The Dynamics

the Dynamics of Clinical Data Management

SPC

StokmanPharmaConsulting

StokmanPharmaConsulting. Outside support with inside knowledge.

 

Clinical Data Management evolved tremendously over the last decade, and we are not done yet.

 

Revolutions in web-based technologies allowed CDM to facilitate study approaches that were never possible before, dealing with bigger studies, new biomarkers, adaptive designs, innovative patient-reported outcomes, and stakeholders all over the globe.

 

This arguably turned Clinical Data Operation into one of the most dynamic areas in the clinical development arena. In addition to keeping abreast with new technologies, compliance, quality, and efficiency are preeminent requisites in our business.

 

Initiatives driven by Regulators and by our own organizations necessitate us to keep on improving. Currently eSource, Risk-Based Quality Management, Strategic Partnerships, Risk-Based Monitoring, Central Data Review and Operational excellence are among the themes we should be working on, just to remain in place.

 

If we want to get ahead of the curve, in addition, we need to dedicate time to do some strategizing: get closer to the science, understand what’s coming up in the field of biomarkers, eCOA, eHealth, post-approval commitments… So many initiatives!

 

Day-to-day business - with all its small and big issues - makes it challenging to pay sufficient attention to the multitude of initiatives to make sure nothing slips between the cracks.

 

To bring a Vision to Fruition, you need structure, collaboration & disciplined execution.

 

StokmanPharmaConsulting offers unique temporary in-house Clinical Data Operations Expert support for new initiatives, or ongoing projects that need more dedicated support than the organization can muster.

 

StokmanPharmaConsulting. Outside Support with Inside Knowledge

 

- bringing groups together,

- identifying the necessary pieces of the puzzle,

- creating structure and planning

 

allowing for expeditious implementation; efficient & in compliance.

Please reach out for information on options & availability:

Peter G. Stokman, MSc

Oss, the Netherlands

+31 (0)6 1909 3992

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