Our medical qualified personnel are able to offer a range of pharmacovigilance services to support your product development program.

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.

Pharmacovigilance Overview

Datapharm Australia is a full-service CRO with a dedicated Pharmacovigilance Team that offers safety services to Sponsors for both Clinical Trials and Marketed Products.

Key services provided for Clinical Trials include:

• Develop a project-specific Safety Management (Pharmacovigilance) Plan
• Process and conduct medical review of all serious adverse events (SAEs)
• Prepare case narratives for SAEs
• Monitor all adverse events (AEs) for safety issues/trends
• Prepare submissions to regulatory authorities and HRECs, including CIOMS and MedWatch forms
• Prepare Annual Safety Reports for HRECs
• Report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the TGA within expedited reporting timelines
• Report significant safety issues (SSIs) and urgent safety measures (USMs) to the TGA within expedited reporting timelines

Key services provided for Marketed products include:

• Develop safety data exchange agreements (SDEAs)
• Collect, process and conduct medical review of all adverse drug reactions (ADRs)
• Prepare submissions to regulatory authorities and HRECs, including CIOMS and MedWatch forms
• Report serious adverse drug reactions (SADRs) to the TGA within expedited reporting timelines
• Report significant safety issues (SSIs) and other safety issues (OSIs) to the TGA within expedited reporting timelines
• Monitor each product for safety issues/trends
• Conduct literature searches
• Maintain global safety databases
• Provide annual pharmacovigilance training to Sponsor staff
• Ensure the Sponsor complies with all pharmacovigilance requirements as stipulated by the TGA
• Conduct internal audit of Sponsor
• Submit Periodic Safety Update Reports (PSURs) to regulatory authorities
• Submit Development Safety Update Reports (DSURs) to regulatory authorities
  

Contact Datapharm Australia today on +61 2 9719 2800 for all your Pharmacovigilance needs!