Pharmacovigilance medical writing is an essential component of our end-to-end pharmacovigilance system. Whether you’re looking to outsource individual medical writing services, or a comprehensive pharmacovigilance solution, you’ll do well to come to Tepsivo.
Those pharmaceutical companies who have entrusted the full management of their pharmacovigilance responsibilities to Tepsivo don’t need to worry about monitoring the medical writing obligations and what documents they’re supposed to put together, submit to authorities, and when. We have them covered.
And we can have you covered too. Just reach out for more info.
All aggregate reports you need, at the right time
Our customers know that we keep a close eye on what types of reports need to be prepared and when, meeting their ongoing regulatory obligations.
These can be aggregate reports such as a Periodic Safety Update Report (PSUR) / Periodical Benefit-Risk Evaluation Report (PBRER) required in Europe and some other countries of the world, or a Periodic Adverse Drug Experience Report (PADER) as required by the FDA in the US.
RMP writing and management
If you’re applying for a new Marketing Authorization, you may have to submit a Risk Management Plan (RMP). This is naturally part of the service that Tepsivo can provide under its full global pharmacovigilance solution.
As the years will go by, we’ll keep an eye on when the RMP may need to be updated, and we’ll manage that for you, including the preparation of the associated variation.
How do we do it?
With our overall focus on efficiency, we can always guarantee all medical documents are prepared quickly, with lower time effort (read lower cost), ensuring all relevant information is captured, and every legislative requirement being met in 100%, assuring the highest standard of quality.
When you submit a Tepsivo prepared aggregate report or other type of document, you know it won’t be rejected or sent back for a rewrite.
Why? In our global pharmacovigilance system, fully operated via our unique inhouse Tepsivo Platform, all relevant safety data and any pharmacovigilance related activities are always logged in one central place – that’s Tepsivo Platform.
Thanks to this innovative and currently unique, yet very simple, approach, we can easily eliminate all administrative and annoying work associated with pulling together source data for your medical writing and even worrying about different versions of reports or where the final documents are stored and maintained for updates.
All safety relevant information is always available for the MAH and any person in the pharmacovigilance system to see, all in the Tepsivo Platform. During retrospective review and signal analyses, all such data can be very easily linked with an individual signal report and the same applies to the regular aggregate report, such as PSUR. All the while eliminating endless hours behind acquiring the data and moving it to a place where it can be analyzed and then captured in one report.
Individual Medical Writing Services
Or do you have a specific need for an individual pharmacovigilance medical writing support?
Just let us know what documents you need to write up and we can manage that for you, as well.
Some examples can be:
✓ Periodic Safety Update Report (PSUR)
✓ Periodic Benefit-Risk Evaluation Report (PBRER)
✓ Periodic Adverse Drug Experience Report (PADER)
✓ Risk Management Plan (RMP)
And perhaps you have a need for medical writing in clinical trials? We can help with:
✓ Study Protocol
✓ Safety Management Plan
✓ Investigator’s brochures
✓ Informed Consent Forms
We can also perform specific on-demand research and report or article preparation.
Quick example of an ad hoc analysis is our investigation into a reported increase of ADRs of a blockbuster drug that made the news, but as our critical data analysis shows, is likely inconsequential:
“Analysis of the Potential Safety Signal” by Martti Ahtola
Let’s have a chat
Whatever your needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.