Our world-class medical team comprises experienced industry physicians who offer the complete range of medical services, providing support throughout the drug development programme.

We have extensive clinical trial experience in pre- and post-approval trials. Our expertise covers writing and editing all types of documentation for internal company use, regulatory submission, publication and marketing support.

Medical Writing

Our team includes members of the American Medical Writers Association (AMWA) and the European Medical Writers Association (EMWA). They’re experts in all medical document writing, including study reports, regulatory submissions, protocols, development safety update reports (DSUR), publications, training and marketing materials.

Supporting the Sponsor’s Medical Function

  • Representation of the sponsor’s medical function with investigators and health authorities

  • Pharmacovigilance physician and product safety expert
  • Participation in safety advisory boards

Support for Clinical Trials

  • Medical input to protocol design

  • Medical support to clinical research associates

  • Response to medical questions

  • Evaluation of laboratory results and other clinical parameters

  • Visiting sites to solve medical issues

  • Responding to ethics/regulatory medical questions

  • Contributing to internal safety-monitoring groups

  • Medical reviews of patient profiles and data listings

  • Final study report reviews

Medical Participation in Pharmacovigilance Activities

  • Reviewing safety profile and risk/benefit analysis

  • Review of serious adverse events (SAE)/pharmacovigilance reports

  • Review of adverse safety update reports (ASUR) and periodic safety update reports (PSURs)

Medical Marketing Support

  • Comprehensive medical information services

  • Literature analysis and evaluation for marketing purposes

  • Production of marketing support and training materials

  • Writing or reviewing manuscripts for publication

  • Sign-off of advertising copy

  • Support of scientific service (medical information)

Regulatory Documents

  • Working with our pharmacovigilance team to provide the scientific/medical service post-marketing authorisation.

Get In Touch

Our team is ready and willing to support your medical needs.

To discuss your specific project requirements, contact us today.