Specialist Fields

TEL 03-3355-1168


DocumentCRO® supports the globalization and acceleration of drug development

A reliable partner to many pharmaceutical companies, SunFlare supports the preparation of a range of documents in all phases of pharmaceuticals R&D, regulatory affairs, and post-marketing. To streamline the work associated with the various documents generated by our customers, we offer solutions that take full advantage of our proven expertise and experience. Have you ever experienced difficulties in preparing pharmaceutical documents? If so, why not contact us to find out how we can help?

Services We Offer

■ Medical Writing

  • Preparation of drafts for various types of documents (Japanese and English)
  • Translation of documents into English and editing by native English speaking professionals
  • Document revision, translation verification, and cross-checking of existing documents
  • DTP/template creation

■ QC Check

  • Checking of submission documents against source documents to ensure consistency (Japanese and English)
  • Peer review

■ Project Support

  • Support for high-volume/long-term projects
    Example: Preparation and translation of high-volume documents, such as CSRs and CTDs
  • Support for accelerated product launch
    Example: Speedy translation of documents to be sent to the relevant authorities (such as inquiry documents) and safety information
  • IT support
    Example: PDF conversion and processing, XML authoring and processing, OCR processing and scanning, database creation, XML authoring of clinical trial notifications, and translation updating using a text comparison tool
  • Support for the preparation of paper abstracts
    Example: Paper search, preparation of abstracts, and creation of abstracts databases
  • Academic conference support
    Example: Editing of conference materials by native English speaking professionals, creation and printing of posters for academic conferences, and audio transcription
  • Staffing services and educational support
    Example: Dispatching of human resources (translators, interpreters, etc.) and planning and implementation of educational training (English proficiency development, etc.)

■ China Market Entry

  • Prior patent research
  • China pharmaceutical consulting
  • Legal and standards research
  • Clinical trial support in China
  • CFDA regulatory affairs representative service
  • Preparation of regulatory dossiers
  • Introduction to Chinese business partners

We support our customers' smooth and speedy entry into the Chinese market by taking advantage of our unique contact network.

Documents We Handle

  • CMC documents
  • Study plans, study reports, SOPs, manufacturing records, design specifications, functional specifications, DMFs, etc.
  • Nonclinical documents
  • Study plans, study reports, SOPs, papers and literature, etc.
  • Clinical development documents
  • Investigator’s brochures, study protocols, informed consent forms, SOPs and manuals related to clinical trials, monitoring reports, case report forms, SAE reports, clinical study reports and appendix tables, SAE lists, concomitant medication lists, contribution papers, documents on work related to control drug negotiations, statistical analysis plans, etc.
  • Regulatory dossiers
  • CTD M1-M5, case narratives, abstracts, clinical trial notifications, face-to-face advice materials (clinical trial consultations, minutes, etc.), inquiries/responses, GCP compliance checklists, GCP inspection reports, review reports, etc.
  • Safety information documents
  • CIOMS, literature and academic conference reports, PSURs, post-marketing surveillance-related materials, post-marketing clinical trial-related materials, materials for reexamination requests, materials for reevaluation requests, SOPs, etc.
  • Academic documents
  • Contribution papers, abstracts, presentation materials, drug information, package inserts, Kusuri No Shiori (Drug Information Sheets), interview forms, etc.
  • Others
  • Patent and intellectual property-related documents (patent specifications, handling of office actions, etc.), legal documents (contracts), education-related documents (training textbooks), public relations-related documents (IR, websites, news releases, etc.)