© 2019 IPHARMA

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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)

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

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

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

Pharmacovigilance

  • Safety plan development

  • Safety precautions

  • SUSAR Report Preparation

  • Post authorization pharmacovigilance

Data Management and biostatistics

Depot and logistics

  • Depot coordination and investigator drug recording

Central and bioanalytic laboratories

Quality Assurance

  • Trainings

  • Audits