The problem
A form that captures a field ambiguously produces queries for the life of the study. A missing edit check produces a reconciliation problem eighteen months later. Almost every painful lock traces back to a design decision made quickly at the start, when nobody had time.
The second cause is fragmentation. Data management sits with one vendor, statistics with another, and the specification each is working to diverges quietly until someone runs the first real analysis.
We would rather spend an extra week on design than a month on cleaning, and we keep data management and statistics close enough to notice when a specification drifts.
Tell us the problem. A specialist replies, not a form robot.
What we do
Forms designed for the analysis they will feed, not just the protocol text.
Build and UAT with the edit checks specified before the first patient.
Enough to catch real errors, few enough that sites do not learn to ignore them.
MedDRA and WHODrug coding with a documented convention.
SAE, external vendor and lab data reconciled continuously rather than at the end.
A planned event with a checklist, not a scramble.
For consultants
CDM and programming roles are frequently remote, which makes them some of the most competitive work we handle.
Proof
Where most lock problems are actually created.
Client testimonials for this discipline are being collected and will appear here once approved in writing by the clients concerned.
Questions
Established platforms including Medidata Rave, plus partner technologies. We can work in your instance or provide one.
Yes, beginning with a review of the specification and what has actually been implemented, which are not always the same.
Yes, SDTM and ADaM datasets and the associated documentation, usually alongside the statistics team.
Mostly, which is why these roles attract strong candidates and move quickly.
Usually fixed scope, since the deliverable is definable. Ongoing data management is time and materials.
Related
Hiring for it, or looking for the work. Either conversation is welcome.