Medical Monitoring

Jubilant Clinsys Inc.’s global team of medical monitors offers the following services as part of our full clinical trial management. Individual services can also be contracted.

• Protocol/Synopsis development and/or review

• CRF development and/or medical review

• ICF medical review

• Therapeutic area and Protocol training for study teams

• Create Medical Monitoring Plan (MMP)

• Medical Monitoring

• Medical Resource and Support to Sites/Team/Sponsor

• Review of Inclusion/Exclusion Criteria

• Review and resolution of protocol issues

• Review of Data Listings and out of range/alert Laboratory Parameters

• Review of ECG reports

• Medical review of Coding:

• Adverse Event & Concomitant Medications

• Medical Data trending

• CSR preparation and medical review