staff augmentation model in action -...

Staff Augmentation Model in Action

Clinical Data Management • Programming • Biostatistics • Medical Writing • Pharmacovigilance

IntroductionI recently completed a 3 month placement providing programming support for a large pharmaceutical company. This was our first collaboration with the company so it was imperative that we were able to show them our capabilities. In addition to myself, a number of other Quanticate programmers were requested to temporarily relocate to work onsite at the company’s European headquarters. This enabled us to integrate with the existing programming team and strengthen the flow of communications. We were then able to gain an understanding of the work required and familiarise ourselves with the company systems quickly.

Work InvolvedDuring my time working with the client I personally provided programming support on two separate ISS submissions. The first was complex in nature as it involved the integration of a number of connected smaller studies, mapping the SDTM data to produce one set of CDISC compliant ADaM datasets for each domain. Having spent a considerable amount of time working to CDISC compliance in the past for both SDTM and ADaM specifications and having been familiar with the standards, this process was straightforward. Using this vast experience we knew where to look for any potential issues so that these could be highlighted to the rest of the team and avoided. The main task for me was to validate the ADaM data, ensuring that there was consistency across the studies so that they could be integrated seamlessly.

Client SystemsAt Quanticate we have worked for many clients using their systems to produce the required outputs for a number of years. So once the required access was granted and a brief induction was provided, I was able to navigate the company’s in-house system straight away. After creating the relevant folders and directories, I quickly learnt how each of the macros worked from the company suite and was producing outputs almost instantly.

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Staff Augmentation Model in Action Working InvolvedThe second submission again required the validation of CDISC compliant ADaM data from a number of separate studies, however this time from sources other than SDTM. To start with, we were given a set of specifications from which to create the datasets. In order to maintain CDISC compliance we highlighted any issues found within the specifications to the team and, once updated, we began producing programs which standardised each of the studies data and then combined into one dataset per domain. Once the data was validated, I was then able to move onto the validation of the outputs. With Quanticate’s extensive experience of both producing and validating tables, listings and figures to a high quality, we were able to complete the validation process relatively quickly.

OutcomesWith the programming knowledge and support provided by myself and others at Quanticate, all tasks were completed efficiently and successfully without issue and to a high standard of quality, enabling the submission go ahead as planned without delay. The promptness of the completion of this programming support was crucial in the reduction of the time taken to submit reports to the FDA for approval. If this were to continue, this would provide further efficiency in the drug development process and could potentially decrease the time taken to bring new treatments onto the market. This would ultimately lead to an improvement in patient healthcare.

Future Based this on initial success a good relationship has been built with this client and an increased programming pool has been implemented to ensure we are enable to meet the demands of the work. With Quanticate’s future involvement, we will continue to provide a pool of experienced programmers which will in turn ensure an increased turnaround of work.


staff augmentation model in action -...

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