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DADA Consultancy (DADA) is a highly specialised, independent consulting agency that offers a wide range of international clinical services. Our clinical services department is built around professionals who exclusively focus on clinical services and regulatory requirements. Our definition of a service is to help our customers to identify their clinical development goals and to develop a plan that will meet the customer needs. We can offer a wide range of tailor-made international clinical services in the field of human and veterinary medicinal products, including:

  • Writing clinical and non-clinical overviews
  • Coordination of SmPCs with clinical and non-clinical overviews
  • Writing literature parts of Module 4 and Module 5
  • Selection of CROs and monitoring of clinical studies
  • Auditing clinical studies and CRO’s
  • Writing clinical study reports
  • Evaluation of clinical study reports
  • Troubleshooting in case of failed biostudies
  • Writing clinical trial applications to ethical committees and local authorities
  • Writing Investigational Medicinal Product Dossier
  • Giving advise on study designs for human and veterinary products
  • Writing clinical protocols, investigators brochures and other study specific documents
  • Medical review
  • Preparing scientific advice questions and accompanying customers to scientific advice meetings
  • Writing feasibility studies
  • Writing biowaivers
  • Writing justification for lack of incurred sample reanalysis

Our focus is on meeting Your goals and to provide tailor-made solutions for clinical topics.  Our clinical services are described in detail on the following pages.