지디에프아이 브레인셀연구소

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Medical Writing

국제법령과 글로벌 임상표준화를 충족하는 GDFI Braincell Laboratory

의학 전문가에 의한 MSL(Medical Science Liaison Services) 약물정보, 질병정보 및 임상시험 약물의 안전성•부작용(Adverse Effect and Safety of Study Drugs)을 검토하여 임상시험용 의약품의 정보를 제공하고 있습니다.

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Protocol 개발단계에서 RA부서와 긴밀한 협조를 통해 protocol, CRF 및 ICF 개발을 지원해 드리며 MFDS 및 ICH E3 CSR Template를 사용한 기술적 가치와 고품질의 CSR 결과물을 Medical Writer가 제공해 드립니다.

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연구개발에 의한 새로운 시험용 의약품 임상에 관한 약물조사 및 부작용 정보를 임상시험에 활용할 수 있도록 지원해 드립니다.

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7-1. Medical Writing

  • Preparation of Investigators Brochure
  • Review of protocol & Case Form Research
  • Review of Informed Consent Form
  • Medical Information, Scientific Information Survey Services
  • medical Science Liaison Services
  • Adverse Effect and Safety of study drugs
  • Ensure that the interfaces between Medical and other departments are managed optimally
  • Development of Clinical Study Report (CSR)
  • Publication Support
  • Preparation of Investigators Brochure
  • Review of protocol & Case Form Research
  • Review of Informed Consent Form
  • Medical Information, Scientific Information Survey Services
  • medical Science Liaison Services
  • Adverse Effect and Safety of study drugs
  • Ensure that the interfaces between Medical and other departments are managed optimally
  • Development of Clinical Study Report (CSR)
  • Publication Support
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