Full-Service CRO End-to-end clinical trial execution for biotech innovators.
From feasibility to database lock, ExperTrials provides agile, senior-led clinical trial management across Europe and North America.
Whether you are preparing a Phase I study, launching a global Phase III program or managing a registration-enabling trial, our experienced team provides the operational expertise, regulatory guidance and quality oversight needed to successfully deliver your clinical development program.
Years Supporting Biotech Innovation
Years Average Industry Experience
%
Repeat Business
Europe & US Coverage
One partner. One coordinated strategy.
Complete study delivery.
Integrated regulatory and start-up management to move your study efficiently from development strategy to site activation
Services include :
- Regulatory strategy and clinical development planning
- Country and site feasibility assessments
- Protocol, Investigator’s Brochure and essential document support
- CTA, IND and CTIS submission preparation and management
- Health Authority, Ethics Committee and IRB interactions
- Site contracts, budgets, insurance and activation coordination
Senior-led clinical operations ensuring consistent study execution, site performance and protocol compliance from initiation through close-out.
Services include :
- Clinical project management and cross-functional coordination
- Study plans, governance structures and operational timelines
- Investigator and site selection, qualification and training
- Site initiation, monitoring and close-out visits
- Recruitment, retention and site performance management
- Risk, issue, budget, vendor and milestone oversight
Integrated data and statistical services designed to produce reliable, traceable and analysis-ready clinical evidence.
Data Management :
- Data Management Plan and statistical strategy development
- CRF and eCRF design, database build and validation
- Edit-check programming and user acceptance testing
- Data cleaning, medical coding and external data reconciliation
- Statistical Analysis Plan, programming, analyses and TLF production
- Database freeze, lock, archival and final data delivery
Physician-led medical oversight and integrated pharmacovigilance to protect participants and maintain continuous evaluation of the study’s safety profile.
Medical & Safety :
- Medical review of protocols and clinical study documents
- Patient eligibility and complex clinical case review
- Medical support for investigators and study teams
- SAE assessment, case processing and SUSAR reporting
- Safety database reconciliation and signal evaluation
- DSUR preparation and Safety Review Committee or DSMB/DMC support
Independent, risk-based quality oversight supporting regulatory compliance, data integrity and continuous inspection readiness.
Services include :
- Quality Management Plan and RBQM implementation
- GCP, protocol, SOP and regulatory compliance oversight
- Trial Master File quality and completeness reviews
- Site, vendor, system and study process audits
- Deviation, root-cause analysis and CAPA management
- Mock inspections, inspection preparation and response support
Why Choose ExperTrials ?
15+ Years Supporting Biotech Innovation
Trusted partner for emerging and established biotech companies.
95% Repeat Business
Long-term relationships built on quality, transparency and performance.
24 Countries Covered
Operational capabilities across Europe and North America.
Senior-Only Model
Every project is led by highly experienced clinical development professionals.
ISO 9001 Certified
Quality Management System focused on continuous improvement and operational excellence.
FDA & EMA Experience
Extensive experience supporting registration-enabling clinical development programs.
30+ Clinical Trials
Delivered across multiple therapeutic areas.
Single Point of Accountability
One integrated team overseeing your study from strategy and start-up through execution and close-out.
Phase I-IV Experience
Supporting development from first-in-human through registration.
Our End-To-End Process
PLAN
Protocol review, feasibility and country strategy.
Activities :
- Clinical monitoring
- Project management
- Vendor management
- Recruitment oversight
- Risk management
LAUNCH
Regulatory approvals and site activation.
Activities :
- Regulatory submissions
- Ethics Committee approvals
- Site contracts
- Site initiation visits
- Vendor onboarding
EXECUTE
Monitoring, project management and vendor oversight.
Activities :
- Clinical monitoring
- Project management
- Vendor management
- Recruitment oversight
Risk management
CLOSE-OUT
Database lock, CSR support and inspection readiness.
Activities :
- Database lock
- Statistical reporting
- CSR support
- Inspection preparation
- Trial close-out
Therapeutic Expertise
ExperTrials has extensive experience supporting Phase I-IV clinical trials across multiple therapeutic areas
Oncology
Solid tumors, hematology, immuno-oncology, neuro-oncology and precision medicine.
CNS
Stroke, glioblastoma, epilepsy, multiple sclerosis, neurodegenerative diseases and rare neurological disorders.
Rare Diseases
International orphan drug programs and specialized patient populations.
Advanced Therapies & Medical Devices
Cell therapies, gene therapies, ATMPs and innovative medical technologies.
Infectious Diseases
Anti-infectives, vaccines and complex global infectious disease programs.
Cardiology
Heart failure, coronary artery disease, interventional cardiology and cardiovascular devices.
Infectious Diseases
Anti-infectives, vaccines and complex global infectious disease programs.
Autoimmune Diseases
Inflammatory and immune-mediated diseases including dermatology and rheumatology programs.
Gastroenterology
Inflammatory bowel disease, rare gastrointestinal disorders and digestive health programs.
Need a CRO that feels like an extension of your team?
ExperTrials combines the agility of a specialist consultancy with the operational capabilities of a full-service CRO.
Our senior experts work alongside your team to deliver clinical trials efficiently, transparently and with a strong focus on quality.
