Advantra LifesciencesAdvantra Lifesciences

Clinical research support

Keep the study moving

We cover the roles a running trial cannot go without, for sponsors, CROs and research sites, placed against a live protocol.

Specialists

A monitor who has run your indication

We source against the protocol, so the CRA who arrives already knows the phase, the therapeutic area and the EDC your sites are running on.

Functional teams

Whole functions, run as a team

Data management, study start-up and safety delivered by a team on our payroll, priced by the month. You keep the science and the signature.

Workflow rebuild

AI that clears validation

We rebuild a clinical workflow around what an inspector can be shown, and staff the version that remains.

Trials stall in more than one place at once. A monitor leaves during enrollment, queries pile up ahead of lock, and the process was built for a smaller study. We work at all three levels.

Capabilities

Hire one, build a team, or rebuild the workflow

Three ways to buy the same bench.

Hire a specialist

One person inside your team, on your SOPs and your systems. We source against the protocol, so the CRA who arrives has run your indication at your phase.

Contract placements are on our W-2, with insurance, licensure and mid-study coverage carried by us.

ContractContract to hireDirect hireW-2 employment

Build a team

A full function delivered as a team, with hiring, retention and backfill carried by us. You keep the science and the sign-off.

Pods run from the United States or Hyderabad on our payroll, priced by the month against a defined scope.

Functional serviceMonthly pricingUS or HyderabadRetention on us

Rebuild a workflow

Validation is where AI pilots in clinical development usually stop. The output holds up and the evidence trail behind it does not.

We take one workflow, measure where the hours go, rebuild it around what can be evidenced, and staff the version that remains.

Two to four week mapGxP and CSVStaffed after rebuild
Where we get called in

The five calls we get most

Situations we get called into.

A CRA resigns at sixty percent enrollment

What we sendA monitor who has run the indication at that phase, with a handover window overlapping the outgoing CRA.

Start-up is slipping before first patient in

What we sendActivation specialists against the queue, or a pod once the site count justifies it.

Queries will not clear before lock

What we sendA data management pod on your EDC, sized to the open query volume.

A CRO win needs a team in six weeks

What we sendA functional team on your rate card, with employment and compliance carried by us.

An AI pilot cannot clear validation

What we sendA workflow map, a rebuild scoped around what can be evidenced, and the audit trail written during the build.
The trial lifecycle

Where we work

The roles change at every stage.

Study start-up

Feasibility, country and site selection, essential document collection

Site activation

Contracts and budgets, IRB and EC submissions, green light to enroll

Enrollment

Recruitment support, screen failure management, site engagement

Conduct and monitoring

On-site and remote monitoring, risk-based oversight, deviation management

Database lock

Query resolution, coding, reconciliation, lock and unblinding

Submission and beyond

Clinical study reports, dossier support, post-marketing safety

Systems we work in

Named on the requisition

Requisitions specify the platform, and we screen on it.

CTMS

Veeva Vault CTMS, Oracle Siebel CTMS, Medidata CTMS

EDC and clinical data

Medidata Rave, Oracle Clinical One, Veeva Vault EDC, Castor

eTMF

Veeva Vault eTMF, Phlexglobal, Montrium

IRT and RTSM

Signant Health, Suvoda, 4G Clinical

Safety databases

Oracle Argus Safety, ArisGlobal LifeSphere, Veeva Vault Safety

Programming and analytics

SAS, R, Python, CDISC SDTM and ADaM, define.xml

On Oracle

Oracle sits at the center of the parent firm. Clinical One, Siebel CTMS, Argus Safety and Oracle Health run alongside the EPM, ERP and OCI practice the rest of Advantra is built on, so an Oracle-shaped clinical requirement lands with people who already know the stack underneath it.

Platform names are stated to describe hands-on experience. No partnership, endorsement or affiliation is implied.

What is shaping clinical trials

What is squeezing trials right now

Decentralized and hybrid designs

The same teams are covering a wider surface than the protocol was resourced for.

What we do

Pods sized to the surface the study actually covers.

Start-up and activation lag

Contracts and essential documents sit in queues while the enrollment clock runs.

What we do

Specialists against the queue, or an activation pod once the site count justifies it.

AI that stalls at validation

Pilots produce good output and stop short of an inspector-ready audit trail.

What we do

We rebuild around what can be evidenced and write the documentation during the build.

The shift from hourly to functional

Sponsors are consolidating vendors and moving toward buying whole functions.

What we do

Monthly pricing with retention and backfill carried by us, under one contract.

Who we serve

Sponsors, CROs and research sites

Often more than one on the same trial.

Researcher analyzing samples in a laboratory

Sponsors

Large pharma through to a biotech with one asset in the clinic.

Chemist preparing a sample for analysis

CROs

Qualified people against a study already awarded, on your rate card.

Clinicians reviewing diagnostic results in a medical office

Sites and health systems

AMCs and site networks building research operations.

Laboratory bench during an experiment

Every study runs on people who have done it before. We find them, employ them, and keep them on the study until it locks.

Common questions

What sponsors and CROs ask first

Do you work directly with sponsors, or only through CROs?

Both, and often on the same trial. A sponsor may hold the specialist placements while the CRO runs the study, or the CRO may buy the whole function from us against a study they have been awarded.

Are contractors your employees or subcontractors?

Ours. Contract placements are Advantra W-2 employees, with insurance, licensure tracking, compliance and mid-study coverage carried by us. No pass-through vendor sits between you and the person doing the work.

Can you support GxP and computer system validation requirements?

Yes. Validation and audit documentation are part of delivery on both staffing engagements and workflow rebuilds, built to your quality system.

Where does the team sit?

The United States, or our Hyderabad site. Both are Advantra payroll and Advantra employment. Pods can run from either, or split across both where time zone coverage is part of the requirement.

What does a pod cost compared with hourly contractors?

Pods are priced by the month against a defined scope. Contractors are priced by the hour. Which one comes out lower depends on the function, the study size and the coverage model, and we will show you both.

How does a workflow engagement start?

With a map. Two to four weeks inside a single workflow measuring where hours are actually spent, then a scoped rebuild. If the measurement says the process is fine and you simply need people, we will tell you that.

Tell us what the study needs

Send the protocol summary, the gap, and the date it has to be covered by. We will come back with the roles, the rates and a start date.