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Product development
Our client purchased a new unlicensed product which was the second in a new class to market and in a therapeutic area unfamiliar to them. JBM were briefed to produce a summary of the available evidence, using clinical trial reports and published clinical trials, to identify pertinent information for regulatory, medical and marketing departments.
Steps in the process carried out by JBM were as follows:
Step 1: Review all available evidence. The clinical trial reports ran to thousands of pages, therefore our ability to quickly identify and distil out relevant information was invaluable to the client.
Step 2: Produce individual data summaries for each trial using a standard template to enable the reader to quickly identify the study details, study population, efficacy variables and results. A conclusion provided a summary of the relevant finding of the study and study limitations provided an insight into areas where the study was inadequate. Take home points for each study identified the key outputs from the study.
Step 3: Produce an overall clinical data summary, pulling results of all relevant studies together in an easy to read document, relevant for regulatory, medical and marketing teams.
Outcomes: The materials are being used across the company to inform and educate staff around the new product and to inform product licensing and eventual marketing strategy.
