Clinical data management, audit-ready by design.
Praveg provides clinical data management consulting and operations support for sponsors, CROs and clinical technology companies: from eCRF design and edit-check programming through cleaning, coding, reconciliation and database lock. It is for organisations that need CDM delivered to GCDMP and ICH GCP standards without building the whole function in-house.
Scope of work
Study start-up
Protocol review, eCRF design, metadata build and edit-check programming.
- CRF and database specification
- Edit-check specification and UAT
- Data Management Plan
Data collection and cleaning
EDC configuration, site training, query management and discrepancy resolution.
- Query strategy and metrics
- Medical coding (MedDRA, WHODrug)
- SAE and external data reconciliation
Database lock
Lock checklist, QC, audit trail review and final reconciliation.
- Blind review preparation
- Lock readiness assessment
- Archival and TMF completeness
CDM function setup
SOPs, QMS, role structures and operating model for a new or growing data management function.
- System-agnostic SOP suite from eCRF design to archival
- Role definitions and training matrix
- Capacity and vendor model
A good fit when
- Sponsors and CROs scaling their data management capacity
- Clinical technology companies that need CDM process depth
- Organisations preparing a function for its first audit
Senior, hands-on, accountable
Discovery call
A conversation about the real problem, not only the stated one.
Scoped proposal
Fixed scope, retainer or fractional model, with outcomes named.
Delivery alongside your team
Implementation, not only recommendations; adoption measured.
Handover and sustain
Capability transferred, lighter-touch support thereafter.
Trusted across industries
Praveg provided valuable strategic direction while helping us establish scalable biometrics processes. Their understanding of both operations and technology ecosystems significantly accelerated our setup activities.
The guidance on EDC workflows, role structures, and governance models helped us avoid several costly mistakes during our platform planning phase.
The training sessions bridged the gap between textbook knowledge and industry realities. Participants particularly appreciated the practical examples from live clinical-trial environments.
The Clinical Data Management course content was industry-oriented and extremely relevant for freshers entering the field.
FAQ
Which EDC platforms do you support?
Praveg works across the major EDC platforms and designs system-agnostic processes, so SOPs and specifications transfer between systems.
Can you set up a CDM function from scratch?
Yes. Praveg has set up data management functions for CROs and clinical technology companies: SOPs, QMS, roles, training and the operating model, with the first studies run alongside the team.
Let’s accelerate together.
Reach out for a discovery conversation, no obligation, just clarity on where structure can unlock speed.