Clinical Trial Management Service

Product Details

Excellence in ExecutionClinical trials require the use of human subjects and can severely impact the safety and well-being of the participating subjects. Success or failure of clinical trials can also severely impact large amounts of capital. For those performing the trial, the proper management of clinical trials is crucial.The clinical trial execution process at Ethicare involves coordinating people and resources, as well as integrating and performing all study-specific and needed activities in accordance with the study protocol and the project management plan.Ethicare's Clinical Trial Management services include:Setting up study-specific procedures and documents, such as: Feasibility questionnaires Site assessment and identification plan Monitoring plan Patient information leaflet and informed consent documents Patient recruitment plan Patient retention strategy Trial master file (TMF) Investigator Site Master File Contract negotiation and implementation Grant management Selection and coordination of: Central laboratories Investigational medicinal product logistics Data Monitoring Committee Training for study specific-procedures and underlying regulatory requirements to all involved stakeholders.Coordination of all study-related activities in all participating sites and between all involved stakeholders.Organization of meetings, e.g. investigator meetings.Management of Vendors and External PartnersGlobal clinical trials usually involve many different parties and vendors. The Ethicare Clinical Trial Management team provides a pivotal contact to all involved parties, such as:Central laboratoryInteractive Voice Record Systems (IVRS)Investigational medicinal product and other material providers and logistic companiesData Monitoring CommitteesMeetingEthicare's Clinical Trial Management team can organize meetings for your trial, such as:Monitor meetingsData Monitoring Committee meetingsWe will reconcile all needed presentations and material for each meeting. Most of the presentations will be conducted by our experienced team members with utmost professionalism.Trial Master FileRegulations require a trial master file (TMF) to be created and maintained for a clinical trial. Ethicare compiles and files all trial essential documents and information in a coherent format to enable your own ease of access and ready availability for audits and regulatory inspections. TMFs can be created and maintained as paper only.Ethicare's Clinical Trial Management team tracks and reviews each document and can provide clinical monitors and other parties with comprehensive reports on outstanding documents, inconsistencies between the documents and any other helpful information.At project closure, the TMF will be transferred to your preferred final archiving location accompanied by a complete and comprehensive table of contents and inventory of all documents and binders to facilitate future access.Contract and ManagementEthicare has good experience with all types of study-related contracts in various trial types, such as:Investigator / hospital / sponsor clinical trial agreementGeneral practitioner (GP) / sponsor clinical trial agreementHospital pharmacy / sponsor clinical trial agreementCentral laboratory / sponsor / CRO clinical trial agreementLocal laboratory / sponsor / CRO clinical trial agreementOther vendors clinical trial agreementsPatient reimbursement agreements