Merakee BI Analytics Ltd.

Dedicated pharmacovigilance consulting — safety systems, analytics, dashboards, data migration and extraction, and AI development for drug safety teams.

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Email info@merakeebi.com

Phone +1 647 854 1079

Office 600 Matheson Blvd W, Unit 5, Mississauga, ON L5R 4C1, Canada

Home · Analytics · Dashboards · Safety Consulting · Data Migration · Data Extraction · AI Development · Contact

SAFETY SYSTEMS CONSULTING

Techno-functional support for the full safety system lifecycle.

Senior, hands-on PV expertise across configuration, upgrades, vendor selection, and training — from a team that’s 100% dedicated to pharmacovigilance.

Request a safety system readiness review
WHERE WE COME IN
Selection and implementation
project
RFP coordination · Requirement definition · Vendor evaluation · Solution assessment · Implementation planning
Configuration
per change
Product, licence and study setup · Codelist management · Reporting rules · Workflow and E2B configuration
Change control
every change
Dual assessment and approval · Regulatory guideline impact · Validation evidence · Production sign-off
Upgrades and vendor oversight
per release
Argus upgrades · Hosting and IT vendor management · Release and SLA oversight · Dictionary versions
SYSTEMS
ArgusARISgLSMV
CONTROL WITHOUT BREAKING EVIDENCE

A minute on changing a safety system without breaking its evidence.

Two independent approvals, four impact domains scored before anything is touched, the validation environment first and production second, a dictionary upgrade simulated rather than loaded — and knowing where to take automation back out.

HOW WE WORK INSIDE A VALIDATED SYSTEM
WHERE WE HELP

Senior people, inside your system.

Techno-functional work that needs someone who understands both the safety process and the system underneath it.

Implementation and upgrade support
Scoping, configuration review and cutover for safety system changes.
Configuration and workflow
Case workflow, user roles, coding and reporting rules reviewed against how the team actually works.
Change control and sign-off
Changes assessed, documented and taken through approval on your behalf.
Vendor and release management
Translating between the business and the system vendor across releases and defects.
Reporting and rule review
Regulatory reporting rules and their behaviour checked against the obligation.
Dictionary and version upgrades
MedDRA and dictionary upgrades planned, applied and evidenced.
HOW AN ENGAGEMENT RUNS

Assessed, approved, then evidenced.

Inside a validated system nothing changes because it seemed sensible. Every step leaves a record behind it.

Step 01
Assess
What is changing, what it touches, and what the risk is.
Step 02
Specify
The change written down before it is made.
Step 03
Approve
Through change control, with the right approvers.
Step 04
Apply and test
Executed in a controlled environment, then verified.
Step 05
Evidence it
Records filed so the change survives an inspection.
SYSTEMS AND COVERAGE

The systems safety teams actually run.

We work inside the platforms already in place rather than recommending a replacement.

SAFETY SYSTEMSArgus SafetyARISg / IRTLSMVClinical safety systems
AROUND THEMSignal management toolsReporting and analytics layersInterfaces and gatewaysDocument systems
ACTIVITIESImplementationUpgradeMigration supportChange controlVendor oversight

Ready to strengthen your safety systems?

Talk to a PV specialist about your Argus, ARISg, or LSMV environment.

Request a safety system readiness review
WHAT’S INCLUDED
Techno-functional PV SMEs
Safety vendor management
System upgrade consulting
Safety system configuration
E2B customizations
Change management
MedDRA and WHODrug upgrade impact assessment
Tool / vendor selection RFPs
Safety operations optimization
Health authority guideline updates
Training materials
Merakee BI — Dedicated PV Consulting

Dedicated PV consulting for safety systems, analytics, dashboards, migration and AI development.
CONTACT
600 Matheson Blvd W Unit 5, Mississauga, ON L5R 4C1, Canada
© 2020–2026 Merakee BI Analytics Ltd.
Mississauga, Ontario, Canada
SAFETY SYSTEMS CONSULTING

Techno-functional support for the full safety system lifecycle.

Senior, hands-on PV expertise across configuration, upgrades, vendor selection, and training — from a team that’s 100% dedicated to pharmacovigilance.

Request a safety system readiness review
WHERE WE COME IN
Selection and implementation
project
RFP coordination · Requirement definition · Vendor evaluation · Solution assessment · Implementation planning
Configuration
per change
Product, licence and study setup · Codelist management · Reporting rules · Workflow and E2B configuration
Change control
every change
Dual assessment and approval · Regulatory guideline impact · Validation evidence · Production sign-off
Upgrades and vendor oversight
per release
Argus upgrades · Hosting and IT vendor management · Release and SLA oversight · Dictionary versions
SYSTEMS
ArgusARISgLSMV
CONTROL WITHOUT BREAKING EVIDENCE

A minute on changing a safety system without breaking its evidence.

Two independent approvals, four impact domains scored before anything is touched, the validation environment first and production second, a dictionary upgrade simulated rather than loaded — and knowing where to take automation back out.

HOW WE WORK INSIDE A VALIDATED SYSTEM
WHERE WE HELP

Senior people, inside your system.

Techno-functional work that needs someone who understands both the safety process and the system underneath it.

Implementation and upgrade support
Scoping, configuration review and cutover for safety system changes.
Configuration and workflow
Case workflow, user roles, coding and reporting rules reviewed against how the team actually works.
Change control and sign-off
Changes assessed, documented and taken through approval on your behalf.
Vendor and release management
Translating between the business and the system vendor across releases and defects.
Reporting and rule review
Regulatory reporting rules and their behaviour checked against the obligation.
Dictionary and version upgrades
MedDRA and dictionary upgrades planned, applied and evidenced.
HOW AN ENGAGEMENT RUNS

Assessed, approved, then evidenced.

Inside a validated system nothing changes because it seemed sensible. Every step leaves a record behind it.

Step 01
Assess
What is changing, what it touches, and what the risk is.
Step 02
Specify
The change written down before it is made.
Step 03
Approve
Through change control, with the right approvers.
Step 04
Apply and test
Executed in a controlled environment, then verified.
Step 05
Evidence it
Records filed so the change survives an inspection.
SYSTEMS AND COVERAGE

The systems safety teams actually run.

We work inside the platforms already in place rather than recommending a replacement.

SAFETY SYSTEMSArgus SafetyARISg / IRTLSMVClinical safety systems
AROUND THEMSignal management toolsReporting and analytics layersInterfaces and gatewaysDocument systems
ACTIVITIESImplementationUpgradeMigration supportChange controlVendor oversight

Ready to strengthen your safety systems?

Talk to a PV specialist about your Argus, ARISg, or LSMV environment.

Request a safety system readiness review
WHAT’S INCLUDED
Techno-functional PV SMEs
Safety vendor management
System upgrade consulting
Safety system configuration
E2B customizations
Change management
MedDRA and WHODrug upgrade impact assessment
Tool / vendor selection RFPs
Safety operations optimization
Health authority guideline updates
Training materials
Merakee BI — Dedicated PV Consulting

Dedicated PV consulting for safety systems, analytics, dashboards, migration and AI development.
CONTACT
600 Matheson Blvd W Unit 5, Mississauga, ON L5R 4C1, Canada
© 2020–2026 Merakee BI Analytics Ltd.
Mississauga, Ontario, Canada