GEM Programming Solutions

Case Studies

Case Study 1

One of our clients asked GEM if we could take over the reporting of a phase II oncology study. Another company had made a start on the programming of the SDTM and ADaM datasets but were unable to continue to complete the reporting.

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Case Study 2

Having been recommended by a statistician colleague, a Biotech organisation approached GEM with an interesting request to harmonise safety data from several legacy phase I studies.

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Case Study 3

One of our senior GEM consultants is providing expert programming advice to a European based biopharmaceutical organisation that is preparing its lead candidate drug for US and EU submissions in 2021.

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Case Study 4

One of our clients asked GEM if we could convert a legacy phase II study (that had reported ~ 10 years previously) into CDISC SDTM and ADaM compliant standards so that the supportive data from this study could be included in a New Drug Application.

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Case Study 5

A UK based Biotech company was looking to urgently bolster their internal biometrics resources on a short-term basis with several contract programmers. The resources were needed to report a phase I oncology study and deliver other ad-hoc reports as required.

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Case Study 6

Having worked at AstraZeneca for many years, both Mark and Paul have built up an extensive network of ex-colleagues with expertise in all aspects of Clinical Development, but specifically in the fields of Programming, Statistics, Medical Writing and Data Management.

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If you are looking for expert statistical programming with a friendly and flexible approach, contact us today to learn more about our services.