Advice on and preparation of Study Protocol design, Investigator’s Brochure.
Subject’s Information and Informed Consent Form development and translation.
Preparation of a complete trial documentation needed for submissions to The Central Register of Clinical Trials (CEBK) and Independent Ethics Committee (IEC) essential in initiating a clinical trial.
Investigative site selection.
Study Contract preparation and negotiation with sites.
Investigator’s Meetings / Study initiation.
Provision of a clinical trials monitoring services according to standard operating procedures (SOPs).
Clinical Project Management.
Clinical Site Coordination and Management.
Assistance to patient recruitment process.