Services
We can support you with many activities
Vigilance Operations
Do you need assistance with ad-hoc procedural documentation creation, gap-analysis or a completely process overhaul?
Or may be you want to implement a new database, create follow-up questionnaires, or manage a new business unit integration?
We have extensive experience in all of these.
We can also be your UK QPPV (Qualified Person for Pharmacovigilance) representation, or assist you with interim senior-management oversight to preserve team stability during transition periods.
We understand the challenges from outsourcing to a third party and can create a vendor-oversight strategy for you.
Safety Analysis
Having worked in many therapeutic areas and with broad ranges of products over the years we approach each data-set with open minds and critically examine it from multiple stakeholder's perspective.
Whether you need a:
- Safety Signal Evaluation performed,
- An Aggregate Report drafted or QC'd,
- A review of clinical studies data or an integrated safety summary;
- An independent perspective on a safety issue,
We have the global expertise necessary to support you locally.
Proactive labeling-development and -management strategies are equally important and and we can assist you with these too.
Drug Safety Training
The world of Pharmacovigilance is intricate and vast.
Many healthcare and research industry professional lack the depth of knowledge to anticipate Regulatory or process hurdles ahead of them, nor do they have the time to investigate the historical precedents and regulations.
Yet, they are expected to show global compliance, and create proactive risk-management strategies..; quite a challenge!
We offer comprehensive drug-safety training with a stakeholder-drive approach. Do you wish to..
- Connect the dots of Regulatory expectations?
- Have a Sales force briefed before a launch or inspection?
- Develop a team’s expertise on methods of analysis?
- Adapt to digital-health and IoH/IoT?
You can tap into the breadth of our cumulative experience.
Auditing and Consulting
Do you know what the top major findings are in Regulatory Pharmacovigilance inspections?
We will work with you to ensure that you never have to find yourselves in those data tables!
We can audit any part of your pharmacovigilance system (or your vendor's) and assist with actual Regulatory inspections (please note that currently unless for special cases these are conducted remotely).
We also provide extensive consulting services tailored to your needs.
Whether it is for a due-diligence piece, developing data-extraction or -integration processes, a safety-data-agreement creation, driving an adjudication committee, a gap-analysis, right through to supporting your end-of-phase III submission and meetings, we have the knowledge to adjust quickly and efficiently to your product and infrastructure.
Our Moto is.. "Safety by design!"
