Our ambition : to become your CRO of choice for future clinical trials
As a Contract Research Organization (CRO), ExperTrials provides clinical trial support to Biotech and Medtech companies, to help them launch their innovative drug or medical device. Discover those services, and what we can do for you - with you.
We are proud to deliver services that will contribute to improve millions of human lives.
Strategic Oversight to Manage and Monitor Every Aspect of Your Trial
✔️ Comprehensive Study Preparation – Development of study protocols, Investigator’s Brochure (IB), and IMPD review for regulatory compliance and scientific integrity
✔️ Optimized Recruitment & Retention – Targeted recruitment strategies to boost enrollment and minimize dropouts
✔️ Proactive Site & Risk Management – Efficient execution at each site through feasibility reviews and operationalized protocols. Risk prioritization to enable early mitigation, real-time issue resolution, and adaptive monitoring
✔️ Data-Driven Oversight – CTMS-powered decision-making and risk assessment, allowing for proactive and real-time performance tracking
✔️ Unparalleled Access to Leading Experts – Collaboration with globally recognized Key Opinion Leaders (KOLs) to strengthen trial design, execution, and credibility
Strategic Support for Seamless Clinical & Marketing Authorization in the US (FDA) & Europe (EMA)
✔️ Regulatory Intelligence & Compliance – Expert guidance on FDA & EMA regulations, ensuring full compliance with evolving legislation
✔️ Tailored Regulatory Strategies – Custom regulatory roadmaps to optimize approval timelines and mitigate risks
✔️ Efficient IND/CTA Preparation & Submission – Comprehensive support for accurate FDA (Investigational New Drug) & EMA (Clinical Trial Applications) filings
✔️ Seamless Multi-Country Submissions – Expert coordination & proactive follow-ups with FDA, EMA, Competent Authorities & Ethics Committees for faster approvals
✔️ Ongoing Trial Amendments & Compliance Management – Management of trial amendments and regulatory updates in line with FDA 21 CFR Part 312 & EMA CT Regulation (EU) No. 536/2014
✔️ Expedited Pathways – Guidance on securing Orphan Drug Designation (ODD), Pediatric Investigation Plans (PIP), and accelerated approval pathways (PRIME, Fast Track...)
Comprehensive clinical trial oversight, strategic consulting, and expert medical support
✔️ Review of Study Documents & Regulatory Input – Medical assessment of protocols, Clinical Study Reports (CSRs), and Case Report Forms (CRFs) with strategic FDA/EMA input
✔️ Safety Monitoring & SAE Assessment – Proactive review of all Serious Adverse Events (SAEs) and safety data for compliance with pharmacovigilance requirements
✔️ Access to Key Opinion Leaders & Advisory Panels – Strategic insights from leading experts to enhance trial design and credibility
✔️ 24/7 Medical Support – Continuous oversight and real-time decision-making for investigators and sites
✔️ Investigator & Site Selection / Training – Identification of high-performing investigators and sites, along with comprehensive protocol training
✔️ Protocol Compliance & Patient Eligibility – Rigorous assessment of deviations and inclusion/exclusion criteria to safeguard study integrity
✔️ Real-Time Data & Quality Management – Q&A logs tracking for issue resolution, medical review of ECGs, lab data, and safety signals...
Ensuring patient safety and regulatory compliance throughout your clinical development program
✔️ Safety Monitoring & Reporting – Continuous tracking of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), with patient narratives for clear regulatory context
✔️ Regulatory Safety Reporting – Preparation of Annual Safety Reports (ASRs) and Development Safety Update Reports (DSURs) per FDA, EMA & ICH guidelines, plus interim safety tracking
✔️ Data Accuracy & Signal Detection – SAE reconciliation to ensure consistency across databases. Participation in Safety Advisory Board (SAB) meetings for expert-driven safety risk assessment
✔️ Proactive Clinical Trial Risk Management – Risk-based pharmacovigilance strategies and standardized adverse event coding (MedDRA, WHO Drug)
✔️ Global PV Systems & Compliance – Secure pharmacovigilance database for case processing and regulatory compliance, plus EudraVigilance registration & reporting
To take care of all aspects of data capture and analysis
Our dedicated in-house team of Data Managers and Biostatisticians ensures seamless data capture and analysis throughout your clinical trial. We offer comprehensive services, including:
✔️ Biostatistics and Statistical Programming: Our experts handle activities such as SDTM, ADaM, TFL, ISS/ISE, Interim Analysis, IB/DSUR/DMC, FDA Briefing Book, publication support, PDF listing, and Smart Listing. We also perform data masking, data scrambling for blinded studies, and de-identification/anonymization based on specific regulatory requirements.
✔️ Data Management: Our in-house team oversees CRF design, clinical database build, medical coding (MedDRA and WHO Drug), SAE reconciliation, and Database Lock.
This approach ensures high-quality data management and statistical analysis, tailored to the unique needs of your clinical trial
Ensuring regulatory compliance, data integrity, and operational excellence
✔️ Quality Management System (QMS) – Continuous updates of Standard Operating Procedures (SOPs) & documented procedures to maintain compliance with ICH-GCP, FDA, EMA & MHRA regulations
✔️ Quality Assurance Training – Tailored QA programs & inspection/regulatory audits readiness support for vendors, sites & sponsors
✔️ Expert-led Quality Oversight – Dedicated Quality Assurance Specialists & risk-based quality management (RBQM) for proactive compliance
✔️ CAPA Management & Continuous Improvement – Corrective and Preventive Action (CAPA) plans, root cause analysis & preventive actions to enhance trial efficiency
✔️ Internal & External Auditing – Coordination of internal and external audits (sites, vendors & sponsors) to maintain high-quality standards
A trusted partner for regulatory compliance and data protection in the EU
✔️ Authorized EU Legal Representation – ExperTrials serves as your legal representative to ensure full compliance with EU CTR No. 536/2014, in any EU Member State
✔️ GDPR Compliance & Data Protection – Secure handling of EU personal & clinical trial data, thanks to our General Data Protection Regulation (GDPR) compliance
✔️ Regulatory Assurance & Risk Mitigation – Direct communication with EU regulatory authorities. Optimized data protection framework, ensuring audit readiness and ethical data handling within all applicable data protection laws
✔️ Secure International Data Transfers for Non-EU Sponsors – Lawful, secure cross-border data transfers using Standard Contractual Clauses (SCCs), encryption & Schrems II compliance strategies
Optimizing pricing, reimbursement, and value demonstration from the start
✔️ Strategic Trial Design for Market Access – Health Economics and Outcomes Research (HEOR) integration in Phase II/III to align endpoints with payer expectations & reimbursement needs
✔️ Market Access Strategy & Dossier Development – Tailored strategies & HTA submissions for global health authorities (NICE, HAS, IQWiG, ICER)
✔️ HEOR Data & Economic Modeling – Cost-effectiveness analysis, quality-adjusted life-year (QALY) assessments & budget impact studies to support reimbursement discussions
✔️ Real-World Evidence (RWE) Generation – Post-marketing studies & real-world data (RWD) leveraging to validate treatment effectiveness & patient outcomes
✔️ Epidemiology & Patient Insights – Disease burden analysis & predictive modeling to refine pricing & patient access strategies
« À la carte » services
✔️ Clinical Oversight Manager to assess your chosen CRO (sponsor’s responsibility as per ICH-GCP E6 (rev2))
✔️ Study Start-up Team for regulatory submissions and contract negotiations with Investigational Sites
✔️ Project Manager to manage your CRO or the vendors of your clinical study
✔️ Someone to manage your eTMF system
✔️ Partner for patients’ expenses reimbursement
LET'S TALK ABOUT OUR MODEL
Tailor-made, for Biotechs.
Agility
Our agility is our main strength. With a flat organisation structure, we ensure a simple and faster decision making and a direct access to senior leadership, fostering a high level of transparency and collaboration.
Thanks to our vast network of Experts, we can also quickly find the necessary resources if - for instance - the sponsor decides to open new countries. Moreover, we can guarantee a low turnover rate (less than 5%) due to the strong commitment from our Experts to each project.
Expertise & Cost-efficiency
We are cost-efficient and able to provide better services within your budget, as we made the choice of not having offices all over Europe, therefore our fixed expenses are rather low and flexible.
Our operational teams is only made up of Experts with a deep expertise. They all have senior profiles between 15 to 30 years experience in Clinical Research.
Quality
In Clinical Research, Standard Operating Procedures (SOPs) are essential to be in compliance with Good Clinical Practice (ICH-GCP) and local laws.
At ExperTrials, we have set up SOPs to be in total compliance with the international and national requirements. From our previous experience working in conventional CROs, we realised that procedures are sometimes too heavy and lead to a reduction in efficiency which can compromise your project timelines.
Our goal is to be inspection-ready at all times
Tools
At ExperTrials, we use the most highly efficient tools available in Clinical Research
eCRF : We provide you with the best Electronic Data Capture (EDC) softwares such as Rave Medidata, Medrio, Conform...
CTMS : Our efficient Clinical Trial Management System will allow you to access your clinical study data anywhere and anytime
eTMF : Archiving of essential documents throughout your study in electronic format.
eSignature : Signature process of essential documentation throughout the trial is simplified and reduce the costs by hundred of thousands euros
We provide excellence with high data quality, accessible anywhere, anytime and fully secured. You have access to your study data in real time.
0% paper, guaranteed 100% quality and GCP compliance.
A high turnover and assignments of junior CRAs in traditional CROs can compromise your clinical study*
At ExperTrials, we work with experienced Clinical Research Experts who have 10-20 years of experience in Clinical Research. These Experts will be assigned from the beginning of your clinical trial until completion. This will ensure that a high quality service is maintained throughout your trial.
PATIENT-CENTRIC APPROACH
Our primary concern at ExperTrials is the patient. We do not consider the patients as a data source, but as the drivers of our activity.
Since 2011, we at ExperTrials conduct international trials from phase I to phase IV, driven by a diligent market access analysis. We have significant experience in both pre-approval and post-approval trials.
We know that your timelines are extremely tight in order to get the data needed to support the next round of funding and take the next step in the advancement of your clinical development programme. We have the flexibility to respond to changes through all phases of your project, keeping in mind the patient first.
Extensive EXPERIENCE
We have extensive experience from all aspects of the global drug development industry. Our Project Managers are well equipped to work alongside our client teams to develop strategy, maneuver challenges, and drive teams to meet and exceed study goals.
Our expert team works closely with you to tailor the best solution for each project and to deliver clinical trials of the highest quality. We understand that each customer has unique needs and we work to design innovative, custom solutions across the full drug development life cycle.