We have a unique CRO profile providing unique and innovative dual expertise combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
What We Do
Let’s start with the basics:
The successful execution of a clinical trial means the project is finished on time, on budget, and has a high level of quality. It only figures then that these objectives should be clearly defined before initiating any project.
The main purpose of planning is to anticipate all possible actions that will take place throughout the project. The complexity of today’s trials makes such a diagnosis for each aspect of the study (in order to set realistic project objectives) imperative.
Regulatory: trial legislation and requirements to ensure patient safety are changing everyday, mainly in emerging regions.
Clinical trials logistics: study or comparator drug importation and regulation, collection, analysis and management of biological samples need to be taken into account which makes a detailed plan necessary that covers supplies, storage, and distribution.
Legal Agreement: contracts with investigator’s sites (hospital, pharmacy) under local regulations need to be negotiated.
Investigational sites: Identifying the right sites to conduct clinical research is critical. Never underestimate cultural differences and language barriers.
Technology: Adoption of new technologies and network capabilities very often varies from country to country.
Protocol design: the standard treatment in countries may be different. The study protocol must take into account product reimbursement issues and patient comfort to avoid a low recruitment rate.
Define the critical path: Popsicube-Fovea with is large experience and senior staff has developped a project template, that contains high-level details and strategies ensuring repeated successful planning—achieving study goals in the shortest amount of time.
Successful businesses have project plans. They also have Project Managers to carry out those plans.
A project plan should include the following components: clear objective, timelines, defined resources, task responsibilities, communication plan and tools, associated risks and plan B anticipation.
Conducting clinical trial feasibility and study sites selection is both an art and a science. The science comes from the disease area, study design, types of patients etc. The art comes from collation of and reliance on the information as well as presenting the real information.
Feasibility assessment is an investment to ensure a good study.
Deciding whether to work with an investigator or not and identifying challenges and probable solutions