Every phase of our clinical development programme achieves a complete picture because of its strategic Project Management expertise
The key player of the highly competent COD project management team is the Project Manager who coordinates the following functions related to the study execution seamlessly
Timeline
2020
Feasibility (rapid PI identification in line with protocol)
We analyze, summarize and systematically present an executive summary with Investigators feedback on feasibility of conducting the proposed study with all supporting facts and information which helps in optimal development of your clinical research program.
Site selection, Site start up activities
Identification of potential site and achievement of first patient enrollment are key activities for a startup. However to facilitate these activities, it is crucial to perform appropriate site selection, trial documents submission to regulatory authorities, contract and budget execution, vendor approval and setup, site initiation visit, thorough training of all the teams for protocol and regulatory compliance and finally first patient enrollment.
IP handling
Ensuring Investigational product storage follows the protocol guidelines at dedicated IP storage location with secure and access control to authorized personnel only. We maintain throughout tracking of entire process beginning from receipt of IP at our facility, arranging shipment of IP to sites cleared for SIV from QA, verification of IP accountability at site level and overall IP reconciliation at study level.
Patient recruitment/retention strategy (Root cause analysis to minimize drop outs)
Slow recruitment and patient withdrawal are the fundamental reason(s) for the failure of a clinical trial, which, when prevented on time with accurate mitigation plans results in successful completion of the study within the set timeframe as per the client expectations
100% source data verification
Our 100 % source data verification approach ensures highest level of regulatory and protocol compliance and also guides an informed decision on selection of the monitoring approach.
PK sample handling (Training for PK sample preparation kits)
We take maximum adherence to study protocol and regulatory guidelines with accurately define procedures. This in turn helps optimize bioanalytical procedures so that reliable results are obtained in clinical studies.
Study close out ( Complete resolution of queries related to Adverse events & document archival)
We have a well-defined study close out process with properly designed checklists for completion of activities including pre-visit preparation, resolution of outstanding issues, verification for completeness of study and patient files, shipment of used and unused IP, plan for the unresolved AE follow-up, close out notification to EC and lastly collection, consolidation and packing of study files for archival at the designated facilities in line regulatory requirements.
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Since its inception in 2017, COD Research has been achieving enviable milestones, opening new avenues in the field of clinical research.