Comprehensive Phase I Through III Services
Clinical Trial InitiationFEASIBILITY ASSESSMENTIdentification and assessment of investigators and sites Pre-study visits Selection of investigators and sites Investigator and site contract negotiation REGULATORY APPROVALSInformed consent preparation Insurance carrier identification and contract negation Collection of regulatory documents Application for clinical trial authorizations Obtaining regulatory approvals from Health Ministry and Ethics Committee ENROLLMENT PROGRAMDesign of pre-screening program Study promotion Management Pre-screening program management QA of pre-screening program MISCELLANEOUSInvestigational Medicinal Product Importation Translation of required documents Clinical Trial ManagementGENERALStudy Coordination Budget and timeline management Develop study procedures and tracking tools Supervise CRAs Facilitate sponsor communication and decisions Data safety monitoring board organization Coordinate data management, biostatistics and clinical operations TRAININGSConduct study initiation meetings Organization and participation in investigator meetings Investigator and site personnel training Produce study in-service materials and manuals CLINICAL TRIAL MONITORINGRegular monitoring visit Tracking source documents Tracking IMP supplies and inventory management Query management and resolution SITE MANAGEMENTSite Selection Overall site management Site close-out DOCUMENT MANAGEMENTSet-up and maintenance of study files Archiving of study files Set-up and distribution of site files LABORATORY MANAGEMENTSelection of clinical laboratory facilities Clinical laboratory contract negotiation Ongoing liaison with clinical laboratories SAE MANAGEMENTMedical review of SAEs SAE narrative preparation Regulatory reporting of SAEs Notification of reportable SAEs to site and ECs SAE data management Biometrics*DATA MANAGEMENTCRF design Database design and programming Data coding Validation Query management Data archiving BIOSTATSTICSStudy design and consultation Assistance with protocol development and verification of CRF design Medical Writing and Regulatory Affairs*MEDICAL WRITINGClinical protocols Study Reports REGULATORY AFFAIRSRegulatory strategizing Interpretation of FDA/ICH regulations and guidance Planning and facilitation of Committee meetings Preparation of Committee meeting materials FDA liaison meeting facilitation EGeen can provide a turn-key solution for clinical trials including all functions listed above. Some of the functions under the services marked in * may be performed by our preferred partners. There are Standard Operating Protocols in place for seamless collaboration between the Sponsor, EGeen and its partners, and EGeen will coordinate and responsible for both its activities and partners’. |