Protocol Development

We will assist in the preparation of all essential Trail Documentation namely;

Protocols, informed consent documents, – trial master files, – clinical study reports – Standard Operating Procedures

  • Evaluation, review, setting-up and implementing QM systems in client companies, including writing or support with writing SOPs
  • Independent full or partial QM or QA coverage of client companies who need additional resources in QM/QA
  • Definition of and/or execution of QM and auditing plans for clinical studies