GEM Programming Solutions

Insourcing

Insourcing

GEM Programming can partner with your organisation to help you manage your workload peaks as effectively as possible, with minimal start up time.

As a sponsor, reporting your key studies in house, using your own internal SOP framework and SAS® reporting platform has its obvious advantages. However, managing internal resources effectively in a biometrics team can be a difficult balancing act.

A clinical development plan with many moving parts can mean that you need to urgently identify programming resources to supplement your existing team. GEM Programming can partner with your organisation to help you manage your workload peaks as effectively as possible. We can provide you with SAS® Programmers with exactly the right skillset to cover short term gaps in your resource needs.

We have experienced programmers with 20+ years who have the technical skills, management skills and proven industry experience to lead the delivery of your study or submission package.

We also have highly skilled SAS® certified Programmers who can complement your existing programming team to provide additional resources during those busy periods with minimal start-up times.

By partnering with GEM and flexibly using our resources to your advantage, you can report your study in house, using your in-house reporting platform and your own SOP framework.

Other Services

Functional Service Provision

GEM can report your clinical studies (Phase I to IV), complying with CDISC standards as appropriate. We can also support delivery of SRM/DSMBs, investigator brochure materials, post-hoc analyses or pooled data creation.
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Expert Programming Consultancy

GEM can provide strategic guidance for submission preparation to key agencies including FDA, EMA, PMDA. We can also support responses to regulatory agencies, both written questions and formal meetings such as advisory committee meetings.
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Contact us today to find out more about GEM Insourcing opportunities.