Clinical research consultants and clinical operations support
Clinical operations, study start-up and delivery support for sponsors and CROs, from protocol to clinical study report.
The problem we solve
Studies slip on people, not on science.
Start-up stalls waiting for a CTA to be drafted. Monitoring visits fall behind because a CRA resigned mid-study. Data cleaning takes three months because the CDM team was sized for a smaller trial. None of these are scientific problems; all of them cost weeks.
Vakula provides experienced clinical professionals who can step into a running study, and managed teams for defined packages such as start-up, monitoring or database lock.
Tell us what you need
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What we do
Clinical Research capabilities
Clinical operations
Study managers, CTAs and clinical operations leads for sponsor and CRO teams.
Study start-up
Site feasibility, selection and qualification, IRB/EC submissions and essential document collection.
Clinical monitoring
On-site, remote and risk-based monitoring by experienced CRAs. See Trial Monitoring for the full service.
Clinical data management
CRF design, EDC build, data cleaning, SAE reconciliation and database lock.
Medical writing
Protocols, investigator brochures, clinical study reports and patient-facing documents.
Vendor and site oversight
Central lab, IRT and supply chain vendor management, site performance tracking.
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
Do you run trials as a CRO?
We deliver defined packages of clinical work, such as monitoring or data management, under a statement of work. For a full-service CRO engagement we partner with a CRO and supply the people and oversight.
Which therapeutic areas?
Our consultants have worked across oncology, CNS, cardiovascular, metabolic, infectious disease and rare disease programmes. We match on therapeutic experience when it matters to the role.
Which EDC systems?
Medidata Rave, Veeva Vault CDMS, Oracle InForm and Castor are the most common among our consultants.
Can you backfill a CRA quickly?
Often within days for US-based roles, because we maintain relationships with CRAs between assignments. We confirm availability before we present anyone.
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.