Clinical development.
Pharmora has scientists and physicians experienced in all phases of the product life cycle across many therapeutic areas. Pharmora can provide medical and scientific expertise to support key areas of global clinical research including defined deliverables, flexible resources and training of internal client personnel, to help you prepare for milestones from study start-up to submission.
We have built a strong reputation by delivering high quality services in order to support our clients to achieve their goals.
Pharmora has specific expertise in supporting clinical development and submission activities including preparation for key study milestones or governance interactions during clinical development, submission and inspection-readiness activities towards the end of pivotal clinical studies and support for regulatory interactions during the review period and beyond. Please feel free to reach out to us to find out how we could support your projects.
Pharmora medics and scientists are trained to support your study teams in global clinical development activities. Our services range from delivering packages of work, such as data cleaning ahead of interim or final analysis, to providing nominated individuals who can work alongside your team to support delivery of complex clinical trials.
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:
Case Studies
Click below to read some case studies written by our team:
Challenge: Safety Narratives
At the end of every study the completed study report (CSR) is required. A mandatory part of the CSR is a narrative for every patient that fulfils specific categories associated with safety. These CSR narratives need to be generated on the validated final analysis dataset. This is when the statisticians and programmers are busy generating the final outputs and the medical team are busy finalising key messages, which means safety narratives coincide with the busiest time for the study team, and there are usually hundreds of them. Any delays to the safety narratives could mean delays to submission of the CSR so there is always a great deal of pressure to deliver these within tight deadlines.
Pharmora solutions
Pharmora can be involved at any stage of narrative development, from the design of tables and the generation of a template for the written part, to writing the narratives or reviewing and updating those written by other service providers or automated programmes. The regulatory agencies mandate these narratives as part of a dossier submission when applying for marketing authorisation (MAA) or a new drug application (NDA). Poor quality narratives can reflect badly on the entire submission, therefore Pharmora ensures the written part is a clear description of what happened to the patient during the trial to facilitate regulatory assessment.
Challenge: Safety Narratives
At the end of every study the completed study report (CSR) is required. A mandatory part of the CSR is a narrative for every patient that fulfils specific categories associated with safety. These CSR narratives need to be generated on the validated final analysis dataset. This is when the statisticians and programmers are busy generating the final outputs and the medical team are busy finalising key messages, which means safety narratives coincide with the busiest time for the study team, and there are usually hundreds of them. Any delays to the safety narratives could mean delays to submission of the CSR so there is always a great deal of pressure to deliver these within tight deadlines.
Pharmora solutions
Pharmora can be involved at any stage of narrative development, from the design of tables and the generation of a template for the written part, to writing the narratives or reviewing and updating those written by other service providers or automated programmes. The regulatory agencies mandate these narratives as part of a dossier submission when applying for marketing authorisation (MAA) or a new drug application (NDA). Poor quality narratives can reflect badly on the entire submission, therefore Pharmora ensures the written part is a clear description of what happened to the patient during the trial to facilitate regulatory assessment.
Challenge: Flexible medical 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: Flexible medical 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.
Case studies
Click below to read some case studies written by our team:
Case Studies – Unexpected Signal Evaluations
Pharmora helped to meet a tight deadline for submitting an application for marketing approval by reviewing multiple signals to support the safety profile.
Case Studies – How Safety Saved a Study
Pharmora safety monitors conducted a signal evaluation that saved a clinical trial from disaster. Read on to find out how!
Case Studies – Providing an Entire Safety Department
Pharmora provided an entire safety department to set up safety processes and monitoring over a 6-year period leading to successful global product approvals.
CSR Safety Narratives – Part 2 of 2 (Saving your time and money)
Pharmora has demonstrated the ability to deliver high quality, medically-reviewed safety narratives to append to the completed study report (CSR) for our clients. Read the second part of this case study to find out how we do it so well…
CSR Safety Narratives – Part 1 of 2 (Saving your time and money)
Pharmora has demonstrated the ability to deliver high quality safety narratives to append to the completed study report (CSR) for our clients. Read the first part of this case study to find out how we can save you time and money…
Case studies – Data Quality Management
The team at Pharmora helped a clinical development team prepare for a critical interim analysis.
How can Pharmora help to commercialise your product? (Part 2)
Pharmora can help bring more medicines to the patients who benefit from them, helping the patient and the manufacturer. Read more to find out how!
In this second blog of two the CMO describes how Pharmora can increase the chances of success for a new product to secure its place in the global medicines market.
How can Pharmora help to commercialise your product? (Part 1)
Pharmora can help bring more medicines to the patients who benefit from them, helping the patient and the manufacturer. Read more to find out how!
In this first blog of two the CMO describes the context of our work
