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.