Clinical Development Network Across Global Newsroom Participants Member Login Submit an RFP

Solutions · Pharmacovigilance | Drug Safety and Risk Management | Guosa Life Sciences

Advancing Patient Safety Through Continuous Vigilance

Q: Do you provide medical review and signal detection?

Yes, medical review, aggregate reporting, and signal detection are integral to our PV services, supported by qualified safety physicians and scientists.

Integrated Pharmacovigilance Across the Product Lifecycle

Patient safety is the foundation of responsible clinical development. As therapies become more innovative and regulatory expectations evolve, pharmacovigilance must extend beyond reporting to become a strategic function supporting informed decisions, risk management and public confidence.

Submit an RFP

Home/Solutions/Pharmacovigilance | Drug Safety and Risk Management | Guosa Life Sciences

Overview

Integrated Pharmacovigilance Across the Product Lifecycle

Guosa Life Sciences delivers comprehensive PV services integrating safety surveillance, medical review, regulatory reporting, risk management and signal detection throughout the lifecycle.

Our multidisciplinary approach combines scientific expertise, regulatory knowledge and technology-enabled processes to ensure timely safety evaluation and global compliance.

Drug safety monitoring and signal detection

Capabilities

What We Deliver

Safety Operations

Adverse event management
Case processing
Medical review
Aggregate reporting

Risk and Signals

Signal detection
Risk management planning
Safety surveillance
Regulatory safety reporting

The GLS Advantage

Strengthened by the Whole Enterprise

Every solution delivered by Guosa Life Sciences is strengthened by the broader enterprise. Our operational teams are supported by evidence-based Insights, professional development through GLS Academy, collaborative partnerships within the Clinical Development Network and a quality-driven delivery model, enabling scientifically sound, operationally efficient and scalable solutions.

Explore the Enterprise

Evidence-based Insights
GLS Academy development
Clinical Development Network
Integrated quality systems
Technology-enabled delivery
Global operational reach

The capability

What We Actually Do

We manage safety across the study lifecycle: case intake and processing, medical review, expedited and periodic regulatory reporting, signal detection and evaluation, risk management plan support, and safety database configuration and oversight.

The operational challenge in multi-country studies is rarely case processing itself. It is ensuring that every site knows what to report, to whom and in what timeframe, and that the answer is right for that country rather than borrowed from another. We build the reporting matrix at start-up, train sites against it, and hold it current as countries change requirements mid-study.

Regulatory considerations

Expedited reporting across non-ICH jurisdictions

Expedited reporting timelines diverge more than sponsors expect once a study leaves ICH jurisdictions. Seven and fifteen day clocks are common but not universal, the trigger event for starting the clock differs, and several authorities require submission in local format or language regardless of what was filed elsewhere. Some require notification of events that would not be expedited under ICH rules at all.

Annual safety reporting compounds the difference. Development safety update reports may need country-specific cover documents, local ethics committees frequently require separate submission on their own cycle, and end-of-trial safety notifications vary in both content and deadline. A single global process applied uniformly will be non-compliant somewhere; we maintain the matrix country by country and reconcile it against the study's actual footprint at each amendment.

How an engagement runs

The Sequence

1. Safety plan and reporting matrix

Country-by-country expedited and periodic requirements, formats, languages and recipients, agreed before first patient in.

2. Case processing

Intake, coding, medical review and quality control against defined timelines, with escalation for events requiring urgent assessment.

3. Regulatory reporting

Expedited submissions to every applicable authority and ethics committee, with periodic reports on each local cycle.

4. Signal management

Ongoing detection and evaluation, with documented decisions and risk management updates where a signal is confirmed.

What you receive

Deliverables

A country-specific safety reporting matrix. Processed and medically reviewed cases within agreed timelines. Expedited and periodic submissions with proof of receipt. A documented signal detection and evaluation record.

Evidence and context

The Research Behind This Work

Our operating assumptions are published rather than asserted. The Future of Clinical Trials in Africa sets out why study performance is increasingly determined by ecosystem maturity rather than site selection, and The Untapped Advantage makes the case that institutions, not regions, are the right unit of qualification. Both are available in full, with executive briefs for readers who want the argument in a shorter form.

The Future of Clinical Trials in Africa The Untapped Advantage

Quality Assurance

Safety compliance.

Explore

Data and Biostatistics

Safety data.

Explore

Regulatory Affairs

Safety reporting.

Explore

Medical Writing

Safety narratives.

Explore

FAQ

Common Questions

Do you provide medical review and signal detection?

Yes, medical review, aggregate reporting and signal detection are integral to our PV services, supported by qualified safety physicians and scientists.

Can you support both clinical-trial and post-marketing safety?

Yes. Our pharmacovigilance services span the full product lifecycle, from clinical development through post-marketing surveillance.

Let's Discuss Your Program

Tell us about your objectives and our multidisciplinary team will scope an integrated, flexible solution.

Submit an RFP

Advancing Patient Safety Through Continuous Vigilance

Integrated Pharmacovigilance Across the Product Lifecycle

What We Deliver

Safety Operations

Risk and Signals

Strengthened by the Whole Enterprise

What We Actually Do

Expedited reporting across non-ICH jurisdictions

The Sequence

1. Safety plan and reporting matrix

2. Case processing

3. Regulatory reporting

4. Signal management

Deliverables

The Research Behind This Work

Explore Related Capabilities

Quality Assurance

Data and Biostatistics

Regulatory Affairs

Medical Writing

Common Questions

Let's Discuss Your Program