Drug Safety & Pharmacovigilance
A reliable team for reliable services
Pharmacovigilance is incredibly important – and takes incredible skill to do well. Let Cmed help you ensure your trial’s safety, conducting safety management from clinical development to post-marketing. Our expert team provides a comprehensive global approach to safety reporting, either as part of a full service solution or as part of your team. Years of experience across multiple therapeutic areas; global reach; and in-depth regional knowledge ensure success in your drug safety efforts. With Cmed, you can focus on other aspects of your product development, knowing that we’re monitoring your patient safety and risk/benefit profile.
Pharmacovigilance activities include:
> Serious Adverse Events occurring during a clinical trial are notified to
Datapharm, using trial specific SAE forms. We fill in the blanks and follow
up on missing information.
> All SAEs are entered into a trial-specific area in our ARISg™ database. Regular
listings can be provided to the client as requested.
> A registered medical practitioner is available to review safety information and
respond to any questions raised by members of the team.
> A medically qualified person reviews all SAEs for relationship to study
medication and expectedness according to IB or product information.
> We write safety narratives and follow them to resolution.
> SUSARs for medications or devices reported to the regulatory authority(s) as
required (TGA, FDA, EMA) – with follow-up.
> Experience with DSURs and PSURs.
> Submissions to the authorities.
> If there is a DSMB constituted for a clinical trial, we notify all SAEs and
conduct follow up.
> A 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.
Praise from our customers
“Our sincere thanks for an amazing management of submissions – no hiccups, all on time, very smooth. Thank you!”