Bring Life-Changing Pharmaceutical Therapies To
The 🇬🇧 Market The 🇬🇧 Market
We partner with pharmaceutical leaders to execute clinical trials with rapid enrollment, high retention, and uncompromising data quality.
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Bring Life-Changing Pharmaceutical Therapies To
Trusted Partners
For Sponsors
Clinical Trial Services
Expertise to handle any stage of the clinical research life-cycle.
Assisted trial design
Study Startup
Strategic consultation to optimize your study endpoints and methodology for maximum clinical impact.
Protocol writing
Study Startup
Developing scientifically rigorous and regulatory-compliant protocols tailored to your specific therapeutic area.
Site feasibility, selection, training and initiation
Study Startup
Identifying high-performing sites and ensuring teams are fully equipped to meet enrollment and safety targets.
IRB/ethics and regulatory submissions
Study Startup
Navigating complex global submission pathways to secure rapid approvals and maintain study timelines.
CTMS configuration and UAT
Study Startup
Setting up robust Clinical Trial Management Systems with thorough User Acceptance Testing for flawless operations.
Study plans
Study Startup
Crafting detailed operational roadmaps that align stakeholders and define clear paths to project milestones.
EMR databank querying
Patient Recruitment
Utilizing advanced Electronic Medical Record data to identify eligible participants with precision and speed.
Central digital advertising
Patient Recruitment
Running targeted multi-channel campaigns to reach diverse patient populations across digital platforms.
On-site patient recruitment
Patient Recruitment
Deploying specialist teams directly to clinical sites to facilitate face-to-face engagement and enrollment.
Study websites and marketing materials
Patient Recruitment
Designing patient-centric digital portals and high-quality printed materials to boost trial visibility.
Ready to discuss your clinical trial?
Connect with our experts to discuss how our integrated services can streamline your development timeline.
Protecting you & Safeguarding Volunteers
Bespoke Pharmacovigilance Solutions
Ensuring drug safety with a commitment to patient safety and regulatory excellence for small-to-mid size sponsors.
Adverse Event Reporting
- Streamlined reporting systems for adverse drug reactions (ADRs)
- End-to-end case processing and lifecycle management
- Real-time safety monitoring and signal identification
Regulatory Compliance
- Adherence to global pharmacovigilance regulations
- Customized solutions for local and international markets
- Audit preparation and inspection readiness
Literature Monitoring
- Comprehensive scientific literature surveillance
- Preparation of high-quality pharmacovigilance documentation
- Narrative writing, aggregate reports, and regulatory submissions
Risk Management Services
- Development and implementation of Risk Management Plans (RMPs)
- Periodic Safety Update Reports (PSURs) & Risk-Benefit Evaluation
- Proactive safety strategies for high-risk products
Signal Detection
- Advanced data mining and statistical safety analysis
- Early detection of emerging safety concerns
- Collaborative safety reviews with regulatory authorities
Inspection Readiness
- Inspection readiness training and internal audits
- Pharmacovigilance system master file (PSMF) support
- Mock inspections, interviews, and QPPV representation
Ready to secure your product's safety lifecycle?
Speak directly with our pharmacovigilance team to get a comprehensive review of your compliance gaps.
Contact Us
Visit Our Research Center
Our facility is easily accessible from the A5 and A422, offering dedicated parking for our volunteers and partners.
Primary Clinic Address
Unit F, Old Stratford Business Park, Falcon Drive, Old Stratford, Milton Keynes, MK19 6FG
Contact Reception
(+44) 1908 032992
cyprel@stemaxconsult.com