Document development services include:
By involving writers and publishers from early on in the drug development process, we enable a proactive approach to managing the red thread from investigational medicinal product dossiers (IMPD) through to the application for marketing authorisation (MA) and other product-related documents, including registries. We consult on the alignment of the dossier and summary of product characteristics (SmPC) with development safety update reports (DSURs), investigator brochures (IBs), periodic benefit-risk evaluation reports (PBRERs), and risk management plans (RMPs or REMs), ensuring that the red thread remains intact.
Red Thread can work with you to create document templates for submission-specific or reusable company-wide protocols and clinical study reports (CSRs). Our skilled writers can author documents ranging from single study components to more complex Module 2 clinical summaries and overviews. With the option of AI-augmentation, our authors leverage AI-assisted data extraction to accelerate first drafts while maintaining full scientific oversight. Automated cross-referencing between tables, figures, and narrative ensures data integrity before undergoing human QC review. AI enhances, but never replaces, expert judgment, allowing us to maintain the red thread throughout the authoring and review process.
Additionally, our authors collaborate closely with your publishing teams to deliver submission-ready documents that comply with regulatory requirements. We offer a quality control (QC) service tailored to your standard operating procedures (SOPs). Our dossier creation and submission service can be comprehensive or modular, and our consultants are available to guide and support you throughout the entire process.
Our experienced consultants can review your existing document and submission authoring processes. Redthread consultants provide guidance on the authoring of regulatory documents tailored to your company needs. Our consultants work with you to engineer changes through the writing of standard operating procedures (SOPs), working practices and instructions, in addition to the provision of in‑house training on new processes.
We also help pharmaceutical companies implement AI-augmented medical writing workflows, including tool selection, SOP development, writer training, validation protocols, and change management.
Redthread consultants can advise you on any, or all of the writing steps involved in dossier creation, conversion and lifecycle management. Our consultants consider regulatory requirements that are specific to your product, the target market, the submission type and the submission format.
Use our management support to provide ad hoc, part‑time or interim management of your projects, teams or outsourcing.
Red Thread is experienced at delivering high-budget, complex and milestone-driven medical writing projects via the governance and oversight of internal and outsourced teams, detailed budget tracking, risk management (including assessment and mitigation), process consultancy, and cross-functional interactions.
Red Thread recognise the importance of team contributions/interactions and the medical writer’s role in managing that relationship. Working collaboratively with functional/therapeutic experts, we ensure that key messages are consistent, supported and maintained across the entire product dossier and throughout its lifecycle.
We ensure that quality is achieved through the compliant use of standard operating procedures (including quality control), regulatory guidance and data privacy/protection.