Management of Clinical Trials

 

Investigators database with higher recruiters and black lists
Organizing and conducting comprehensive Investigator Meetings for multicentric trials
Mandatory trial documents verification
Creation and translation of study related documents
Medical advisory for CRF design
Investigator/Institution contracts negociation
Import/export/customs clearance and logistics of study related materials and drugs
Obtaining of Ministry of Health import license for IP, materials and trial devices
Site initiation, monitoring and closing
Investigator training on protocol, IVRS, EDC and laboratory techniques
Queries management for paper and EDC trials
Assessing protocol compliance and data integrity
Management of patients' data introduced using various pocketPC and PDA software
SAE and medical support 24/7 for investigative sites
Independent consultancy for audit
External audit of sponsors' sites and vendors, according to the GCP, GDP guidelines
Site preparation for inspections
Archiving of study documents for the required period of time
Succesfully proven patient recruitment methodologies