Consideration of the benefits and risks starts long before any humans are exposed to an investigational product. Pharmora can support your teams to develop a benefit-risk evaluation based on the data so far for your product and help you to plan the first in human studies accordingly.

Contact us to find out if we can help you by providing training for your teams as they plan their first human trials. We are expert at tailoring training for your precise needs and can support all of our training with follow-on mentoring services.

Consideration of the benefits and risks starts long before any humans are exposed to an investigational product. Pharmora can support your teams to develop a benefit-risk evaluation based on the data so far for your product and help you to plan the first in human studies accordingly.

Contact us to find out if we can help you by providing training for your teams as they plan their first human trials. We are expert at tailoring training for your precise needs and can support all of our training with follow-on mentoring services.

Pharmora employees have succeeded through our stringent set of selection and interview processes. This ensures our safety scientists and medical teams are of the highest quality. They are then trained and supervised by the Chief Medical Officer, who is a highly experienced pharmaceutical physician. We therefore provide an assured outsourced service, whereby any members of our team who work for you will continue to have the full support of Pharmora. This service is assured regardless of whether you need a specific deliverable from a Pharmora team or support by a nominated individual who will embed smoothly into your team for the duration of the project.

Consideration of the benefits and risks starts long before any humans are exposed to an investigational product and continues throughout the life cycle. Pharmora can support your teams to develop a benefit-risk evaluation and help you to plan the early clinical studies accordingly.

At any time during the product life cycle safety signals will be detected. These could be generated on a routine basis by the Patient Safety team or received as an alert by a regulator. Pharmora can support with the evaluation of these signals and can provide input into any regulatory interactions required to defend or amend the product label.

All products on the market in the EU and UK must have a risk management plan (RMP) and this is therefore a mandatory requirement in the submission of an MAA application. However, most companies begin drafting the RMP early in clinical development so that it is available for use when planning trials and can be refined so that it is perfect by the time of submission. Pharmora can support with RMP production at any stage in the product life cycle.

The results of a clinical trial are only as good as the data that they are based on. High quality data means a more reliable result and reduces the risk of regulatory queries and delays during review of marketing authorisation applications. Pharmora can provide a team approach to reviewing data from your clinical trial database. Alternatively we can provide nominated individuals who embed within your team to facilitate site interactions and address data queries.

The development safety update report (DSUR) was created as a mandatory requirement for any study with sites in the EU and is now expected by many other regions including the US. Although the majority of the report is standardised tabulations it is important to present the data and any updates to the product safety information in a transparent and neutral manner. The DSUR must provide sufficient information so that the regulatory agencies can understand the evolving safety profile, while being targeted only to the data that impacts on safety so any changes to the benefit-risk are not diluted by irrelevant details. Pharmora can support your team to draft the report and help you respond to regulatory queries arising from the data.

Pharmora can provide bespoke training in safety or clinical development for any stage in the product life cycle. This includes web-based or face to face training with a trainer experienced in the relevant subject matter, or developing resources for your teams to facilitate standardised high quality deliverables. Contact us to find out how we can support you.

Pharmora employees have succeeded through our stringent set of selection and interview processes. This ensures our safety scientists and medical teams are of the highest quality. They are then trained and supervised by the Chief Medical Officer, who is a highly experienced pharmaceutical physician. We therefore provide an assured outsourced service, whereby any members of our team who work for you will continue to have the full support of Pharmora. This service is assured regardless of whether you need a specific deliverable from a Pharmora team or support by a nominated individual who will embed smoothly into your team for the duration of the project.

Consideration of the benefits and risks starts long before any humans are exposed to an investigational product and continues throughout the life cycle. Pharmora can support your teams to develop a benefit-risk evaluation and help you to plan the early clinical studies accordingly.

At any time during the product life cycle safety signals will be detected. These could be generated on a routine basis by the Patient Safety team or received as an alert by a regulator. Pharmora can support with the evaluation of these signals and can provide input into any regulatory interactions required to defend or amend the product label.

All products on the market in the EU and UK must have a risk management plan (RMP) and this is therefore a mandatory requirement in the submission of an MAA application. However, most companies begin drafting the RMP early in clinical development so that it is available for use when planning trials and can be refined so that it is perfect by the time of submission. Pharmora can support with RMP production at any stage in the product life cycle.

The results of a clinical trial are only as good as the data that they are based on. High quality data means a more reliable result and reduces the risk of regulatory queries and delays during review of marketing authorisation applications. Pharmora can provide a team approach to reviewing data from your clinical trial database. Alternatively we can provide nominated individuals who embed within your team to facilitate site interactions and address data queries.

The development safety update report (DSUR) was created as a mandatory requirement for any study with sites in the EU and is now expected by many other regions including the US. Although the majority of the report is standardised tabulations it is important to present the data and any updates to the product safety information in a transparent and neutral manner. The DSUR must provide sufficient information so that the regulatory agencies can understand the evolving safety profile, while being targeted only to the data that impacts on safety so any changes to the benefit-risk are not diluted by irrelevant details. Pharmora can support your team to draft the report and help you respond to regulatory queries arising from the data.

Pharmora can provide bespoke training in safety or clinical development for any stage in the product life cycle. This includes web-based or face to face training with a trainer experienced in the relevant subject matter, or developing resources for your teams to facilitate standardised high quality deliverables. Contact us to find out how we can support you.

Pharmora employees have succeeded through our stringent set of selection and interview processes. This ensures our safety scientists and medical teams are of the highest quality. They are then trained and supervised by the Chief Medical Officer, who is a highly experienced pharmaceutical physician. We therefore provide an assured outsourced service, whereby any members of our team who work for you will continue to have the full support of Pharmora. This service is assured regardless of whether you need a specific deliverable from a Pharmora team or support by a nominated individual who will embed smoothly into your team for the duration of the project.

All products on the market in the EU, UK and many other regions must have a risk management plan (RMP) and this is therefore a mandatory requirement in the submission of a marketing authorisation application. However, most companies begin drafting the RMP early in clinical development so that it is available for use when planning trials and can be refined so that it is perfect by the time of submission. Pharmora can support with RMP production at any stage in the product life cycle.

The results of a clinical trial are only as good as the data that they are based on. High quality data means a more reliable result and reduces the risk of regulatory queries and delays during review of marketing authorisation applications. Pharmora can review the data to identify potential errors, raise queries and ensure they are addressed before closure. We can provide a team approach to reviewing data outputs from your clinical trial database, or we can provide nominated individuals who embed within your team to facilitate site interactions and address data queries directly.

At the end of every trial the regulatory agencies require a set of narratives for every serious or medically relevant adverse event. These come at a time when the team is already stretched, having completed the main part of the trial and staff have moved on, while those remaining on the team are focused on the endpoints. Many clients are now therefore choosing to outsource this activity. High quality narratives allow the agencies to quickly access the data they need to understand the clinical trial journey for any patient of interest as they review the completed study report (CSR). It is important to select the right service provider. Pharmora has a great deal of expertise to support the generation of high-quality narratives in fluent English that position the events and any alternative potential explanations in context so that an accurate assessment can be made.

Consideration of the benefits and risks starts long before any humans are exposed to an investigational product and continues throughout the life cycle. Pharmora can support your teams to develop a benefit-risk evaluation and help you to plan the early clinical studies accordingly.

When the results of new trials are available they need to be added to the Investigator Brochure (IB). The data need to be presented in a succinct but comprehensive way that is helpful to the Investigators involved with clinical trials for the product. Pharmora can support in summarising the data to present in the main body of the document, and can support with updating the section “Guidance for the Investigator” where appropriate, based on these new findings.

As part of our clinical monitoring service, we can offer MedDRA coding support. Our scientists can also review coding that has been manually performed or autocoded, and provide feedback to the Coding team. The Chief Medical Officer runs training for our scientists on MedDRA and how to review coding. Contact us to find out more about how we can support you.

At any time during the product life cycle safety signals will be detected. These could be generated on a routine basis by the Patient Safety team or received as an alert by a regulator. Pharmora can support with the evaluation of these signals and can provide input into any regulatory interactions required to defend or amend the product label.

Pharmora can provide bespoke training in safety or clinical development for any stage in the product life cycle. This includes web-based or face to face training with a trainer experienced in the relevant subject matter, or developing resources for your teams to facilitate standardised high quality deliverables. Contact us to find out how we can support you.

Pharmora employees have succeeded through our stringent set of selection and interview processes. This ensures our safety scientists and medical teams are of the highest quality. They are then trained and supervised by the Chief Medical Officer, who is a highly experienced pharmaceutical physician. We therefore provide an assured outsourced service, whereby any members of our team who work for you will continue to have the full support of Pharmora. This service is assured regardless of whether you need a specific deliverable from a Pharmora team or support by a nominated individual who will embed smoothly into your team for the duration of the project.

All products on the market in the EU, UK and many other regions must have a risk management plan (RMP) and this is therefore a mandatory requirement in the submission of a marketing authorisation application. However, most companies begin drafting the RMP early in clinical development so that it is available for use when planning trials and can be refined so that it is perfect by the time of submission. Pharmora can support with RMP production at any stage in the product life cycle.

The results of a clinical trial are only as good as the data that they are based on. High quality data means a more reliable result and reduces the risk of regulatory queries and delays during review of marketing authorisation applications. Pharmora can review the data to identify potential errors, raise queries and ensure they are addressed before closure. We can provide a team approach to reviewing data outputs from your clinical trial database, or we can provide nominated individuals who embed within your team to facilitate site interactions and address data queries directly.

At the end of every trial the regulatory agencies require a set of narratives for every serious or medically relevant adverse event. These come at a time when the team is already stretched, having completed the main part of the trial and staff have moved on, while those remaining on the team are focused on the endpoints. Many clients are now therefore choosing to outsource this activity. High quality narratives allow the agencies to quickly access the data they need to understand the clinical trial journey for any patient of interest as they review the completed study report (CSR). It is important to select the right service provider. Pharmora has a great deal of expertise to support the generation of high-quality narratives in fluent English that position the events and any alternative potential explanations in context so that an accurate assessment can be made.

Consideration of the benefits and risks starts long before any humans are exposed to an investigational product and continues throughout the life cycle. Pharmora can support your teams to develop a benefit-risk evaluation and help you to plan the early clinical studies accordingly.

When the results of new trials are available they need to be added to the Investigator Brochure (IB). The data need to be presented in a succinct but comprehensive way that is helpful to the Investigators involved with clinical trials for the product. Pharmora can support in summarising the data to present in the main body of the document, and can support with updating the section “Guidance for the Investigator” where appropriate, based on these new findings.

As part of our clinical monitoring service, we can offer MedDRA coding support. Our scientists can also review coding that has been manually performed or autocoded, and provide feedback to the Coding team. The Chief Medical Officer runs training for our scientists on MedDRA and how to review coding. Contact us to find out more about how we can support you.

At any time during the product life cycle safety signals will be detected. These could be generated on a routine basis by the Patient Safety team or received as an alert by a regulator. Pharmora can support with the evaluation of these signals and can provide input into any regulatory interactions required to defend or amend the product label.

Pharmora can provide bespoke training in safety or clinical development for any stage in the product life cycle. This includes web-based or face to face training with a trainer experienced in the relevant subject matter, or developing resources for your teams to facilitate standardised high quality deliverables. Contact us to find out how we can support you.

When submitting a New Drug Application (NDA) or Marketing Authorisation Application (MAA) the entire dossier of the product needs to be collated. This includes all the study reports plus the Clinical Summary of Safety (CSS) and Clinical Summary of Efficacy (CSE) and the Clinical Overview. Pharmora can support with all clinical documents and with the associated presentations to regulatory agencies in face-to-face or online interactions.

During a dossier review process the regulatory agencies will submit questions to the Applicant. Pharmora can help to review the data to support these responses, and support with drafting the responses including collating input from multi-disciplinary contributors within our clients’ teams.

Before regulatory agencies approve a product for marketed use, they will perform inspections. Pharmora can support your teams to prepare for this in a number of ways: we can audit your SOPs and other procedural documentation to identify gaps; we can train members of your team to prepare them for the inspection; we could help you develop an “inspection-readiness plan” and we can support to update any documents as required following the inspection, such as CAPA plan and new or updated SOPs.

All products on the market in the EU, UK and many other regions must have a risk management plan (RMP) and this is therefore a mandatory requirement in the submission of a marketing authorisation application. Pharmora can support with RMP production at any stage in the product life cycle. If there is no RMP already in existence Pharmora can help determine whether a Risk Evaluation and Mitigation Strategies (REMS) document is required in the US and draft an RMP for rest of the world based on data in the submission dossier. If an RMP has already been created for the product during clinical development Pharmora can review this and determine whether updates would be required to support marketed use.

Once a product is approved for marketing by a country’s regulatory agency it can be sold for specific uses in that country. However in order for it to be used widely by a national healthcare system it must also be reviewed by a reimbursement agency. These groups assess the product in the current landscape of other available healthcare resources and determine whether or not to reimburse its use. This assessment makes a massive impact to the manufacturer as it means the difference between small amounts of sales to private medical companies or individuals compared with the large-scale sale to an entire healthcare system, making the product available to anyone in that country. Reimbursement agencies require a specific package of data to be reviewed by specialists in healthcare economics and medicine. Pharmora can perform literature reviews to support this package and can medically review this package to help refine the key messages, providing the most appropriate presentations of data.

When submitting a New Drug Application (NDA) or Marketing Authorisation Application (MAA) the entire dossier of the product needs to be collated. This includes all the study reports plus the Clinical Summary of Safety (CSS) and Clinical Summary of Efficacy (CSE) and the Clinical Overview. Pharmora can support with all clinical documents and with the associated presentations to regulatory agencies in face-to-face or online interactions.

During a dossier review process the regulatory agencies will submit questions to the Applicant. Pharmora can help to review the data to support these responses, and support with drafting the responses including collating input from multi-disciplinary contributors within our clients’ teams.

Before regulatory agencies approve a product for marketed use, they will perform inspections. Pharmora can support your teams to prepare for this in a number of ways: we can audit your SOPs and other procedural documentation to identify gaps; we can train members of your team to prepare them for the inspection; we could help you develop an “inspection-readiness plan” and we can support to update any documents as required following the inspection, such as CAPA plan and new or updated SOPs.

All products on the market in the EU, UK and many other regions must have a risk management plan (RMP) and this is therefore a mandatory requirement in the submission of a marketing authorisation application. Pharmora can support with RMP production at any stage in the product life cycle. If there is no RMP already in existence Pharmora can help determine whether a Risk Evaluation and Mitigation Strategies (REMS) document is required in the US and draft an RMP for rest of the world based on data in the submission dossier. If an RMP has already been created for the product during clinical development Pharmora can review this and determine whether updates would be required to support marketed use.

Once a product is approved for marketing by a country’s regulatory agency it can be sold for specific uses in that country. However in order for it to be used widely by a national healthcare system it must also be reviewed by a reimbursement agency. These groups assess the product in the current landscape of other available healthcare resources and determine whether or not to reimburse its use. This assessment makes a massive impact to the manufacturer as it means the difference between small amounts of sales to private medical companies or individuals compared with the large-scale sale to an entire healthcare system, making the product available to anyone in that country. Reimbursement agencies require a specific package of data to be reviewed by specialists in healthcare economics and medicine. Pharmora can perform literature reviews to support this package and can medically review this package to help refine the key messages, providing the most appropriate presentations of data.

Following marketing authorisation approval, a Periodic Benefit Risk Evaluation Report (PBRER: the replacement for PSUR) is required at specific intervals in the EU and UK, and is expected in many other regions globally. Pharmora can support in creating these reports; conducting signal evaluations to present in the PBRER and collate contributions from multiple teams to complete the document.

At any time during the product life cycle safety signals will be detected. These could be generated on a routine basis by the Patient Safety team or received as an alert by a regulator. Pharmora can support with routine safety surveillance to identify such signals and fulfil regulatory requirements. This includes conducting comprehensive literature searches and reviewing data such as the client’s clinical trial data. Pharmora can work with signal generation outputs such as EB05 to support with the evaluation of these signals and can provide input into any regulatory interactions required to defend or amend the product label.

When investigating new indications or potential markets it may be necessary to work with a partner organisation. Ensuring the robust transfer of safety data and appropriate division of safety responsibilities between all parties is critical in maintaining the existing product licences. Pharmora can support the production and finalisation of a safety data exchange agreement to comprehensively document the necessary activities relating to patient safety.

Following marketing authorisation approval, a Periodic Benefit Risk Evaluation Report (PBRER: the replacement for PSUR) is required at specific intervals in the EU and UK, and is expected in many other regions globally. Pharmora can support in creating these reports; conducting signal evaluations to present in the PBRER and collate contributions from multiple teams to complete the document.

At any time during the product life cycle safety signals will be detected. These could be generated on a routine basis by the Patient Safety team or received as an alert by a regulator. Pharmora can support with routine safety surveillance to identify such signals and fulfil regulatory requirements. This includes conducting comprehensive literature searches and reviewing data such as the client’s clinical trial data. Pharmora can work with signal generation outputs such as EB05 to support with the evaluation of these signals and can provide input into any regulatory interactions required to defend or amend the product label.

When investigating new indications or potential markets it may be necessary to work with a partner organisation. Ensuring the robust transfer of safety data and appropriate division of safety responsibilities between all parties is critical in maintaining the existing product licences. Pharmora can support the production and finalisation of a safety data exchange agreement to comprehensively document the necessary activities relating to patient safety.