Essjay Solutions have access to a large network of experienced medical writers and can provide and manage your pharmacovigilance report writing, including PBRER, DSUR and RMP reports. Whether you require a section of a report to be managed and written or an entire report, we are able to offer assistance. We are aware that requirements will vary according to the needs of your business and we can provide highly professional medical reports written and delivered within tight deadlines. Our medical writers have extensive knowledge and experience and can relate this to whichever report has been commissioned.
We are able to provide written PBRER reports to enable your company to deliver a comprehensive critical review and analysis of new medical products being launched after approval periodically or on a regular basis. We have extensive knowledge and experience in writing PBRERs as well as medical product benefits vs risks analysis, which is required as part of the new PBRER format.
Essjay Solutions are also experienced in writing DSUR reports in relation to clinical trials and studies. We can provide you with a DSUR report to confirm that risks to those testing the drugs are being managed properly.
We offer RMP report writing services which is especially relevant as older products now require an RMP. At the time a new drug is approved, safety information relating to the drug is generally quite limited as only a limited number of people have been exposed to it during clinical trials and studies. The drug will have a positive benefit to risk ratio for specific types of people within a certain timeframe, and there will be various risks or possible side effects indicated by the study. When new risks are identified after the drug has been authorised due to more exposure to the drug by more people, it is necessary for the drug manufacturer to focus on pharmacovigilance activities to re-evaluate the safety of the drug and the RMP report covers this, including evaluation information and implementation of risk management strategies.