The problem
Database lock slips because of decisions made at CRF design.
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.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
The full lifecycle.
CRF design
Forms designed for the analysis they will feed, not just the protocol text.
Database build
Build and UAT with the edit checks specified before the first patient.
Edit checks
Enough to catch real errors, few enough that sites do not learn to ignore them.
Medical coding
MedDRA and WHODrug coding with a documented convention.
Reconciliation
SAE, external vendor and lab data reconciled continuously rather than at the end.
Database lock
A planned event with a checklist, not a scramble.
For consultants
Roles we place in data management.
CDM and programming roles are frequently remote, which makes them some of the most competitive work we handle.
- Clinical Data Managers, all levels
- Clinical Database Programmers
- EDC Build Specialists (Rave and others)
- Medical Coders
- Data Standards and CDISC Specialists
- Data Management Leads
Proof
Design
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
Questions we get asked.
Which EDC platforms do you work with?
Established platforms including Medidata Rave, plus partner technologies. We can work in your instance or provide one.
Can you take over a build someone else started?
Yes, beginning with a review of the specification and what has actually been implemented, which are not always the same.
Do you handle CDISC deliverables?
Yes, SDTM and ADaM datasets and the associated documentation, usually alongside the statistics team.
Is this work remote?
Mostly, which is why these roles attract strong candidates and move quickly.
How do you price a database build?
Usually fixed scope, since the deliverable is definable. Ongoing data management is time and materials.
Related
Where to go next.
Talk to someone who has done this.
Hiring for it, or looking for the work. Either conversation is welcome.