STUDY TYPE
Phase 1, Controlled Human Infection Model (CHIM) trial
LOCATION
Europe, UK, Australia
CLIENT
Biotech
Client Challenge
The need for scalable safety services for vaccine clinical trials became critical for a small-sized biotech, running multiple respiratory vaccine trials. With short timelines and lack of an in-house pharmacovigilance department or safety systems in place, they needed trained, knowledgeable resources who could seamlessly integrate into their team and act on their behalf. Setting up an internal pharmacovigilance group would have required significant time, resources and budget. Instead, the client chose to partner with P95 to provide full safety management services across their clinical trials.
A full-serivce pharmacovigilance solution without the overhead
To meet the client’s needs, P95 deployed an experienced safety and pharmacovigilance team to provide end-to-end safety management. We delivered:
- End-to end safety oversight, from case handling to signal detection and regulatory reporting
- Flexible service model, operating under P95’s SOPs or co-developing customized procedures to align with the client’s internal framework.
- A committed safety team with extensive operational and therapeutic experience, particularly on vaccines and infectious diseases
- Access to secure and validated safety databases to ensure robust data integrity and regulatory compliance
- Experience in navigating different country and regional regulatory requirements
- Safety and pharmacovigilance experts who integrate seamlessly and work as an extension of the client’s team
Without having to start from scratch with internal systems and teams, our method allowed the client to meet safety regulations and keep the momentum of the trial going.
Results and IMPACT: Scalable safety services for vaccine clinical trials
The partnership with P95 delivered tangible advantages across multiple dimensions of clinical trial execution and safety management.
- End-to-end oversight of all trials enabled deeper understanding of product and its safety profile
- Trials were consistent meaning less variability, lower risk, and improved operational flow
- Validated systems and regulatory expertise accelerated trial timelines while ensuring full global compliance
- Real-time access to safety and pharmacovigilance specialists allowed the client to act quickly and confidently on safety issues
- Experience with complex regulatory environments meant the client was fully prepared for audits and submissions
FAQ
Here are some answers to Frequently Asked Questions.
What clinical safety services does P95 offer?
P95 delivers comprehensive safety and pharmacovigilance services that support all stages of a clinical trial. This includes Preparation of Safety Management Plan, 24 / 7 Safety Desk, SAE Management, Data Entry in Safety Database, Query Management, Expedited Reporting (SUSAR Management) including Eudra Vigilance Reporting, Annual Safety Reporting (DSUR), Participation in Data Safety Monitoring Board Meetings, Medical Monitoring
How did P95’s approach improve trial performance and outcomes?
By partnering with P95, the client maintained trial momentum and met all safety requirements, without having to build an internal system or systems from scratch.
How can a biotech start their partnership with P95?
Reach out to our experts team via https://p-95.com/contact-us/. We will connect you directly to discuss your trial requirements and determine the best approach to support your goals.
Does P95 provide full-service solutions for biotech?
P95 offers both full-service and partial-service models, so that a client can scale based on their need. Our clients range from biotech, pharmaceutical and not-for profit organizations. We have 25 years of experience working with a diverse range of clients worldwide in different therapeutic areas.
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