Delivering Medical Scientist Services

Written by Tom Botham

Tom’s story of embedding within a client team:

In one role a client was in urgent need of a medical scientist to join the team and aid in an important date base lock.  The data base lock was significant as it was the final analysis of data relating to their primary end point of overall survival, prior to moving onto their secondary endpoint of progression free survival.  The importance of data integrity at such a time was immense.  The consistent revision and updating of background, clinical-trial specific training and study generic knowledge that is provided by Pharmora’s chief medical officer (CMO) and external training programs, makes acclimation periods and onboarding into new studies extremely simple.  Pharmora’s CMO has placed huge importance on the revision of RECIST guidelines, good clinical practice (GCP) and adherence to SOP’s.  This constant revision keeps me at the forefront of what is required for high end contributions to client study teams.  This was no different with the client in question. 

It was a simple case of discussing with the client the expectations and level of involvement that would be needed from my time on the study.  Study specific training was provided in a running-start style of involvement.  The client was keen on the completion of trainings with electronic data capture services, centralised monitoring systems and clinical trial review systems; all of which got completed without hinderance.  Pharmora’s ethos with regards to client contributions is one of trust and continued development.  My initial contributions towards the client were reviewed by the CMO to check that the work was of the required quality.  This process sets the bar: the CMO’s review and advice allows for a template of quality to be adhered to.  Once the CMO had reviewed the work and set the standard, further work was not run by the CMO, but the standard was expected to be met 100% of the time.  This expectation was met and I received excellent feedback from the client.  The CMO is always available for up-skilling processes.  This makes sure that as a member of a client team, I never remove resource or time I only contribute.

I believe that by nature, clients may be sceptical of new members joining their team, especially when tensions are heightened by important situations such as that described here.  As the faith the client had in me continued to grow and the relationship between myself and the team members strengthened, my level of involvement and the importance of the work given to me also grew.  Their trust in me to produce valid, high-quality pieces of work led to key involvements in blinded data reviews, data deep dives, study level safety reports, translational research, discrepancy threshold reviews, high level result analysis, global physician reports, medical answered query reports, protocol deviation assessments and assessments of study specific serious adverse events. My affiliation with projects within the team also led to direct working communication with the Pharmaceuticals Medical Devices Agency (PMDA) and the Food and Drug Administration (FDA).  To be more specific, my involvement with PMDA, a notoriously strict regulatory body, led to the approval of the client’s product for use in Japan.

 

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