Services

IPHARMA provides full cycle of clinical development from early phase trials to registration and post-marketing PV.

Study documentation

• Clinical trial program development

• Clinical trial documentation development (IB, Protocol, ICF, Patient Materials)

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Regulatory Submissions

• Clinical Trial Insurance

• Registration dossiers submission

• Clinical Trial Application to RA

• Import/Export licenses

• Clinical trial documentation consideration monitoring

• Legislation amendments monitoring

• Legal analysis

• Study documents translation management and notary certification

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Project management

• Site and Investigator contract development

• Payment schedule development

• Training program and materials development

 

Clinical Monitoring

• Site identification and feasibility

• Site qualification, initiation, monitoring, and close-out visits

• Oversight of communication with Local Ethics Committees (approvals and notifications)

• Collection of essential documents and TMF maintenance

• Source data verification, CRF review, and query resolution and tracking

• Tracking of enrollment, subject progress

• Tracking of protocol deviations

• Communication with clinical sites

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Medical monitoring

• Medical monitoring and support to clinical sites and project teams

• Interfacing with Data Safety Monitoring Boards

• Interfacing with the Sponsor’s medical department

• SAE reporting, AE listings, and laboratory alert and protocol deviations review

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Pharmacovigilance

• Safety plan development

• Safety precautions

• SUSAR Report Preparation

• Post authorization pharmacovigilance

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Data Management and biostatistics

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Depot and logistics

• Depot coordination and investigator drug recording

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Central and bioanalytic laboratories

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Quality Assurance

• Trainings

• Audits