About us

The PMs of start-up have as their objective to close the feasibility both logistically, operationally and economically of the studies promoted by the industry. Among their activities we can find:

• Validation of regulatory and ethical aspects of the project.
• Feasibility analysis at the center and structuring of the trial circuit.
• Cost estimation and budget negotiation with the Industry and CROs.
• Regulatory documentation management.

• Researcher Advisory.
• Regulatory and Ethics Roadmap Validation.
• Project Management.
• Cost Estimation and Budget Negotiation.
• Policy Contract.
• Monitoring of Trials and Clinical Studies.
• Regulatory Submission and Trial Monitoring.
• Agreements with Suppliers.
• Data Management and Supervision of VF (Pharmacovigilance).
• SCREN Platform (Emphasize, only pediatric unit within the SCREN platform).

• Recruitment support.
• Scheduling visits with patients and center services.
• Nursing tasks.
• Processing and sending samples.
• Supplier management.
• Investigator's archive.
• Data entry.
• Activity registration in Fundanet.
• Monitoring follow-up.

• Gestió de contractes i esmenes.
• Seguiment de càrrecs econòmics.
• Gestió de finançament de projectes.
• Seguiment d'activitat i facturació.
• Pagament a investigadors, serveis i hospital.

Within the Research Unit there is a quality reference that manages all aspects related to the activities described:

• UAC quality plan.
• Training of UAC and researcher staff.
• Preparation of audits and inspections.
• Supervision of compliance with GCP and applicable regulations.
• Security.