Medical Affairs and Writing Services

Our Medical Affairs and Writing professionals specialize in providing scientific expertise to the medical community. We provide contract services and support our clients in three distinct areas: Medical Affairs, Medical Information / Pharmacovigilance, and Medical Services.

Medical Affairs

The medical affairs function at pharmaceutical companies is accelerating beyond its traditional support role into a matrix of major responsibilities bridging research and development and marketing function efforts. Providing physicians, key opinion leaders, regulatory agencies, advocacy groups, and professional organizations with medical and scientific information and education, the medical affairs function enhances sales and marketing efforts and complements the work of Research and Development to maximize a product's total value through continued clinical studies, outcomes research, and disease management programs.

To fulfill the requirements of its growing strategic role, the Medical Affairs function needs to continuously re-invent itself by optimizing its overall capabilities, including:

  • Medical Research (medical directors, medical operations, outsourcing and contract administration)
  • Health Economies / Outcomes
  • Data Management and Biostatistics
  • Medical Information (medical information and call centers)
  • Scientific / Medical Liaisons (medical liaisons, medical training, medical relations)
  • Medical Communications (medical writing and medical communications)
  • Medical Education

Medical Information / Pharmacovigilance

ICG's team of trained healthcare professionals is adept at handling medical inquiries, including reporting of adverse events, product related medical inquires, and product complaints.

Our Medical Information Services (MIS) team works with our clients to create standard responses and frequently asked questions (FAQ) documents based upon internal and client standard operating procedures (SOPs) and processes. As appropriate, our MIS professionals will also fulfill literature requests. Medical Information specialists can create and update standard responses and SOPs as well as identify new topics and develop customized responses.

Specific to our Pharmacovigilance services, we also provide a broad range of adverse event and product complaint support from MedWatch form completion to activities such as narratives, summary reports, physician follow-up, patient contacts, and preparation of annual adverse event reports. All adverse events and product complaints, regardless of serious or non-serious classification, are submitted to clients in a timely manner. Expedited reports are submitted within one business day.

ICG maintains a comprehensive, detailed database and incorporates all call details into this database, seamlessly operating as the company's Medical Affairs Department.

Medical Services

ICG also provides its clients with project support including medical writing, medical meeting support and field training services. Medical writing may include abstract, poster, and SOP development. Medical meeting support encompasses utilizing one or more of ICG's healthcare professionals on a per diem basis supporting activities such as MIS support at a scientific booth during a medical conference.

Medical Writing

ICG provides medical writing services that cover scientific, nonclinical, and clinical (phase 1-4) research activities. ICG’s medical writing team is highly skilled with scientific and/or medical backgrounds and experience in industry within multiple therapeutic areas.

Regulatory Writing

  • NDAs/CTDs
  • Briefing books
  • Advisory committee presentations
  • Annual reports
  • INDs
  • Package inserts

Clinical Writing

  • IBs
  • Protocols
  • CSRs
  • Patient narratives

Scientific Writing

  • Abstracts
  • Posters
  • Manuscripts
  • Conference presentations
  • Advisory board presentations
  • Literature-based research
  • White papers
  • Competitive intelligence reports
  • Patent applications
  • Grants
  • Blogs
  • Press releases

 

For more information on ICG’s Medical Affairs and Writing services, please Contact Us.