Genelife Clinical Research have created an infrastructure that is based upon some of the most experienced program, project managers and seasoned investigators who can smoothly guide any clinical trials project from the bench to the bedside with unparalleled speed. Genelife uses Project Managers who have broad experience in the conduct of complex clinical trials, a key element to study success. Additionally, we believe, that the Project Manager’s experience with the therapeutic area being studied is very important. Genelife Clinical Research’s Project Managers are supported by well-defined, time-tested processes to ensure the completion of clinical trials with limited time and budget. In the specific case of clinical end point ANDA programs, the primary objectives is to make the process as resource-efficient and cost-effective as possible, while increasing the likelihood of a successful outcome.
Study & Site Feasibility Analysis (SFA): Genelife Clinical Research has feasibility which works under Project Management Team. This team understands the objectives of the study and provides the solution to main question of project like what to be done; how to be done; at what cost; in what time. During site feasibility we emphasize on site not only with high disease prevalence but also with clinical research supportive environment. Clinical Research supportive environment is very important aspect for physician referral and it is not considered most of the time.
Project Planning (PP): In Genelife Clinical Research model we have divided Project planning in two major parts. In 1st is for initial phase is for training and performing initial activity like feasibility. After receiving the feasibility reports we develop plans like risk management plan, communication plan, QA plan, safety plan, monitoring plan, Data management Plan, SAP plan etc for stating how to complete a clinical trials within a certain time frame, usually with defined stages, and with designated resources. In totality the plan will include setting quantitative objectives, identifying deliverables, identify & manage foreseen and unforeseen risk, overcome bottleneck planning the schedule and making supporting plans.
Project Management & Commencing: Once a project moves into the Execution Phase, the project management team and the necessary resources to carry out the project should be in place and ready to perform project activities. The project team handover the activities to different departments and start analyzing the progress of work.
Monitor and control the process against the plan for performing the process and take appropriate corrective action. The purpose of Project Monitoring and Control is to provide an understanding of the project‘s progress so that appropriate corrective actions can be taken when the project‘s performance deviates significantly from the plan.
Effective project management is a key element to study success