Medical Writing

Concise. Professional.

Clear, concise, and professional presentation of study findings is an important factor in any development program. With a full complement of medical writing services, PharmaNet/i3 Strategic Resourcing professionals can provide all your documentation and writing needs. Comprised of scientists, many with advanced degrees, PharmaNet/i3’s medical writing team has significant expertise in key therapeutic areas of pharmaceutical and biotechnology clinical development. They work directly with you to ensure consistency with your format and style while maintaining full compliance with regulatory requirements and International Conference on Harmonisation (ICH) guidelines. PharmaNet/i3 Strategic Resourcing has a proven track record of timely delivery of quality medical writing deliverables coupled with outstanding customer service.

PharmaNet/i3 Strategic Resourcing FSP medical writing services are organized to provide medical writing services on a project-by-project or functional outsourcing basis. The functional service provider (FSP) model is characterized by dedicated resources -- aligned by function, therapeutic area, or project phase -- who work exclusively with a single customer. This model allows the dedication of a core team of writers with leadership focused on identifying and implementing process efficiencies. PharmaNet/i3 Strategic Resourcing maintains responsibility for overseeing and managing staff, but provides resources and leadership to move large portfolios of documents through the drug development pipeline.

PharmaNet/i3 Strategic Resourcing employs 160 writers, editors, and writing management staff. Most of the writers (75%) are regulatory focused by training and prepare documents related to clinical trial conduct, reporting, and regulatory submissions. Fifteen percent prepare commercialization documents including abstracts, posters, manuscripts and medical information letters. The remaining ten percent focus on discovery, preclinical, technical or safety-related documents. They write hundreds of major documents every year, including protocols, clinical study reports, annual reports, investigator brochures, manuscripts, and posters. In addition, to 160 FTEs listed in the table below, PharmaNet/i3 Strategic Resourcing maintains contractual relationships with approximately 60 additional writers who perform writing services for us as needed.

Most of our medical writing staff is located in North America and we also have resources in India. Therapeutic experience includes neuroscience, oncology, cardiovascular, critical care, autoimmune, diabetes/endocrine, infectious disease, men's health, women's health, and osteoporosis/bone metabolism.

Let PharmaNet/i3 Strategic Resourcing professional writers help you with:

Regulatory Writing

  • Protocols and protocol amendments
  • Informed Consent Forms/Patient Information Leaflets
  • Clinical study reports
  • Subject narratives
  • Investigator Brochures
  • Integrated summaries of safety/efficacy
  • Literature summaries
  • Clinical expert reports
  • INDs, NDAs, BLAs, CTAs (Module 2) summary documents
  • IND and NDA Annual reports
  • Safety Aggregate Reports (PSURs, PADERS, Line Listings, DSURs)
  • Clinical trial registry synopses

Scientific Manuscripts

  • Manuscripts
  • Abstracts
  • Posters
  • Symposia publications
  • Slide presentations
  • Publication plans

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how we can help you