01 · Start-up
Translate the protocol into a workable data foundation.
Align the data management plan, CRF and database design, build activities, and edit-check specifications with the study requirements.
Clinical biometrics service
Clinical data management services for reliable study delivery.
Plan, build, clean, reconcile, and lock clinical trial data with clear ownership from study start-up through closeout.
Keep study data ready for the decisions ahead.
Clinical data management connects protocol intent, database design, day-to-day review, and the final handoff for analysis. Gurus shapes the work around your protocol, systems, timelines, and operating model, with responsibilities and review points defined at the outset.
Core capabilities
- Data management plans and supporting documentation
- CRF design, database design, and build
- Edit-check specifications, data validation, and query support
- External data transfer and reconciliation
- Medical coding with MedDRA and WHODrug Global
- Database lock, archiving, and eTMF filing support
Study lifecycle
Support across the clinical data lifecycle.
02 · Study conduct
Make data review and reconciliation visible.
Support validation, queries, external data transfers, reconciliation, and medical coding throughout active study delivery.
03 · Lock and closeout
Coordinate a controlled path to final data.
Bring outstanding review activities together for database lock, archiving, documentation, and downstream handoffs.
How Gurus fits
A defined role within your existing study team.
Gurus can take ownership of a focused data-management workstream or contribute within a wider sponsor or CRO model. Scope, systems, interfaces, review points, and handoffs are agreed around the people and processes already in place.
Connected where it helps.
Keep clinical data management focused, or connect it with downstream programming, statistics, and submission support.
Common questions
Clinical data management FAQs.
Clear answers before we define the study-specific scope.
Which stages of clinical data management can Gurus support?
Support can be scoped from study start-up and database design through ongoing data review, reconciliation, medical coding, database lock, archive, and documentation. The exact responsibilities are agreed for each study.
Can Gurus work within our existing clinical data systems?
The delivery model is shaped around the systems and processes your team already uses. System access, compatibility, responsibilities, and required interfaces are confirmed during scoping.
Do you support external data reconciliation and medical coding?
Yes. Gurus can support external data transfer and reconciliation, together with medical coding using MedDRA and WHODrug Global, when included in the agreed scope.
Can clinical data management be combined with programming or biostatistics?
Yes. Clinical data management can be engaged as a focused service or connected with SAS programming, R programming, biostatistics, and CDISC submission support through one coordinated model.
Your study, your operating model
Define the right clinical data management scope.
Tell us what is already in place and where your study needs added ownership or specialist capacity.