Your Expert Partner

Clinical Research

 

Clinagil provides selected services within the field of clinical research.

 

Study planning. Development of study design and protocol with respect to most time and cost effective approach to achieve the study objectives. Special experience within bioequivalence and documentation of therapeutic equivalence or non-inferiority.

 

Study preparation. Screening and identification of study centres and investigators. Contract negotiation with selected investigators. Writing of investigators brochure.

Regulatory requirements. Studies with an Investigational Medicinal Product (IMP) must comply with the EU clinical trial directive. Clinagil can prepare and submit the complete documentation package for health authority and ethics committee approval within EU.

Study conduct. Training of study staff and monitors. Monitoring and co-monitoring on selected basis.

Quality Assurance. Study documents and site audit to fulfil and document EU GCP requirements of clinical trials and laboratory investigations. Audit reports and   certificates will be issued.