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Pharma Clinical - Global Clinical Research Capabilities Products

Pharma Clinical - Global Clinical Research Capabilities

Global project Management Pharma Clinical’s experienced project managers (PM) are the key person responsible for the management of a global clinical study. The PM is responsible for the setting up and the study as well as for sufficient drug supply, training and communication of site team members as well as ensuring that all study milestones will be met, as agreed with the sponsor.
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Advice on Patient Recruitment Strategies Based on the specific indication and study population required and according to their net of local people and KOL, Pharma Clinical provide the sponsor with a recruitment strategic plan identifying the most potential countries and sites to be involved in a specific clinical study.
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Site Selection & Feasibility Based on the specific indication and study population required they perform a detailed feasibility process, which accordingly provide their recommendations regarding the most suitable and promising sites.
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Study Set-Up The study set up period is one of the most important phases. During this period the study strategy and plan should be defined and carried out. This includes: monitoring plan, allocation of providers, (such as central laboratory), sites identifications, sites agreement negotiation, CRF design, protocol finalization, regulatory submission process and others. A high-quality planning process will avoid many issues during the active phase of the study.
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Monitoring Activities Their dedicated qualified CRAs perform several visits at each site including: initiation visit, onsite monitoring visits and close out visits- end of study visit.
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Quality Processes These are embedded in Pharma Clinical Group delivery model. Their dedicated QA manager supports the project teams to ensure that established processes meet the needs of the project and that all the regulatory requirements are met. This quality approach is underpinned by an audit program.
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