Clinical Development Outsourcing
Senior expertise. Flexible engagement. Real impact
Access highly experienced clinical development professionals who strengthen your team, oversee vendors and support critical development milestones — without the commitment of permanent hiring.
Whether you need strategic leadership, operational expertise, regulatory support or specialized functional services, ExperTrials provides flexible access to senior experts who integrate seamlessly into your organization.
No Upfront recruitment or placement fees—just one transparent, all-inclusive hourly rate.
Years Supporting Biotech Innovation
Years Average Industry Experience
%
Repeat Business
Europe & US Coverage
The right expertise. The right level of support.
Exactly when you need it.
Trusted by biotech innovators.
We provide flexible access to specialized expertise exactly when and where you need it — from early development through to pivotal trials and beyond.
Independent sponsor-side oversight of CROs and clinical vendors to protect quality, timelines, budgets and regulatory compliance.
Services include :
- CRO and vendor selection and due diligence
- Governance and oversight plan development
- KPI, KRI, milestone and budget tracking
- Vendor performance reviews and governance meetings
- Risk, issue, escalation and CAPA follow-up
- Independent quality and compliance oversight
Typical Profiles :
- Clinical Oversight Manager
- Sponsor Representative
- Vendor Manager
- Clinical Program Lead
Senior operational support to coordinate the path from country and site selection through to site readiness and activation.
Services include :
- Country and site feasibility assessments
- Study start-up strategy, planning and tracking
- Investigator and site document collection
- Site contract and budget negotiations
- Clinical trial insurance coordination
- Site readiness assessment and activation
Typical Profiles :
- Study Start-Up Lead
- Country Start-Up Specialist
- Site Contract Specialist
- Regulatory Start-Up Specialist
Executive-level clinical leadership available on a flexible basis for biotech and medtech companies that do not require a permanent full-time appointment.
Services include :
- Clinical development and operational strategy
- Organizational design and resource planning
- Team leadership, coaching and mentoring
- Vendor selection, governance and oversight
- Portfolio, budget and risk oversight
- Board, investor and regulatory meeting support
Typical Profiles :
- Fractional Chief Development Officer
- Fractional VP Clinical Operations
- Fractional Head of Clinical Operations
- Clinical Program Lead
Experienced clinical trial managers providing study-level leadership from planning and feasibility through database lock and close-out.
Services include :
- Study planning and execution
- Cross-functional study team leadership
- Timeline, milestone and budget oversight
- Site activation, recruitment and performance oversight
- Vendor coordination and sponsor reporting
- Risk, issue and change management
Typical Profiles :
- Clinical Trial Manager
- Senior Project Manager
- Global Project Manager
- Program Manager
Strategic and operational regulatory expertise supporting clinical development programs across Europe and North America.
Services include :
- Regulatory strategy and development roadmaps
- CTA, IND and CTIS submission support
- Health Authority, Ethics Committee and IRB interactions
- Regulatory responses, amendments and notifications
- Regulatory document preparation, review and quality control
- Transparency, CCI and personal data redaction reviews
Typical Profiles :
- Regulatory Affairs Manager
- Regulatory Strategist
- Regulatory Submission Specialist
- CTIS Specialist
Integrated pharmacovigilance support to ensure timely safety reporting, regulatory compliance and continuous evaluation of the study’s safety profile.
Services include :
- Safety Management Plan and PV process development
- SAE and SUSAR processing and expedited reporting
- Medical coding and safety narrative preparation
- Clinical and safety database reconciliation
- Signal detection and safety trend analysis
- DSUR, PBRER and aggregate safety reporting
Typical Profiles :
- Head of Pharmacovigilance
- Pharmacovigilance Physician
- Safety Manager
- Drug Safety Specialist
Senior-led site management and monitoring to maintain protocol compliance, data quality and consistent site performance throughout the trial.
Services include :
- Monitoring strategy and Monitoring Plan development
- Site initiation, monitoring and close-out visits
- Remote monitoring and centralized oversight
- Site training and ongoing operational support
- Recruitment, retention and site performance follow-up
- Protocol deviation, action item and escalation management
Typical Profiles :
- Lead CRA
- Senior CRA
- In-House CRA
- Site Manager
Physician-led medical oversight to protect participants, support investigators and maintain informed benefit–risk evaluation throughout the study.
Services include :
- Medical review of protocols and study documents
- Patient eligibility and clinical case review
- Investigator medical support and issue resolution
- Medical review of safety events, laboratory results and ECGs
- Clinical trend and benefit–risk evaluation
- Safety Review Committee and DSMB/DMC support
Typical Profiles :
- Medical Director
- Lead Medical Monitor
- Medical Monitor
- Clinical Scientist
Independent, risk-based quality oversight designed to maintain regulatory compliance and continuous inspection readiness.
Services include :
- Quality Management Plan and RBQM development
- Vendor, site and study process audits
- Trial Master File quality and completeness reviews
- GCP, protocol and SOP compliance oversight
- Deviation, root-cause analysis and CAPA management
- Mock inspections, inspection preparation and response support
Typical Profiles :
- Fractional Head of Quality Assurance
- QA Manager
- GCP Auditor
- Inspection Readiness Lead
Integrated data management and biostatistical expertise to transform clinical data into reliable, analysis-ready evidence.
Services include :
- Data Management Plan development
- CRF and eCRF design, database build and validation
- Edit-check programming and user acceptance testing
- Data cleaning, coding, reconciliation and external data integration
- Database freeze, lock and archival support
- Statistical design, SAP development, programming, analyses and TLF production
Biostatistics services include:
- Head of Data Management & Biostatistics
- Lead Data Manager
- Data Manager Programmer
- Biostatistician
- Statistical Programmer
Qualified independent translators and interpreters with experience in clinical research, GCP terminology and regulated environments.
Services include :
- Translation of clinical, regulatory and quality documents
- Independent linguistic review and back-translation
- Interpretation during regulatory inspections
- Interpretation during audits and mock inspections
- Investigator and Health Authority meeting support
- On-site and remote multilingual assistance
Typical Profiles :
- Clinical Translator
- Regulatory Translator
- Audit Interpreter
- Inspection Interpreter
Flexible Engagement Models
ExperTrials offers multiple engagement models depending on your needs.
Full-Time Equivalent (FTE)
Dedicated expert supporting your program on a full-time basis.
Part-Time Fractional Support
Access senior expertise on a flexible monthly allocation.
Project-Based Engagement
Specialized support for defined deliverables and milestones.
Interim Leadership
Temporary executive support during periods of growth, transition or organizational change.
Why Choose ExperTrials ?
ExperTrials offers multiple engagement models depending on your needs.
Senior-Only Experts
Our consultants bring 15–30+ years of clinical development experience.
Deep Therapeutic Expertise Strong experience across :
Oncology-CNS - Rare Diseases - Autoimmune - iseases - Infectious Diseases - Cardiology - Gastroenterology - Advanced Therapies
Available Within Days
Rapid deployment of experienced professionals.
Europe & US Coverage
Access experienced professionals across Europe and North America.
Flexible Engagement Models
Scale expertise up or down according to your development needs.
Quality & Compliance at the Core
All consultants operate within ExperTrials' Quality Management System and follow established SOPs and compliance processes.
No Upfront Recruitment Fees
ExperTrials is an outsourcing partner—not a recruitment agency. We do not charge an initial recruitment or placement fee.
Our transparent hourly rate is all-inclusive, covering expert compensation, selection and qualification, contracting, administrative coordination, invoicing and ongoing assignment support.
Need Clinical Expertise Without Increasing Headcount?
ExperTrials provides immediate access to experienced clinical development professionals who can strengthen your team, accelerate execution and reduce operational risk.
