Large Pharma

Raising queries efficiently from the beginning of the trial helps the sites to learn how the data should be entered and minimises the number of queries at the end.

Pharmora can review data either in outputs such as spreadsheets or directly in the electronic data capture system (EDC) and generate queries to resolve inconsistencies. We can also manage those queries and ensure the data are accurate before they are closed.

We can work with blinded data or, due to our expertise in pharmacovigilance, we can also work with unblinded data while keeping the study team blinded.

Read this case study on unblinded medical review.

By utilising our highly trained in-house team we can keep costs down while maintaining high quality. Read more here.

We can help to review and analyse the data from clinical trials to develop key messages for successful submission documentation. This includes analysis of the safety data, providing relevant company clinical comments to explain any alternative potential causal factors and put the events into context.

During review by the agencies Pharmora can support in crafting robust responses to regulatory questions, develop slides to present at meetings and represent the company where needed, to defend the proposed indication.

Our highly trained medical scientists and medics can step in to support your global medical team whenever you have a gap. This could be due to planned absences such as maternity/paternity cover, unplanned absences such as long term illness, or due to peaks of workload.

Pharmora works on an assured model as an outsourced service provider. The advantage of this is that we have a team approach, with experienced, highly skilled scientists and medics supporting those with less experience, to maintain the consistent, high quality service our clients expect.

We normally assign 3 scientists to each FTE for a specific project, with one being the Nominated Lead Individual. The Lead will be the key point of contact with the client, is available for meetings and will coordinate all activities. The other scientists act as a back up for times when the Lead is out of office or has other commitments, such as administrative time or participating in continuing professional development (CPD).

The back up scientists will be trained on the study by shadowing the Lead (at Pharmora expense) and helping out with the fluctuating workload, which means they are fully up to speed in the background and able to hit the ground running at those times when they are needed.

This flexible team approach is ideally suited for the clinical development space, where there are peaks and troughs of workload every week. It means we can allocate more than 1 FTE for times of peak workload, deliver the right number of hours of work overall, and focus on the deliverables, to meet our clients’ needs.

… including ongoing surveillance and review of potential signals, or can review a package of signals, for example at the end of the study when analysing the safety data, or when taking over a product from a different manufacturer and applying new signal criteria.

Read our case studies to see examples of how Pharmora has added value with signal evaluations.