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
The Clinical Trial Journey
A comprehensive, end-to-end approach to clinical research, from site activation to real-world evidence.
Site Selection & Activation
Site Identification and Profiling
Utilizing data-driven feasibility assessments to pinpoint high-performing sites and ideal patient populations.
Site Selection & Activation
Site Qualification Visits (SQV)
Conducting thorough evaluations of facility infrastructure, staff expertise, and equipment capabilities.
Site Selection & Activation
Investigator and KOL Engagement
Building strong relationships with Key Opinion Leaders and principal investigators to drive study success.
Site Selection & Activation
IRB/Ethics and Regulatory Submissions
Managing localized ethics committee approvals and regulatory documentation for rapid site activation.
Site Selection & Activation
Site Initiation Visits (SIV) and Training
Ensuring all site personnel are fully trained on study protocols, GCP, and electronic systems before trial commencement.
Site Monitoring & Oversight
Risk-Based Monitoring (RBM)
Implementing adaptive, centralized monitoring strategies to identify and mitigate risks proactively.
Site Monitoring & Oversight
Interim Monitoring Visits (IMV)
Conducting regular on-site or remote visits to verify source data, assess protocol compliance, and resolve queries.
Site Monitoring & Oversight
Source Data Verification (SDV) & Review (SDR)
Ensuring absolute data integrity by cross-referencing EDC entries with original patient records.
Site Monitoring & Oversight
IMP and Clinical Supply Accountability
Overseeing the secure storage, dispensing, and tracking of Investigational Medicinal Products at the site level.
Site Monitoring & Oversight
Protocol Deviation Management
Identifying, documenting, and implementing corrective and preventive actions (CAPA) for any protocol deviations.
Site Patient Support
Site-Specific Recruitment Planning
Developing localized patient outreach strategies tailored to the unique demographics of each site.
Site Patient Support
Patient Concierge and Travel Services
Reducing dropout rates by managing participant travel, and stipend reimbursements.
Site Patient Support
Community Practice and GP Integration
Expanding trial access by integrating local primary care physicians and community clinics into the site network.
Site Patient Support
Pre-Screening and Enrollment Tracking
Implementing robust initial vetting processes to ensure only highly qualified candidates reach the randomization phase.
Site Close-Out & QA
Site Close-Out Visits (COV)
Managing the final reconciliation of data, drug supplies, and documentation to officially close trial sites.
Site Close-Out & QA
Database Lock Preparation
Collaborating with data management teams to accelerate query resolution and ensure a clean, timely database lock.
Site Close-Out & QA
Inspection Readiness and Auditing
Conducting mock audits and comprehensive QC checks to ensure sites are fully prepared for regulatory inspections.
Site Close-Out & QA
eTMF Reconciliation
Verifying that the electronic Trial Master File is complete, accurate, and inspection-ready at the site level.
Site Close-Out & QA
Investigator Payment Management
Automating and tracking accurate, milestone-based financial reimbursements to sites and investigators.
Phase IIIb/IV Trials
Phase IIIb/IV Pragmatic Trials
Designing large-scale, post-approval studies to gather safety and efficacy data in real-world clinical settings.
Phase IIIb/IV Trials
Label Extension Studies
Generating robust clinical evidence required by regulatory bodies to expand a product’s approved indications.
Phase IIIb/IV Trials
Post-Marketing Safety Surveillance
Conducting continuous pharmacovigilance to detect, monitor, and report long-term or rare adverse events.
Phase IIIb/IV Trials
Comparative Effectiveness Research (CER)
Evaluating how a new therapy compares to existing standard-of-care treatments in real-world scenarios.
Phase IIIb/IV Trials
Compassionate Use and Early Access Programs
Managing ethical pathways to provide pre-approval access to experimental drugs for patients with unmet medical needs.
Observational & RWE
Non-Interventional Cohort Studies
Executing prospective observational studies where patients are treated according to standard clinical practice.
Observational & RWE
Retrospective Chart Reviews
Analyzing existing medical records and historical data to identify treatment patterns and historical control cohorts.
Observational & RWE
Disease and Product Registries
Building and managing longitudinal databases to track patient outcomes, disease progression, and long-term safety.
Observational & RWE
Electronic Health Record (EHR) Analytics
Extracting and standardizing vast amounts of unstructured healthcare data to generate actionable Real-World Evidence.
Observational & RWE
Wearable and ePRO Integration
Collecting continuous, real-time physiological data and patient-reported outcomes outside of traditional clinical settings.
Health Economics (HEOR)
Health Economics and Outcomes Research (HEOR)
Generating economic models and value dossiers to support pricing, reimbursement, and market access strategies.
Health Economics (HEOR)
Quality of Life (QoL) Assessments
Validating and analyzing the direct impact of therapies on patients' daily lives and overall wellbeing.
Health Economics (HEOR)
Post-Authorization Safety Studies (PASS)
Fulfilling mandatory regulatory requirements to evaluate specific safety concerns post-approval.
Health Economics (HEOR)
Post-Authorization Efficacy Studies (PAES)
Collecting supplementary data to confirm the ongoing efficacy of a drug within the general population.
Health Economics (HEOR)
Cost-Effectiveness Analysis
Demonstrating the economic value of a therapy to healthcare payers, HTA bodies, and formulary committees.
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