Medical Affairs

Putting the complexities and technical nuances of a clinical trial into clear, concise and comprehensive language that satisfies regulatory bodies requires a special kind of talent, in addition to specialized expertise. Regulatory affairs and medical writing comprise an integral part of our clinical trial teams, translating the science into actionable words. 

Our services include:

  • Medical Writing
  • Regulatory Affairs
  • Technical Writing
  • Quality Assurance
From the Investigator’s Brochure (IB) and initial protocol development to the Clinical Study Report (CSR), Clinical Evaluation Report (CER) and New Drug Application (NDA), medical writing is needed throughout the clinical trial process. Using our collaborative, multidisciplinary approach, our specialists in Technical and Regulatory Writing work with regulatory affairs, data management and statistical groups to ensure nothing is missed or misconstrued. This collaboration transitions seamlessly after the trial to incorporate Product Labeling Rule (PLR) requirements in manufacturing and provide post-market reporting.

Our Expertise
Through our strategic partnership with Aerotek, we are able to tap into the largest network of clinical talent in the U.S. to meet specific needs. But our reach doesn’t end there, with global offerings that range from producing European Medical Association (EMA) regulatory filings to offshoring writing tasks, our expertise expands across countries and time zones. We meet the needs for each trial with the right expertise in:

  • Multiple Therapeutic Areas
  • Drug Development
  • Pharmacology
  • Drug Safety
  • Statistics 
  • Regulatory Guidelines

Consultative Approach
Communication is nowhere more crucial than in medical affairs. We provide a central point of contact who listens, incorporates and proactively addresses feedback from our customers. This feedback not only ensures needs are addressed, but also helps develop our people, contributing to our class-leading retention. By creating a deep understanding of the needs of each trial, we ensure consistent, knowledgeable communication with our customers and in our medical writing.