Being a healthcare professional led company, patient safety is our passion and is always at the heart of what we do
We can design customised solutions and strategies to suit your Pharmacovigilance needs. Our team of specialist Pharmaceutical physicians and experts have the right proficiency and experience to provide quality, compliant and cost-effective answers to your drug safety problems. We can assist as an extended arm of your drug safety teams or can work as an integral part; on one off projects (like writing a PSUR) or as a trusted partner on long term and on-going projects.
Drug safety is a complex and evolving science – if ever you need a trusted partner, we would be delighted to help and assist.
High quality services that we can provide:
- Medical Monitor/Clinical Research Physician
- Medical review of adverse event reports
- Causality, seriousness and expectedness assessment
- On-going evaluation of benefit/risk ratio
- Signal management
- narrative writing
- Safety database and QPPV by arrangement
- PV related documents such as PSURs / PBRERs, RMPs, PSMF, PV SOPs and DSURs
- Literature search, analyses and ad-hoc benefit-risk assessments
- Patient support programmes
Need a second pair of safe hands or a trusted partner to help and assist with your drug safety needs?
Case Study 1
A company required an urgent signal evaluation report for the key indication of a complex medicinal product, requiring extensive knowledge of cardiac physiology.
The expert HCP-lead team at My Medical Department collated and reviewed all the cases in the company’s safety database, supplemented by a systematic literature-based analysis of similar events and evaluation of the available pre-clinical data. Due to the extensive preclinical expertise and clinical knowledge of our team, we were able to advise the client on the necessary updates to their Risk Management Plan.
- Rapid delivery of signal evaluation report in a complex medical field
- RMP update ensured the ongoing positive risk-benefit-balance of the product.