Docleader S.r.l. is able to assist and support pharmaceutical companies and institutions in the conduct of clinical and drug trials, epidemiological and observational studies. The company offers complete support, from the design of the study to the production of reports on the final results of the trial, with in-house project management.

Services offered in this sector include:

• Design of clinical trials
• Definition and drafting of study protocol
• Design and preparation of Case Report Forms (CRF) in hard-copy or electronic (e-CRF) format
• Selection of centres
• Organisation and management of Investigators’ Meeting
• Management of ethical/administrative procedures with individual centres
• Commencement and on-site clinical monitoring or remote monitoring (e-monitoring) of the clinical trial
• Data Management
• SAS and SPSS development applications
• Sample size calculation
• Production of randomisation lists
• Design and development of electronic databases
• Ongoing data entry
• Remote data entry and electronic data transmission
• Statistical Analysis Plan
• Statistical processing
• Statistical reports
• Integrated clinical reports

The main areas in which the company operates in this field are:
Cardiology, Oncology, Paediatrics, Haematology, Infectious Diseases, Pneumology, Orthopaedics, Anaesthesiology, Gastroenterology, Immunology, Rheumatology and Neurology