Safety & pharmacovigilance
Scientific and medical expertise during clinical development and post-marketing
Every clinical programme faces safety risks, from trial design to post-marketing signals. KLIFO helps you anticipate them, design lean safety frameworks and act with regulatory confidence. That’s how we keep your drug’s journey safe at every stage.
Safety & pharmacovigilance from protocol to post-marketing
At KLIFO, we help ensure your drug’s journey is safe — for your patients, while adhering to regulators, and protecting your business.
From first-in-human trials to post-marketing surveillance, we provide pharmacovigilance consulting that combines regulatory insight with scientific and medical excellence — always tailored to your asset, development phase and regulatory landscape.
How we work with you
Embedded collaboration and senior expertise define how we work.
We integrate seamlessly into your team, take responsibility when it matters most, and provide guidance, delivery and clear decisions — all from professionals who are experienced in and understand every stage of the drug development lifecycle.
Safety planning & governance
- Early-phase safety strategy: translating non-clinical findings into eligibility criteria, dosing strategies, monitoring schedules and stopping rules.
- Later-phase safety strategy: incorporate conclusions from early clinical trials into trial design and safety data handling (e.g. including AESI)
- Safety Management Plans (SMP): ensuring consistent safety oversight across all documents and processes.
- Safety governance structures: establishing and hosting DSMBs, DMCs and safety committees, including charter development.
Safety surveillance & signal management
- Ongoing medical safety monitoring throughout clinical development and post-marketing.
- Signal detection using literature surveillance, trend analysis and data mining.
- Evaluation of emerging safety signals and recommendations for regulatory action.
- Integration of EudraVigilance Data Analysis System (EVDAS) insights into decision-making.
Regulatory reporting & compliance
- Safety summary and patient leaflet: summarize safety data from all clinical activities and translate conclusions to the patient leaflet
- Investigator’s Brochure: Risk description and SAE expectedness for assessment of SUSAR reporting in Reference Safety Information (RSI). Ensure alignment with other regulatory documents, e.g. DSUR.
- Risk Management: Risk Management Plans (RMP, in EMA)/ Risk Evaluation and Mitigation Strategy (REMS in US) are required for marketing authorisation, with initiation suggested during phase 2 or 3. They include mitigation measures and regulatory alignment.
- Regulatory engagement: supporting scientific advice meetings and maintaining close dialogue with authorities including support in case of regulatory requests
- Periodic reports: DSUR (global), PSUR/PBRER (EMA), PADER (FDA) — tailored to meet global jurisdictional requirements.
- Urgent Safety Measures: Support in handling and communication
- Expedited reporting: compliant with CIOMS standards and local regulations.
- Alignment of safety reporting across multiple regions to avoid inconsistencies.
- Support for inspection readiness and PV audits.
Integrated case management (part of the bigger picture)
While case processing is not our core focus, it forms a natural part of an integrated safety strategy:
- SAE and AESI intake, triage and medical review.
- Coding using MedDRA/WHOdrug dictionaries.
- Narrative writing and ICSR management.
- Reconciliation between safety and clinical databases.
We ensure case management supports — rather than drives — the overall safety vision for your programme.
Post-marketing pharmacovigilance
- Continued safety surveillance for authorised products.
- Periodic safety updates, literature review and regulatory submissions.
- QPPV services providing fully compliant oversight for EU marketing authorisation holders.
Why companies choose KLIFO for pharmacovigilance consulting
We are not a traditional CRO focused on documentation for documentation’s sake. At KLIFO, our difference lies in our ability to bridge the gap between potential and approval:
- End-to-end expertise: From early-phase safety strategy to post-marketing obligations.
- Senior professionals only: Strategic guidance, scientific and medical insight with flawless execution.
- Embedded collaboration: Working with you, not just for you, and maintaining close dialogue with regulators.
- Tailored support: From ad hoc assignments to fully outsourced partnerships — powered by an agile structure that lets us step in when urgent needs arise.
Guidance through every phase
Real-world scenarios: how we help
Our role often begins at critical points in a project. Moments where strategic oversight and swift execution make all the difference. For example:
- A biotech preparing its first-in-human trial – KLIFO designs the safety strategy, risk mitigations and governance framework.
- A company lacking internal resources post-database lock – we author and submit DSURs to authorities on time.
- A sponsor managing multi-country safety reporting – we ensure consistency, compliance and clarity across jurisdictions.
Ready to get it right — from protocol to post-marketing?
If you need a partner who combines deep expertise, operational pragmatism and strategic oversight, let’s talk.
KLIFO is ready to step in when it truly counts.