Our medical qualified personnel are able to offer a range of medical monitoring and pharmacovigilance services to support your product development program.
Medical Monitoring for Clinical Trials
Datapharm can provide an Australian-registered medical practitioner to act as Medical Monitor during Clinical Trials. The function of the Medical Monitor is determined by agreement with the client and can include response to site questions about subject eligibility or other safety or medical issues arising at commencement or during the course of a clinical trial. The Medical Monitor may be required to be a member or to otherwise participate in DSMB meetings to discuss safety issues arising during a clinical trial.
Pharmacovigilance Services for Clinical Trials
Datapharm has a trained Pharmacovigilance team who are able to process adverse event and other safety information during a clinical trial. A registered medical practitioner is available to review safety information and respond to any questions raised by members of the team. Pharmacovigilance activities include:
- Serious Adverse Events occurring during a clinical trial are notified to Datapharm using trial specific SAE forms. Missing information is requested from site and the event is followed-up.
- All SAEs are entered into a trial specific database. Regular listings can be provided to the client as requested.
- A medically qualified person reviews all SAEs for relationship to study medication and expectedness according to IB or product information.
- Safety narratives are written and followed up until resolution of event.
- SUSARs for medications or devices are reported to the regulatory authority(s) as required (TGA, FDA, EMA) and followed-up.
- If there is a DSMB constituted for a Clinical Trial then all SAEs (and follow-up) are notified to the chair.
- The medically qualified person reviews all adverse events in the clinical database at regular intervals and reports any safety issues/trends to the sponsor and the DSMB chair.
Pharmacovigilance for Marketed Products
Datapharm Pharmacovigilance Services are available for products marketed in Australia and include receipt and monitoring of spontaneous adverse event reports and notification to the TGA if necessary. The Pharmacovigilance team will review any reports of SAEs occurring outside Australia and conduct regular literature review and notify the TGA as required.