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.
To manage and monitor all aspects of your trial
✔️ We support you in the preparation of your study documents: entire study protocol, IB, and review of your IMPD
✔️ Respect timelines with targeted patient recruitment and retention by setting up a robust recruitment plan
✔️ Identify challenges and opportunities for each site with operationalised protocol development and review
✔️ Lead with data-driven project management through consistent review of performance and trends thanks to efficient CTMS
✔️ Access to a vast network of renowned KOLs
To ensure compliance with all national and international regulations and guidelines
✔️ Documented procedures
✔️ Regularly updated SOPs
✔️ Quality Assurance training (e.g., vendors, sites, sponsor)
✔️ Quality Assurance Specialist
✔️ CAPA Management
✔️ Internal / external audits
For clinical and marketing authorization applications and maintenance
✔️ Consultation on legislation and country- specific requirements
✔️ Support with regulatory strategies
✔️ Preparing and filing IND/CTAs for drug or medical device
✔️ Multi-country submissions and effective follow-up to Competent Authorities and Ethic Committees
✔️ Substantial and non-substantial amendments throughout the clinical trials
✔️ Application for ODDs (+PIP) and expedited procedures
For clinical trial oversight, strategic consulting and medical writing
✔️ Review of study documents (protocol, CSR,CRF) and input in regulatory submissions
✔️ Reviewing all Serious Adverse Events (SAEs) and safety information
✔️ Recommending Key Opinion Leader (KOL) and Advisory Panel Networks
✔️ Ongoing Medical support with 24/7 availability
✔️ Investigator/Site selection and training
✔️ Protocol deviations assessment and review
✔️ Patient eligibility
✔️ Maintenance of Q&A logs
✔️ Medical review of ECGs and lab data
To ensure an optimal pricing and reimbursement strategy right from the beginning
✔️ Clinical Trial Design (advise on HEOR inputs for phase II/III…)
✔️ Market Access Dossier & Strategy
✔️ Health Economics and Outcomes Research (HEOR) data Generation
✔️ Real-Word Evidence Generation
✔️ Epidemiology
We can serve as your legal representative in the EU, handling local requirements on your behalf
✔️ The Legal Representative must be qualified and located in one of the EU’s Member States, but not necessarily in that Member State in which the study is conducted
✔️ ExperTrials is 100% compliant with the General Data Protection Regulation (GDPR), handling all EU data securely and ensuring participant privacy, so you can focus on your study with confidence.
« 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
To monitor patient safety throughout your clinical development programme
✔️ SAEs/SUSARs monitoring
✔️ Patient narratives
✔️ Annual safety reports and DSURs
✔️ Interim safety listings
✔️ SAEs reconciliation
✔️ Participation in Safety Advisory Board
✔️ Clinical trial risk management
✔️ Coding (MedDRA, WHO Drug) of adverse event information
✔️ Pharmacovigilance database
✔️ Eudravigilance registration
To take care of all aspects of data capture and analysis
✔️ Biostats and statistical programming activities including SDTM, ADaM, TFL, ISS/ ISE, Interim Analysis, IB/DSUR/DMC, FDA Briefing Book, publication support, PDF listing and Smart Listing. In addition, we perform data masking, data scrambling for blinded studies, as well as de-identification/anonymization based on special regulatory requirements.
✔️ Data Management activities include CRF design, clinical database build, medical coding (MedDRA and WHO Drug), SAE reconciliation and Database Lock.
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.