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On-Site Project Management

Pharma Clinical's unique on-site model for sponsors of all sizes provides flexible, personalized, on-site project management services to healthcare companies to meet their ever-increasing clinical evidence needs.

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Senior team member

Pharma Clinical knowledge

Pharma Clinical connections

On-Site Services

Direct team interactions

High level of sponsor control

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FTE-based pricing model

Flexibility of resources

Short allocation time

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Protocol Review

Comprehensive review of the protocol to ensure consistency, clarity and integrity of the study design. A risk-mitigation strategy is implemented with a focus on cost-effective solutions that reduce development cycle timelines.

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Protocol Feasibility

Assessment of possible suitable patient populations to meet the trial’s enrollment goals; making sure that study procedures are aligned with the standard of care; taking into account the availability of other treatment options.

Laboratory

Interaction with Vendors

Identifying suitable vendors for the study and setting up expectations: Pharmacovigilance services, Data management, Central Lab, IMP logistic services, etc.

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Budget Planning

Planning the whole study budget including site and investigator payments, CRO services, vendor costs, study supplies/equipment, logistics and courier costs, regulatory authority fees, etc.

Data on a Touch Pad

CRF Design

Collaborating with a Data Management provider to best design the eCRF to meet the study goals, reduce staff burden and to have the ability to export important reports for project oversight.

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Site Selection

Selecting the most suitable sites for the study by ensuring they have the required  facilities/equipment, a sufficient pool of patients and a site staff that is qualified and well experienced in the study indication.

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Project Management & Monitoring

Managing all operational aspects, including regulatory submissions, source data verification and monitoring activities, ensuring compliance with the ICH-GCP and regulatory requirements.

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