharine multiple times over the years on various medical writing projects, including clinical study reports and submissions to clinicaltrials.gov. She has a deep understanding of the complexities involved in our oncology trials and works seamlessly with our team to deliver exceptional reports. Katharine is always available to meet with our team, providing thoughtful input on each project, and her work is consistently completed on time and within budget. I highly recommend Katharine and Red Thread Consulting for any medical writing needs related to drug development and protocol writing.
