HAROM India
HAROM MultiPV

One platform. Three ways to run pharmacovigilance.

Run your own PV on HAROM OnePV, run many clients behind one address, or take a dedicated instance — provisioned, governed and audited from one control office.

CRO model · Direct tenant · Single instance

HAROM MultiPV· Control office

HAROM control office

Every client in every model, the CROs and their people, and who changed what.

CROs

3

3 active

Clients

14

6 direct · 7 CRO · 1 single

CRO people

12

11 active

MultiPV users

4

4 active · 19 sign-ins this week

Clients by model

How each client runs

14CLIENTS
  • Direct6
  • CRO clients7
  • Single instance1

Changes over the last 30 days

8 this week · 23 in 30 days · every change by a Super Admin, with a reason

04830 days ago20 days10 daystoday

One control office

Every client, every model

Choose your model

The same platform. The operating model that fits you.

Every model runs the same HAROM OnePV applications with the same controls. What changes is who signs in where, and how your data is kept.

CRO model

For CROs and PV service providers

Your clients behind one address.

Your team signs in once and works across every client with the same role. Each client keeps its own segregated database, users and audit trail.

  • One sign-in for your whole team, Microsoft sign-in supported
  • Your logo on the sign-in page, HAROM as technology partner
  • A CRO dashboard across all clients, and one for each client
  • New clients provisioned by HAROM and open to your team at once
Direct tenant

For Mid-size pharma and MAHs

Your own address on HAROM's platform.

Your users, your data and every OnePV application, ready quickly and kept current by HAROM.

  • Own address and own database
  • Every HAROM OnePV application under one login
  • Upgrades applied by HAROM
  • Add markets and products without re-platforming
Single instance

For Top-tier pharma and groups

A dedicated environment, the same platform.

For organisations that require isolation: a dedicated server and databases, with the same applications and controls as every other model.

  • Dedicated server and databases
  • Same applications, same controls, same audit trail
  • Upgrades pushed by HAROM
  • Suited to enterprise security and data-residency requirements
The control office

Provisioned and governed from one place.

HAROM provisions every client, in every model, from one control office. Nothing changes without a Super Admin, a written reason and an audit entry.

  • Provision a client in any model

    Direct, CRO or single instance, from one place.

  • Review, then run set-up

    Nothing is created until a HAROM Super Admin has reviewed it.

  • CRO people and permissions

    Who works for which CRO, with which role, across which clients.

  • Who changed what

    Every change needs a written reason and is kept in an append-only record.

HAROM MultiPV· Control office

HAROM control office

Every client in every model, the CROs and their people, and who changed what.

CROs

3

3 active

Clients

14

6 direct · 7 CRO · 1 single

CRO people

12

11 active

MultiPV users

4

4 active · 19 sign-ins this week

Clients by model

How each client runs

14CLIENTS
  • Direct6
  • CRO clients7
  • Single instance1

Changes over the last 30 days

8 this week · 23 in 30 days · every change by a Super Admin, with a reason

04830 days ago20 days10 daystoday
The CRO dashboard

Every client, every deadline, one screen.

A CRO signs in once and sees the whole book of work: what is open, what is due, what went out on time and where an acknowledgement needs attention.

  • Every client at a glance

    Open, overdue, due today and due in seven days, across all clients or one.

  • Submission compliance

    Reports sent on time over the last 90 days, with late ones and acknowledgement problems called out.

  • Cases in, reports out

    Cases received against reports submitted, week by week.

  • One click to any client

    Switch client, keep your role, keep your context.

HAROM OnePV· CRO dashboard

Open cases

6

being processed now

Overdue

0

past the regulatory due date

Due today

1

in the client's time zone

Due in 7 days

4

plan the week

Submitted this month

18

reports sent

On time, 90 days

98%

41 on time · 1 late

ACK problems, 30 days

0

failed or rejected

Active users, 30 days

9

signed in

Submission compliance

Reports sent on or before their due date

98%ON TIME

41 on time · 1 late · 0 ACK problems

Cases received and reports submitted

Cases by clock start · reports by date sent · last 12 weeks

061212 wk8 wk4 wknow
Cases receivedReports submitted
Shared by every model

What you get, whichever model you choose.

Every OnePV application

Safety Vault, IntakeIQ, GatewayPRO, AggregatePRO and SignalIQ, in every model.

Regulatory submissions

E2B(R3) to EMA, FDA, MHRA, Health Canada and WHO PIDM from every model.

Dictionaries maintained once

MedDRA and reference data kept current centrally for every client.

One permission catalogue

The same roles and permissions everywhere, so audits read the same.

Upgrades by HAROM

Releases applied by HAROM across models, with change control.

Audit trail everywhere

Every action in every client and in the control office is recorded.

Compare

Which model fits.

Best forCROs and PV service providersMid-size pharma and MAHsTop-tier pharma and groups
AddressOne address for the CROYour own addressYour own address
DataA segregated database per clientYour own databaseDedicated server and databases
UsersYour team, same role across clients; Microsoft sign-inYour users, your rolesYour users, your roles
OnboardingHAROM provisions each client; open to your team immediatelyProvisioned by HAROM, ready quicklySet up and reviewed by HAROM
UpgradesApplied by HAROMApplied by HAROMPushed by HAROM
Onboarding

From agreement to first case.

  1. 1

    Choose the model

    A short conversation on how you operate today and where you are going.

  2. 2

    We provision

    Client, address, users, products and reference data, reviewed before set-up runs.

  3. 3

    Train and go live

    Role-based training with assessed competency, then your first cases.

  4. 4

    Run with HAROM behind you

    Platform support included; PV services added whenever you need capacity.

Security controls

The same controls in every model.

Designed to support 21 CFR Part 11 and EU Annex 11 controls.

  • Role-based access

    Everyone sees exactly what their role allows.

  • Audit trail on every action

    Who, what and when — always on record.

  • MFA or one-time code, enforced

    Every sign-in verified twice.

  • Strict password policy

    Strong, rotated, enforced.

  • Controlled workflows

    Nothing skips a step.

Who we onboard

Built to onboard CROs, mid-size pharma and top-tier pharma.

CROs and service providers

Offer pharmacovigilance to your clients behind your own address, without building a platform.

Mid-size pharma and MAHs

Your own tenant on a platform that already runs multi-market submissions.

Top-tier pharma

A dedicated instance with the isolation your security and residency policies require.

Next step

Tell us how you run PV. We will show you the model that fits.

A HAROM PV expert walks you through the control office, the CRO dashboard and the applications on your own workflow.