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.
Senior team member
Pharma Clinical knowledge
Pharma Clinical connections
Direct team interactions
High level of sponsor control
FTE-based pricing model
Flexibility of resources
Short allocation time
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.
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.
Interaction with Vendors
Identifying suitable vendors for the study and setting up expectations: Pharmacovigilance services, Data management, Central Lab, IMP logistic services, etc.
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.
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.
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.
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.