Clinical trial management services
Study planning, site and vendor management, quality oversight and data management, as full-service or stand-alone support.
The problem we solve
Every hand-off in a study is a place to lose time.
Site selection, IRB approval, supply release, data entry, query resolution, database lock: each is owned by a different function, and studies slip in the gaps between them.
Vakula trial management teams take defined pieces of that chain, or the whole of it, with one accountable study lead and reporting you can put in front of a steering committee.
Tell us what you need
A consultant replies, not an auto-responder. Typical response inside one business day.
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What we do
Trial Management capabilities
Clinical strategy and planning
Clinical development plans, protocol design input and study-specific training.
Site management
Site identification, feasibility, selection and qualification; IRB/EC submissions; subject recruitment support.
Vendor and supply management
Central lab, IRT and clinical supply coordination with documented oversight.
Risk-based monitoring
Key risk indicators, trend analysis and targeted monitoring. See Trial Monitoring.
Quality assurance
Study compliance checks, process verification, vendor oversight and regulatory services.
Data management
eCRF/pCRF design, EDC build, validation, discrepancy management, SAE reconciliation, database lock, CDISC conversion and archiving.
How an engagement runs
What happens after you contact us
Intake call
A consultant who works in this function takes the brief: scope, systems, regulatory context, timeline and budget band. Same day where possible.
Proposal and people
Within a few business days you get a written scope or a shortlist of named consultants with availability and rates. No generic CVs.
Kick-off under a clear SOW
Deliverables, acceptance criteria, reporting cadence and escalation path are agreed in writing before work starts.
Delivery with oversight
A Vakula engagement lead stays accountable for quality and continuity, including cover if a consultant rolls off.
Questions
Before the first call
Full service or stand-alone?
Either. Many clients start with one package, such as start-up or data management, and extend once the team has proven itself.
Who is accountable?
A named Vakula study lead, with an escalation path to an engagement director, written into the statement of work.
Which phases?
Phase I through IV and post-market studies, with most of our experience in Phase II and III.
Can you work inside our CTMS and EDC?
Yes. We work in client systems wherever possible so the sponsor retains the data and the audit trail.
Related
Adjacent services
Start with one requirement.
Send us a role, a scope or a problem. We come back with a plan and a named consultant, not a sales deck.