Clear, concise, and professional presentation of study findings is an important factor in any development program. With a full complement of medical writing services, Clintract professionals can provide all your documentation and writing needs. Comprised of scientists, many with advanced degrees, Clintract’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. Clintract has a proven track record of timely delivery of quality medical writing deliverables coupled with outstanding customer service.

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Clintract's 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. Clintract maintains responsibility for overseeing and managing staff, but provides resources and leadership to move large portfolios of documents through the drug development pipeline.

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Clintract maintains contractual relationships with writers who perform writing services for us as needed.  Therapeutic experience includes neuroscience, oncology, cardiovascular, critical care, autoimmune, diabetes/endocrine, infectious disease, men's health, women's health, and osteoporosis/bone metabolism.

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Let Clintract professional writers help you with:

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