Patient Safety and Pharmacovigilance.
Pharmora can support patient safety in numerous ways. Some examples are below:
Safety Scientist / Safety Physician services
Pharmora-trained Safety Scientists and Safety Physicians can be nominated to support your projects and deliver services within your global patient safety teams at times of peak resource needs.
Regulatory interactions
Pharmora services include delivering pieces of work such as signal evaluations, safety summaries and clinical overviews to support regulatory interactions regarding safety topics.
Ongoing literature review
Pharmora can propose literature search terms and then review the outputs to identify new safety information on your products, either as an individual piece of work or as an ongoing service.
Medical monitors
Pharmora can provide medical monitoring services including MedDRA coding, seriousness and Sponsor causality assessments plus propose requests for follow up information for individual case safety reports (ICSRs) in clinical trials.
More
Contact us to find out more about our patient safety and risk management services.
Patient Safety and Pharmacovigilance.
Pharmora can support patient safety in numerous ways. Some examples are below:
Safety Scientist / Safety Physician services
Pharmora-trained Safety Scientists and Safety Physicians can be nominated to support your projects and deliver services within your global patient safety teams at times of peak resource needs.
Regulatory interactions
Pharmora services include delivering pieces of work such as signal evaluations, safety summaries and clinical overviews to support regulatory interactions regarding safety topics.
Ongoing literature review
Pharmora can propose literature search terms and then review the outputs to identify new safety information on your products, either as an individual piece of work or as an ongoing service.
Medical monitors
Pharmora can provide medical monitoring services including MedDRA coding, seriousness and Sponsor causality assessments plus propose requests for follow up information for individual case safety reports (ICSRs) in clinical trials.
More
Contact us to find out more about our patient safety and risk management services.
Challenges faced by clients
Click below to read about some of the challenges faced by our clients and the solutions Pharmora used to address them:
Challenge: Flexible safety team resource
During clinical development there are peaks and troughs of workload for the medical team. For example, when initiating recruitment there will be a great many eligibility queries to respond to; during peak recruitment there will be safety queries and data to review on an ongoing basis; and ahead of any milestones there will be peaks of data review. It takes a long time to recruit additional staff and train them to the suitable level therefore teams often use contract resource to fill the gaps.
Pharmora solutions
Pharmora has a stringent and comprehensive assessment and selection process and will only employ staff that fulfil these exacting requirements. Pharmora medical scientists are trained by an experienced safety physician and all training is led by the Chief Medical Officer (CMO), who was qualified as an educational supervisor by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of London. Suitable Pharmora safety scientists will be matched with the role and mentored to ensure they embed quickly and smoothly into the client’s team. Any upskilling or other training needs are managed by Pharmora, leaving the client only with the support they require. In this way Pharmora continues to provide an assured service, giving our clients the best of both worlds as we source the best talent, train them to the gold standard and provide excellent services through them to meet our clients’ needs.
Challenge: Flexible safety team resource
During clinical development there are peaks and troughs of workload for the medical team. For example, when initiating recruitment there will be a great many eligibility queries to respond to; during peak recruitment there will be safety queries and data to review on an ongoing basis; and ahead of any milestones there will be peaks of data review. It takes a long time to recruit additional staff and train them to the suitable level therefore teams often use contract resource to fill the gaps.
Pharmora solutions
Pharmora has a stringent and comprehensive assessment and selection process and will only employ staff that fulfil these exacting requirements. Pharmora medical scientists are trained by an experienced pharmaceutical physician and all training is led by the Chief Medical Officer (CMO), who was qualified as an educational supervisor by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of London. Suitable medical scientists from the Pharmora clinical development team will be matched with the role and mentored to ensure they embed quickly and smoothly into the client’s team. Any upskilling or other training needs are managed by Pharmora, leaving the client only with the support they require. In this way Pharmora continues to provide an assured service, giving our clients the best of both worlds as we source the best talent, train them to the gold standard and provide excellent services through them to meet our clients’ needs.
Challenge: Signal Evaluations
There are times when a number of evaluations is required in a short space of time, for example to defend the current label following health authority questions; as part of a regulatory submission; in the Periodic Benefit Risk Evaluation Report (PBRER / PSUR) for a newly licensed product or when signal detection methods change. At these times there is insufficient internal resource to cope with the number of evaluations and the client often chooses to outsource some of the work.
Pharmora solutions
Pharmora will assign suitably experienced pharmacovigilance physicians and safety scientists to work together to review the data and produce signal evaluation reports, using the client’s template as required. This could include performing literature searches and reviewing data from clinical trials in addition to outputs from the post-marketing database. Pharmora uses an established approach to assign factors to individual case safety reports (ICSRs) and summarises these in a standardised way to provide a transparent evaluation that would be reproducible in the future. If required Pharmora can also assist with drafting summaries of the safety data and developing key messages for different modes of communication, including with healthcare professionals, in the product label or for regulatory defence documentation.
Challenge: Signal Evaluations
There are times when a number of evaluations is required in a short space of time, for example to defend the current label following health authority questions; as part of a regulatory submission; in the Periodic Benefit Risk Evaluation Report (PBRER / PSUR) for a newly licensed product or when signal detection methods change. At these times there is insufficient internal resource to cope with the number of evaluations and the client often chooses to outsource some of the work.
Pharmora solutions
Pharmora will assign suitably experienced pharmacovigilance physicians and safety scientists to work together to review the data and produce signal evaluation reports, using the client’s template as required. This could include performing literature searches and reviewing data from clinical trials in addition to outputs from the post-marketing database. Pharmora uses an established approach to assign factors to individual case safety reports (ICSRs) and summarises these in a standardised way to provide a transparent evaluation that would be reproducible in the future. If required Pharmora can also assist with drafting summaries of the safety data and developing key messages for different modes of communication, including with healthcare professionals, in the product label or for regulatory defence documentation.
The founder of Pharmora, Dr Stephanie Jones, is an experienced pharmaceutical physician with a background in global patient safety, having worked in post-marketing safety and clinical development. She provides training, supervision and support to Pharmora Safety Scientists and Pharmora Safety Physicians in addition to running external courses on many safety topics.
