NexusCRO provides a range of integrated services that cover the planning, management, execution and analysis of Phase I – IV trials.

NexusCRO's fastest-growing therapeutic area and testament to our success in conducting oncology clinical trials.

NexusCRO's experience in cardiovascular trials is supported by a global team of cardiovascular experts.

NexusCRO will be able to advise sponsors exactly how many patients match their clinical trial criteria.

Medical Writing and translations

Medical Writers have medical, pharmaceutical and life science backgrounds and are experienced in producing high quality Phase I–IV clinical documentation across a wide range of therapeutic areas that strictly adhere to ICH-GCP guidelines and local regulatory requirements. We understand the importance of communicating the details clearly, concisely, and accurately. Our document preparation process involves experts from Biometrics, Regulatory and Medical Affairs who are readily accessible for review and feedback and proactively provide solutions. The input of our team ensures that our client's key messages are medically and scientifically sound and acceptable to the clinician and researcher alike. Our documents undergo rigorous quality assurance review before delivery to our clients.

Medical Writing Projects include:

  • Clinical development plans
  • New drug Applications
  • Clinical Study Reports
  • IMP Dossiers
  • Clinical study protocols and amendments prepared to ICH-GCP
  • Subject information sheets and consent forms
  • Investigator's Brochures
  • Benefit/risk assessment reports
  • Pre-FDA meeting briefing documents
  • Informed Consent Documents
  • Annual Clinical study Reports
  • Periodic Safety Update Reports (PSURs) and other pharmacovigilance documents.
  • Integrated Summaries of Safety and Efficacy (ISS/ISEs)
  • Package inserts, patient information leaflets
  • Summary of product characteristics

  • Our Translation team consists of native speakers with many years experience in translating all documents necessary for the performance of clinical studies, such as:
    • Submissions to ECs/IRBs and health authorities
    • Correspondence
    • Protocol synopses
    • Protocol
    • Subject information sheets
    • Medical reports
    • Abstracts
    • Patient instructions
    • All other study related documentation